2016 News Briefs - International Neuromodulation Society

 
 

Earlier News:

Later News:



January - May 2016


Researcher Reports That the Rate of Sudden Unexpected Death in Epilepsy is Lower After Vagus Nerve Stimulation

May 30, 2016 - At the 2nd Congress of the European Academy of Neurology, a researcher from Switzerland presented an analysis of 24 years of data from the U.S. concerning vagus nerve stimulation (VNS) in epilepsy. The results suggest that patients who received VNS had a reduced risk of sudden unexpected death in epilepsy. (Medscape)

Newscast Features Research Interest in Potentially Treating Psychiatric Conditions with Brain Stimulation

May 27, 2016 - A newscast describes interest in using brain stimulation for psychiatric conditions, including depression and post-traumatic stress disorder. (CNBC)

Researchers Summarize Findings Concerning Brain Stimulation in Huntington's Disease

May 27, 2016 - International Neuromodulation Society members Jan Vesper, MD, PhD, and Lars Wojtecki, MD, and colleagues have published a review about brain stimulation in Huntington's disease that considers cortical excitability and plasticity in the disease and the potential therapeutic role of non-invasive or invasive brain stimulation methods. (Neurodegenerative Disease Management)

Review Presents Genetic Variations that May Contribute to Differing Responses to Brain Stimulation

May 26, 2016 - A review looks into research concerning combinations of genotypes that have been reported to interact with effects of brain stimulation. An expert commentary says that understanding the genetic factors affecting the heterogenous nature of patients' response to brain stimulation might help with selection of treatment candidates. (Expert Review of Neurotherapeutics)

Scientists Model Nerve Stimulation to Examine Safety Criteria

May 25, 2016 - A research paper about computer modeling of electromagnetic nerve stimulation concludes that a combined approach of accounting for realistic anatomies and neuronal dynamics offers value in establishing safety criteria. (Physics in Medicine and Biology)

Company Receives CE Mark Approval for Neurostimulation Device Targeting Back Pain

May 25, 2016 - Mainstay Medical International plc announced it has received CE mark approval for its implantable neurostimulation system to treat disabling chronic low back pain. The company plans a commercial launch in Germany. These plans include conducting a post-market clinical data follow up. A clinical trial in the U.S. may follow. (Business Wire)

Texas Company to Work With Pittsburgh Researchers on A Bladder-Control Implant for Spine-Injured Patients

May 24, 2016 - InCube Labs of San Antonio, TX has been awarded a $10 million subcontract, part of a U.S. Department of Defense contract, to work with the University of Pittsburgh on developing an implant that could improve or restore bladder function in patients who have suffered spinal cord injuries. (My SA)

TV Show Publicizes Montreal Clinical Trial of Non-invasive Neurostimulation for Gait Rehabilitation

May 23, 2016 - A television news show reports on a clinical trial into a non-invasive neurostimulation device that is applied on the tongue and is being investigated to augment physical therapy for gait in patients who have multiple sclerosis or suffered a traumatic brain injury. The news segment features a former U.S. talk show host and military veteran, Montel Williams. He has multiple sclerosis and became involved with the device's commercialization after having been one of its early study subjects. (CTV Montreal)

Article: Vagus Nerve Stimulation Offers Potential Promise in Addressing Obesity

May 21, 2016 - An article published in the United Arab Emirates describes hopes of being able to address obesity through vagus nerve stimulation, calling the concept "tweaking the behaviour of specific organs by remote control." (The National)

Academic Team Will Study Non-Invasive Brain Stimulation and Alzheimer's Disease

May 21, 2016 - The Fremont (Nebraska) Area Alzheimer’s Collaborative presented early stage research funding to Alzheimer's disease researchers at the University of Nebraska Medical Center. The researchers plan to use non-invasive brain stimulation to explore the role of the hippocampus in memory and cognitive function. (Fremont Tribune)

Young Girl Resuscitated After Almost Drowning Will Undergo Deep Brain Stimulation

May 20, 2016 - An article published in South Africa tells the story of a 6-year-old who will undergo deep brain stimulation for a movement disorder subsequent to a near-drowning at age 2. (Independent Online)

Device Company Announces Launch of MRI-Compatible Spinal Cord Stimulation System

May 19, 2016 - Boston Scientific Corporation announced it received FDA approval of its MRI-safe spinal cord stimulation system, which it will launch during the World Institute of Pain annual meeting, taking place May 20 - 23, 2016. The company said the FDA cleared the system for full-body, 1.5 Tesla MRI scans, and that it is designed to deliver multiple waveforms. (Mass Device)

Optogenetics Studies Move Beyond Retinal Applications to Potentially Address Pain or Other Conditions

May 19, 2016 - A news feature describes the start of a safety trial that is investigating an optogenetic intervention to potentially restore some vision to patients who have retinitis pigmentosa, through inducing retinal ganglion cells to produce light-sensitive proteins. Meanwhile, the article notes that preclinical work has begun to potentially use optogenetics to treat pain, via a light-sensitive patch worn on the skin. Other potential indications being considered for an optogenetic intervention include hearing, function of vocal cords, bladder function, and Parkinson's disease and other brain disorders. (Nature)

Twins Said to Be the First in Colorado to Receive Deep Brain Stimulation for OCD

May 18, 2016 - International Neuromodulation Society member David VanSickle, MD, PhD, was interviewed in a television newscast about treating what were said to be the first patients in Colorado to receive deep brain stimulation for obsessive compulsive disorder. He said he worked to convince the insurance company to cover the operation for a pair of young adult twin girls who were severely disabled by the condition. The patients said their symptoms have lessened since the treatment. Their story was also featured as a cover article in the Spring 2016 issue of the Littleton Adventist Hospital health magazine. In that article, Dr. VanSickle said the procedure has become "more consistent, faster, much less expensive . . . yet it's highly underutilized as a therapy." (9News.com)

Study: Spinal Cord Stimulation Helped Tetraplegic Patients Regain Some Use of Their Hands

May 17, 2016 - A publication reports that cervical spinal cord stimulation and motor training in two patients who had been paralyzed for more than 18 months following severe spinal cord injury allowed them to gain the ability to grasp and hold small objects. By the end of the study, the patients retained some improvement even after the stimulator was turned off. (National Institute of Biomedical Imaging and Bioengineering)

Physician Explains Interest in Neurostimulation for Cluster Headache

May 16, 2016 - A local T.V. segment focuses on a cluster headache patient in the Washington, D.C. area whose doctor is thinking of enrolling him in a clinical trial of sphenopalatine ganglion stimulation. (WUSA)

Researchers Model Effectiveness and Costs of Non-invasive Vagus Nerve Stimulation for Cluster Headache

May 16, 2016 - The company electroCore has issued a press release about research published last month showing that non-invasive vagus nerve stimulation for cluster headache is effective and cost-effective, according to scenarios modeled from a German health economy perspective. (PRLog)

Review Ponders Vagus Nerve Stimulation for Heart Failure

May 13, 2016 - A review of the INOVATE-HF controlled clinical trial of vagus nerve stimulation concludes that despite intriguing improvements in secondary endpoints, the approach "has to go back to the drawing board." The reviewer cite the lack of significant differences in the main endpoint of death or worsening heart failure, and the occurrence of device complications in almost one out of 10 patients. (NEJM Journal Watch)

Paper Calls Vagus Nerve Stimulation in Drug-Resistant Epilepsy a "Viable Alternative"

May 12, 2016 - A retrospective study of 20 patients with drug-resistant epilepsy who received a vagus nerve stimulation implant between 2001 and 2010 at two institutions in Turkey calls the treatment a "viable alternative" for patients who have drug-resistant epilepsy or who either could not have epilepsy surgery or did not benefit from it. (Univadis)

Review Looks at Incidence and Management of Postdural Puncture Headache After Spinal Cord Stimulator Implantation

May 12, 2016 - International Neuromodulation Society member Thomas Simopoulos, MD and colleagues found an incidence of 0.81% of postdural puncture headache following implantation of 745 spinal cord stimulation leads at a large academic medical center from 2002 to 2014. The six cases they reviewed all occurred before imaging via contralateral oblique fluoroscopic view entered the practice in 2011. They conclude that with meticulous aseptic technique, managing the puncture with epidural blood patch is safe and efficacious even in the presence of hardware. (Neuromodulation: Technology at the Neural Interface)

Electroceutical Startup Raises $8 Million

May 12, 2016 - An article reports that Silicon Valley startup NeuSpera Medical has raised $8 million in Series A financing for its injectable neuromodulation technology. The company was founded in 2014 as Vivonda Medical, and is targeting applications in electroceuticals, which the article calls "a futuristic field that already has substantial strategic interest." (Fierce Medical Devices)

Company Targeting Gastro-esophogeal Reflux Disease Raises $25 Million

May 12, 2016 - EndoStim, Inc. completed a Series D financing round of $25 million that will go in part toward clinical trials of its neurostimulation therapy for acid reflux. (PE Hub Network)

Company Announces Fast-Track Designation from the FDA

May 11, 2016 - Lungpacer Medical received approval to use the FDA expedited access pathway for its diaphragm pacing system. The system provides temporary transcatheter stimulation of the phrenic nerve to aid weaning patients from mechanical ventilation. (Mass Device)

Device Maker Releases First-Quarter Financial Report

May 11, 2016 - Nuvectra Corporation announced first-quarter financial results. The company's total revenue was $2.1 million, up 76% from the same quarter one year ago. Operating expenses were $8.1 million, a 42% increase from one year ago. The company completed its spin-out March 14. The company established a term loan agreement in March. Overall its net loss for the quarter was $0.70 per share, compared to $0.54 per share in the first quarter of 2015. The first commercial implants began in April for its first product, a spinal cord stimulation system. (Nasdaq)

Clinicians Present Data on Neuromodulation Device Outcomes for Bladder Indications

May 10, 2016 - A summary from a presentation at the American Urological Association's annual meeting reported data from a 5-year projection of comparative costs of percutaneous tribal nerve stimulation (PTNS) versus medical management. The data developed in London, U.K. led to a conclusion that PTNS has a greater overall cost, but is more effective than single or dual drug therapy and therefore provides reasonable value in treating overactive bladder. Another summary from the meeting concerned data from a single Cleveland, Ohio institution where 1,033 sacral neuromodulation procedures had an overall infection rate of 1.8%. In addition, the authors found the rate varied by primary indication. Non-obstructive urinary retention had higher rates, although the reason for this unexpected finding was not explored. (Uro Today)

Company's Pain-Relief Device Sales Were Higher Than Anticipated

May 10, 2016 - First-quarter sales for Nevro Corp. were higher than analysts' forecasts and the company raised its guidance about 2016 anticipated earnings. The company's spinal cord stimulation system received FDA approval last May. (Fierce Medical Devices)

Columnist: Are Non-drug Therapies Gaining Favor?

May 10, 2016 - A column discusses the total lifetime costs of drug therapies compared to neuromodulation therapy and mentions a recent article http://onlinelibrary.wiley.com/doi/10.1111/ner.12389/abstract in Neuromodulation: Technology at the Neural Interface. (Neurotech Business Report)

Researchers Pursue Potential Therapies Based on Vagus Nerve Stimulation

May 10, 2016 - An article describes some research in the European Union into advanced vagus nerve stimulation for obesity or inflammation. (Horizon)

Urologists Hear Analysis of Sacral Neuromodulation Study Data

May 9, 2016 - A physician who presented clinical research data about sacral neuromodulation at the annual meeting of the American Urological Association said the findings suggest that physicians should probably move to third-line therapies more quickly, after patients have failed just a few medications. The study of 272 subjects was a retrospective sub-analysis of a 5-year prospective study into the use of tined leads. (Urology Times)

Pilot Study Will Investigate Hypoglossal Nerve Stimulation in Certain Pediatric Patients Who Have Sleep Apnea

May 9, 2010 - A pilot clinical trial https://clinicaltrials.gov/ct2/show/NCT02344108?term=hypoglossal+nerve+sleep+apnea+down+syndrome&rank=1 of hypoglossal nerve stimulation for sleep apnea has started in pediatric patients with Down syndrome who cannot tolerate wearing continuous positive airway pressure masks at night. (Medical Xpress)

Company Plans a Stock Offering to Shareholders

May 9, 2016 - Second Sight Medical Products, Inc. is offering its shareholders subscription rights to purchase a proportionate amount of additional stock at $4.25 per share or 85% of the Nasdaq closing price by May 31, 2016. The proceeds will be used to fund operations and research, such as development of a cortical visual prosthesis as well as continuing a post-market clinical study of the company's retinal prosthetic for age-related macular degeneration. (Yahoo Finance)

Company Targeting Urogenital Indications Announces Patents

May 9, 2016 - Axonics Modulation Technologies, Inc. announced it received six U.S. patents relating to implantable neuromodulation technology and recharging systems in the past 12 months. The company said its initial clinical application is sacral neuromodulation to treat urinary and fecal dysfunction, which it said affects more than 100 million adults in the U.S. and Europe. (Yahoo Finance)

Review: Further Investigation of Potential Neuromodulation Therapies is Warranted in Memory-and-Learning Disorders

May 2016 - A review summarizes cortical-subcortical brain circuits that are important in learning and memory disorders such as Alzheimer's disease. The paper discusses mechanisms such as firing patterns, neural plasticity and neurogenesis, and goes over the current potential neurostimulation targets in those circuits, in addition to other possible therapies. (Journal of Neuroscience)

Paper Examines Importance of Total Charge Delivery Over Time in Spinal Cord Stimulation

May 6, 2016 - International Neuromodulation Society members Jonathan Miller, MD, Sam Eldabe, MD, Eric Buchser, MD, Lisa Johanek, PhD, Yun Guan, MD, PhD, and Bengt Linderoth MD, PhD published an article about spinal cord stimulation (SCS) that considers the overall rate of charge delivery, in addition to the the programming parameters of pulse width, amplitude, and frequency. The authors say SCS parameters that deliver different amounts of energy through different duty cycles may exert distinct therapeutic effects, such as little or no sensory perception of the stimulation. They say considering total charge delivery over time is a concept that applies to both conventional. tonic SCS and newer forms such as high frequency and burst stimulation. (Neuromodulation: Technology at the Neural Interface)

Pain Publication Covers International Neuromodulation Society Journal Article

May 6, 2016 - Coverage of an article about spinal cord stimulation and the emotional aspect of pain in Neuromodulation: Technology at the Neural Interface includes a comment from International Neuromodulation Society member Ali Rezai, MD. He said, “Being able to modulate the connections between the brain areas involved in emotions and those linked to sensations may be an important mechanism involved in pain relief linked to spinal cord stimulation.” (National Pain Report)

International Neuromodulation Society Member Investigates Potential New Brain Stimulation Target for Bipolar Disorder

May 5, 2016 - International Neuromodulation Society member Jennifer Sweet, MD, is beginning a clinical trial of deep brain stimulation (DBS) in bipolar disorder. In the first phase, in diffusion-weighted imaging of neural connectivity, medication-resistant patients will be compared to patients who respond to medication and to healthy controls. In the second phase, six medication-resistant patients who have abnormal connectivity will be recruited for a randomized, double-blinded pilot study of DBS targeting the rostral dorsal cingulum bundle, which plays a role in cognitive control. (University Hospitals Case Medical Center)

Meta-Analysis Summarizes Studies Comparing Deep Brain Stimulation Targets in Parkinson's Disease

May 4, 2016 - A review analyzes 16 studies that compare deep brain stimulation (DBS) to the subthalamic nucleus (STN) or the globus pallidus internus (GPi) in Parkinson's disease. The results show STN-DBS was more effective in reducing medication usage and GPi-DBS was more effective in resulting in a higher quality-of-life score. (Scientific Reports)

Computer Simulation Suggests Mechanisms Underlying Paresthesia-Free High-Frequency Spinal Cord Stimulation

May 4, 2016 - International Neuromodulation Society members Jeffrey Arle, MD, PhD, and Jay Shils, PhD, and colleagues have modeled high-frequency stimulation of dorsal column axons. According to their simulation, high-frequency, paresthesia-free stimulation leads to action potential blockade as hypothesized, preferentially occurring in larger diameter fibers, with recruitment of smaller and medium fibers. The effects arise from ion channel gate and virtual anode dynamics. (Neuromodulation: Technology at the Neural Interface)

Ongoing Clinical Trial of Deep Brain Stimulation in Alzheimer's Disease Explained

May 4, 2016 - A clinician involved in a study of deep brain stimulation in Alzheimer's disease was interviewed about the ongoing 10-person study to evaluate electrical stimulation of white matter in the ventral capsule of the frontal lobes, a region important in executive function and decision-making. (Medscape Multispecialty)

Review: Eligibility for Deep Brain Stimulation in Movement Disorders

May 3, 2016 - International Neuromodulation Society member Christopher Honey, MD, DPhil, and colleagues, published a review on currently available guidance about patient eligibility for deep brain stimulation in Parkinson's disease, tremor, and dystonia. (Canadian Journal of Neurological Sciences)

British TV Documentary Shows Tremor Relief from Deep Brain Stimulation

May 3, 2016 - The channel ITV will run a documentary of a man whose tremors were treated with deep brain stimulation. The show is part of the series "What Would Be Your Miracle?" about inspirational medical interventions. (Exeter Express & Echo)

Former Canadian Radio Host Appears in a Documentary about Deep Brain Stimulation for Parkinson's Disease

May 3, 2016 - A former radio announcer with Parkinson's disease is the subject of a documentary about his deep brain stimulation surgery. The film, "The Voice," is debuting at an international documentary film festival in Canada. (CBC News)

Neurostimulator Company Raises More Money in an Over-allotment Offering

May 3, 2016 - Helius Medical Technologies raised an additional $857,083 in an over-allotment to its latest offering, bringing the total to $8.1 million. The company said the proceeds will help fund completion of a clinical registry trial of its portable neuromodulation stimulator to evaluate treating traumatic brain injury, prior to seeking 510(k) clearance from the FDA. The company plans to also pursue indications in multiple sclerosis and stroke. (Mass Device)

Company Raises Capital to Commercialize Obesity-Treatment Neurostimulator

May 3, 2016 - EnteroMedics closed a third tranche in a $25 million offering, bringing in $6.3 million. The company is commercializing an implantable vagus nerve stimulator for obesity treatment. (Mass Device)

Device to Potentially Address Peripheral Nerve Pain Moves Forward in Competition

May 3, 2016 - Bioness, Inc. announced its implantable neurostimulator for peripheral neuropathic pain is a finalist for the 2016 Medical Device Excellence Awards. Results of the competition will be announced in June. (PR Newswire)

Columnist Sees Promise in April Developments in the Neurotechnology Industry

April 2016 - A column by an industry observer says that following St. Jude Medical's acquisition by Abott, other large healthcare firms may take greater interest in entering the neurotech arena. The column adds that proposed U.S. legislation, if passed, would require Medicare to automatically cover newly approved medical devices. Finally, the column notes the FDA is moving toward expediting access to market by considering lowering classification, from class III to class II, of cranial electrical stimulation systems for some indications. (Neurotech Business Reports)

Review Evaluates Evidence Base for Burst Stimulation

May 3, 2016 - A review of five published studies of burst spinal cord stimulation (SCS), involving 117 chronic pain patients, evaluates the evidence base and concludes that further study should use a standardized design, a large sample of patients who have not previously had SCS, and entail long-term follow-up. However, the study notes that new mechanisms may be at play in this stimulation mode, according to animal studies, and says, "understanding other potential spinal inhibitory mechanisms may lead to enhanced analgesia during burst stimulation." (Neuromodulation: Technology at the Neural Interface)

Editorial Considers Tailoring of Deep Brain Stimulation in Depression

May 2, 2016 - Commenting on a recent study into deep brain stimulation (DBS) for treatment-resistant depression, a psychiatrist notes that symptom improvement in the blinded study was not a placebo effect, and dosage adjustment led to better results. He adds that electrode placement may also be reconsidered as the potential intervention evolves, saying, "DBS is most likely to become a viable choice for highly refractory major depression when electrode location is matched to individual pathophysiology as indicated by functional neuroimaging." (NEJM Journal Watch)

Review Recounts History of Deep Brain Stimulation

April 29, 2016 - A review looks at the development of brain neuromodulation techniques and the current state of the art, including new research into stimulation using ultrasound, micro-scale magnetic fields and optogenetics. (Neuroscientist)

Researchers Report Non-invasive Brain Stimulation Led to More Cortical Excitability and Higher Pain Thresholds

May 2, 2016 - Researchers report a more-robust non-invasive brain stimulation method that increases cortical excitability and may help in devising interventions that raise the pain threshold for patients suffering from chronic pain. They used two electrodes on one side of the head and ran a constant low-intensity current between the electrodes for 10 minutes. Compared to previous studies that only used a single site for transcranial direct current stimulation (tDCS), this method, unihemispheric dual site tDCS, led to more-pronounced and more durable cortical excitation that lasted 24 hours, they report. Further tests showed that participants had an increased pain threshold. (Health Canal)

Neuromodulation Company is Acquired by Healthcare Giant

April 28, 2016 - Abbott is acquiring St. Jude Medical, Inc. for $25 billion. The deal provides a broader cardiovascular portfolio and also confers "a leading position in the high-growth neuromodulation market," it was reported today. Abbott, which has product lines in cardiovascular, diabetes, and vision care, will assume or refinance St. Jude's net debt of approximately $5.7 billion. (Street Insider)

Researchers Explore Non-Invasive Brain Stimulation in Alzheimer's Disease

April 27, 2016 - A pilot study in the Journal of Alzhemier's Disease explored, in 18 patients with mild, moderate, or severe Alzhemier's disease, a potential alternative brain-stimulation method to restore mental function. The researchers reported that there were temporary improvements in thinking skills and memory after six sessions of exposure to sound pulses at 40-hertz. This gamma wave rhythm has been shown to be a fundamental frequency of a healthy brain. The study builds on 2013 findings showing that vibrations delivered through the index finger stimulated a steady 40-hertz oscillation in the brains, as seen in magnetoencephalography. (The Globe and Mail)

Researcher Explains Obesity Research at Science Festival

April 26, 2016 - A talk at TechfestNW in Oregon presented the rationale for investigating deep brain stimulation of the hypothalamus as a therapeutic intervention in obesity. (Willamette Week)

News Feature Surveys the State of Research Into Minimally Conscious State

April 26, 2016 - An article about minimally conscious states mentions deep brain stimulation that helped to restore more conscious awareness to one patient. (Newsweek)

Authors Recount State of an International Registry of Tourette Syndrome Patients Who Have Received Deep Brain Stimulation

April 25, 2016 - A review details an international registry of patients with Tourette syndrome who received deep brain stimulation. The registry has 157 patients so far, from 10 countries. The review lists 16 studies published since 2007 that have more than four patients who received DBS as an investigational intervention in Tourette syndrome. (Frontiers in Neuroscience)

Review Summarizes Neuromodulation Studies in Heart Failure

April 25, 2016 - A review examines clinical experience with studies of spinal cord stimulation and vagus nerve stimulation in heart failure, as well as baroreceptor activation therapy. The review analyzes challenges of determining proper excitation parameters and/or stimulator duty cycles, among other issues. Despite challenges, the authors say much progress has been made in the past five years and that one day clinicians may use both devices and drugs to restore the proper sympathovagal balance in heart failure. They add that enrollment will begin soon in a large pivotal trial, BeAT-HF (Barostim Therapy for Heart Failure; NCT02627196). In it, 480 heart-failure patients will be randomized to receive optimal medical therapy with or without BAT. Results, however, will not be expected for several years. (Basic to Translational Science)

Study: Varying Stimulation Frequency May Aid Pain Control

April 22, 2016 - International Neuromodulation Society member Julie Pilitsis, MD, PhD and colleagues published results of a pain study involving 19 patients receiving deep brain stimulation. The authors found that low-frequency stimulation modulates thermal and mechanical detection more than high frequency stimulation, as determined through quantitative sensory testing. They postulate that low frequency stimulation may be an option to consider for patients with Parkinson's  disease whose pain is their predominant complaint. (Journal of Neurosurgery)

Modeling Indicates that Adjunctive Neurostimulation in Chronic Cluster Headache Would Improve Outcomes and Lower Treatment Costs

April 22, 2016 - Using data from a prospective, randomized, open-label study of non-invasive vagus nerve stimulation, researchers in Germany modeled the cost-effectiveness of this adjunctive treatment for chronic cluster headache compared to the current standard of care alone. Their analysis found that after one year, the combined treatment of vagus nerve stimulation plus standard care was projected to result in greater quality of life and lower healthcare expenditures in a German setting. (The Journal of Headache and Pain)

New Neurostimulation Company Receives up to $45 Million in Debt Financing

April 22, 2016 - Nuvectra's first disclosed financing is a $40 million loan and $5 million line of credit from Oxford Finance and Silicon Valley Bank. The newly spun-out neurostimulation company's overall market capitalization is about $90 million. (Fierce Medical Devices)

Company Acquires Startup's Neurostimulation Patents

April 22, 2016 - Nexeon MedSystems Inc. has acquired neuromodulation patents from NeuroTek Medical, Inc. related to electrode design and occipital nerve stimulation for migraine headache. NeuroTek created a device that delivers transcutaneous occipital nerve electrical stimulation as an investigational treatment for migraine pain. Nexeon anticipates using this intellectual property in its research into similar technology for cardiovascular disease, cognitive enhancement, and sepsis. (Biospace)

CE Mark Approved for Migraine Prevention Labeling

April 22, 2016 - The company eNeura has received an expanded CE mark for its single-pulse transcranial magnetic stimulation device to prevent migraine, as well as for acute treatment of migraine. (FDA News)

Article Recaps Researchers' Non-invasive Brain Stimulation Research

May 2016 - A news feature describes military-funded research that examines cognitive effects of non-invasive brain stimulation. The Insight project, begun in 2014 with $12.7 million from the U.S. Office of the Director of National Intelligence, combines physical fitness training, nutrition monitoring, and cognitive training sessions that include transcutaneous direct current stimulation in healthy volunteers. The 42-month project tracks adaptive reasoning in novel situations. (Smithsonian)

Cadaver Study Measured External Stimulation Entering the Skull

April 20, 2016 - Unpublished data presented at the annual meeting of the Cognitive Neuroscience Society earlier this month in New York City showed very little current entered a cadaver's skull which was fitted with transcutaneous electrodes to deliver alternating current, with most applied current shunted away by the skin. Regarding the findings, one researcher commented that transcutaneous brain stimulation in living subjects is not expected to deliver a stimulus strong enough to trigger neuron firing, but instead to make neurons more likely to fire or form new connections. In addition, he noted that living tissue conducts electricity differently. (Science)

Early-Onset Parkinson's Disease Patient in Scotland Appreciates Neuromodulation Therapy

April 20, 2016 - A retired teacher who belongs to the Glasgow Young Onset Parkinson’s Group discussed being able to receive deep brain stimulation (DBS). The article says that at a cost of around £70,000 to the National Health Service, only 10 to 12 operations are carried out a year. (Daily Record)

Survey Underscores Importance of Realistic Therapy Expectations in Parkinson's Disease Patients

April 20, 2016 - Survey results presented at the 2016 annual meeting of the American Academy of Neurology showed that Parkinson's disease patients whose pre-operation expectations were realistic had improved quality-of-life scores after their deep brain stimulation (DBS) surgery. The article states that "most patients continued to be satisfied with their decision to undergo DBS, would elect to undergo the procedure again if necessary, and would recommend the procedure to others. In addition, most participants reported that they would have preferred to undergo DBS earlier." (Neurology Advisor)

Research Team Unravels Dual Role of Brain Nucleus Neurons

April 20, 2016 - Preclinical experiments untangled a dual role for cholinergic neurons in the pedunculopontine nucleus by following projections to midbrain structures. The work indicates that to address gait issues in movement disorder, brain stimulation might target the axonal projections in the substantia nigra. For reward disorders, on the other hand, stimulation might target projections in the ventral tegmental area. (Medical Xpress)

FDA Ponders External Brain Stimulation Device Classifications

April 20, 2016 - The FDA is receiving comments on its proposal to reclassify cranial electrotherapy stimulator devices from Class III to Class II for insomnia and/or anxiety, while remaining Class III devices when intended for depression, requiring premarket approval. (Medical Device and Diagnostic Industry)

Transcranial Magnetic Stimulation System Maker Announces New European Patent

April 20, 2016 - Nexstim Plc announced the European Patent Office has issued a patent for the company's technology that displays where an electric field is generated on the brain during transcranial magnetic stimulation. (Globe Newswire)

Device Maker Cites Neuromodulation Revenue in Quarterly Earnings

April 20, 2016 - Neuromodulation sales at St. Jude Medical grew 8% in the first quarter and contributed to earnings and revenues the company said were above forecast. (Market Watch)

Paper Compares MRI Capabilities in Guiding Targeting of Deep Brain Stimulation

April 20, 2016 - Co-authors from the University of California, San Francisco compared deep brain stimulation (DBS) lead targeting during one year of operation using magnetic resonance imaging from ether a 3-tesla magnet (23 consecutive leads) or a 1.5-tesla magnet (26 consecutive leads). They concluded that accurate DBS lead targeting can be achieved with systems using either 1.5- or 3-tesla magnets, but a 3-tesla magnet provides better visualization of the target structures. (Stereotactic and Functional Neurosurgery)

Neurostimulation Spin-off Completes Private Financing Round

April 19, 2016 - A spinoff from the Swiss Federal Institute of Technology in Lausanne, G-Therapeutics, raised $41 million in a Series A round and debt. The company plans to use the proceeds on clinical trials for an implantable neurostimulation system to restore lower limb function spinal cord injury patients. (Fierce Medical Devices)

Non-invasive Stimulation Startup Raises Capital

April 18, 2016 - Helius Medical Technologies has raised $7.2 million in a Canadian short-form offering and a concurrent private placement in the U.S. The company is completing a clinical trial of non-invasive nerve stimulation for treatment of traumatic brain injury, in preparation for a request for FDA 510(k) clearance and an envisioned U.S. commercial launch. (Med City News)

Study: Non-invasive Vagus Nerve Stimulation Reduced Menstrual Migraine Frequency and Intensity

April 19, 2016 - An open-label study of 56 patients presented at the American Academy of Neurology meeting showed that non-invasive vagus nerve stimulation reduced the frequency of menstrual migraine by 35%, down to 4.7 episodes per cycle. The migraine episodes were also less intense, resulting in 38% less use of rescue/analgesic medication. Another study at the meeting provided evidence that the non-invasive stimulation is stimulating afferent vagus nerve fibers as expected. (Newswire)

Researchers Analyze Effect of Responsive Neurostimulation in Patients with Treatment-Resistant Epilepsy

April 18, 2016 - An analysis of 106 patients with medically intractable mesial temporal lobe epilepsy who participated in a clinical trial of responsive neurostimulation showed a median seizure reduction of 70%, according to data presented at the American Academy of Neurology meeting. (Neurology Advisor)

Spinal Cord Stimulation Leads Receive Pre-Market Approval

April 18, 2016 - Nevro Corp. announced FDA pre-market approval of its spinal cord stimulation leads for use with its high-frequency spinal cord stimulation device, which was FDA-approved in May 2015. (Mass Device)

Review Foresees Potentially Greater Role for Neuromodulation in Treatment-Resistant Depression

April 2016 - A review of electroconvulsive therapy, transcranial magnetic stimulation (TMS), and deep brain stimulation (DBS) in treatment-resistant depression concludes that as additional knowledge is developed about the best use of the latter two treatments, circumstances may allow TMS and DBS to become mainstream treatments for treatment-resistant depression in the next decade. (Healio Psychiatric Annals)

Researchers Say Non-invasive Brain Stimulation Improved Cognitive Reasoning on a Word-Analogy Test

April 14, 2016 - An article in Cerebral Cortex says research subjects performed better on a novel analogy-finding task after receiving high-definition tDCS-to the frontopolar cortex, an area whose activity was recently shown to predict changes in creative state. (Science Daily)

Journal Features Work of International Neuromodulation Society Members to Reanimate the Limb of a Quadraplegic

April 13, 2016 - The New York Times covered the publication in Nature of research including International Neuromodulation Society members Ali Rezai, MD, and Chad Bouton regarding their collaboration to use a motor-cortex implant and an electrode sleeve to reanimate the hand and arm of a man with quadriplegia. Nature published an associated news article. An article by the BBC includes a video of the young man using the device. Ohio State University issued a news release saying the patient is the first of up to five to participate in the clinical study using this "neural bypass" system, NeuroLife. Bouton was recognized for this work in 2015 as one of five winners of the inaugural INS biennial congress abstract competition. (New York Times)

Study: Deep Brain Stimulation Target Yielded Lasting Symptom Improvement in Parkinson's Patients

April 13, 2016 - Researchers in Mexico City report that unilateral deep brain stimulation to the preleminiscal radiations (Rapri) in patients who have Parkinson's disease in stages II - III induced significant improvement in contralateral symptoms in the extremities over 2 - 4 years of followup. Fourteen of the 19 patients had more than an 80% decrease in symptoms. The other five had symptom decreases of 33 - 79%. (Neuromodulation: Technology at the Neural Interface)

Advocacy Group's Survey in Ireland Shows Limited Access to Deep Brain Stimulation

April 13, 2016 - An article about a survey of 1,000 patients by the Parkinson’s Association of Ireland says that despite Parkinson's disease being on the rise, only 3% of patients have had access to deep brain stimulation. For the treatment, they must travel to England, which is difficult for patients whose condition limits their mobility. (Irish Times)

Man with Autism Recounts His Response as a Non-invasive Brain-Stimulation Subject

April 13, 2016 - In a "Science of Us" column, a writer interviews a man with autism about his experiences as a clinical research subject who had repetitive transcranial magnetic stimulation in an attempt to mitigate some of his symptoms that interfered with socialization. (New York Magazine)

Company Releases Dorsal Root Ganglion Neurostimulator in the U.S.

April 11, 2016 - St. Jude Medical announced the U.S. launch of its dorsal root ganglion (DRG) neurostimulator, following FDA approval in February. Providers are being trained in use of the device to treat people with chronic pain from complex regional pain syndrome I and II for whom traditional neurostimulation is not sufficiently effective. The company announced the first two procedures in a news release and said it has partnered with implanting chronic pain specialists who will conduct more than 100 procedures in 59 centers nationwide in the first month after launch. (MedGadget)

Authors Foresee Applying Laboratory Findings in Optogenetics to Deep Brain Stimulation Therapy

April 5, 2016 - Authors of a research review posit that optogenetics in animal models can identify neural circuits thought to contribute to behavioral disease, which then might be treated with deep brain stimulation. These possibly novel stimulation targets could be validated in the animal models. Then, the findings might be translated to humans. (Swiss Medical Weekly)

Small Clinical Trial Starts to Potentially Remedy Vision Loss with Optogenetics

March 18, 2016 - A woman in Texas with loss of vision from retinitis pigmentosa is the first participant in a small clinical trial to receive optogenetic therapy. The treatment introduces genes for light-sensing proteins to ganglion cells in her retina. The intent is to allow these cells to signal the presence of light, and thereby restore some ability to perceive light and shadow. Restoring some vision could help patients better perceive and navigate their environment. (MIT Technology Review)

Clinical Trial of Neurostimulation in Post-Amputation Pain Will Continue Following Interim Analysis of Early Results

April 7, 2016 - Neuros Medical, Inc. announced positive feedback from an analysis of interim results in the company's pivotal clinical study of high-frequency nerve stimulation for post-amputation pain. An independent data monitoring committee analyzed safety and efficacy outcomes for the first 20 patients in the study. Based on that analysis, the clinical trial will continue. The study seeks to ultimately enroll up to 130 patients at 15 institutions. (Business Wire)

Researchers Explore Potential Deep Brain Stimulation Target to Treat Pain

April 4, 2016 - The University of Texas at Arlington issued a news release about preclinical research into neurostimulation for pain that targets the ventral segmental area, a brain structure that plays roles in both the reward process and nociception. The researchers write in Experimental Brain Research that the stimulation may cause an analgesic effect and decrease nociceptive pain via descending modulatory pathways, possibly through connections to the brainstem and cerebral cortex. (Medial Xpress)

Public Body Says National Health Service Can Use Noninvasive Vagus Nerve Stimulation for Chronic Headache

April 1, 2016 - In a news release, electroCore LLC reports that the National Institute for Health and Care Excellence (NICE) has issued guidance on transcutaneous stimulation of the cervical branch of the vagus nerve for cluster headache and migraine. NICE reviewed and summarized results of five clinical trials that documented the degree of benefit experienced by enrollees. The guidance to physicians encourages them to inform patients that evidence of efficacy is uncertain due to the extent and nature of the data published to date, but adds that further research is encouraged and "current evidence raises no major concerns". Based on the guidance issued by NICE, the intervention can now be used in the National Health Service. (PR Newswire)

Company Evaluates Response of Stroke Patients to Different Forms of Noninvasive Stimulation

March 31, 2016 - Nexstim Plc of Finland plans to file for FDA 510(k) clearance for its navigated repetitive transcranial magnetic stimulation system in the second quarter of 2016, the company announced. The system is CE marked, and was undergoing a clinical trial at 12 centers in the U.S. to augment post-stroke arm and hand motor rehabilitation. The sham group received a different stimulation than the patients in the active-treatment arm. After 138 patients were treated, the study reached a futility criterion because both the sham and treatment groups showed clinically meaningful gains, with more than two-thirds of patients in each group responding. The company is filing a patent application on the sham stimulation method, based on this unexpected response. The company is halting the clinical trial and will unblind the data for further analysis. (Globe Newswire)

Retinal Prosthesis Maker Gets CE Mark Approval

March 31, 2016 - Retina Implant of Germany received CE Mark approval for its neuroprosthetic device designed to restore some vision in patients who have retinitis pigmentosa. (FDA News)

Pilot Trial of a Wearable Pain-Relief Device Will Gather Data on Sleep Impact Through a Mobile App

March 31, 2016 - NeuroMetrix will offer its FDA-cleared wearable pain-relief device to people with chronic pain who work for Premera Blue Cross in the Pacific Northwest in a pilot trial in which data on device utilization and sleep quality will be gathered by a mobile app. (FDA News)

Researcher Looks at Role of Modulation of Neural States in Motor Tasks

March 31, 2016 - In a finding that may help development of prosthetic devices, a researcher in Sweden reported in Current Biology that the signal patterns of sensory neurons associated with muscle spindles changed during learning of a motor task. Earlier, the researcher noted in an interview that insight into these mechanisms can also aid understanding of pathological states, such as spasticity. (Science Magazine)

Physiologist Finds Some Capacity for the Spinal Cord to Adapt After Injury

March 30, 2016 - A news feature covers four decades of research by a physiologist whose neurostimulation studies have led to an understanding that following some spinal cord injuries, the spinal cord can adapt through neurorehabilitation and generate patterns of activity that have allowed some paralyzed research subjects to recover some limited function. (STAT)

Researchers Investigate Stimulation of the Ventral Tegmental Area in Chronic Cluster Headache

March 30, 2016 - British researchers report a prospective study of 21 patients who have medically refractory chronic cluster headache, and were treated with deep brain stimulation to the ventral tegmental area after either failing occipital nerve stimulation or having been denied it through the National Health Service. They report that patients improved significantly in a number of factors. The authors conclude that the study provides Class IV evidence that this intervention in this medically refractory condition decreases headache frequency, severity, and headache load. (Neurology)

Company Launches a Minimally Invasive Neurostimulation Treatment for Overactive Bladder

March 30, 2016 - Medtronic plc has launched a percutaneous tibial nerve stimulation system to treat symptoms of overactive bladder. (Yahoo Finance)

Article Describes Interest in Bioelectronics

March 29, 2016 - An article describes the development of bioelectronics or electroceuticals following an observation in 2002 that an agent under investigation to limit swelling after a stroke was affecting the vagus nerve and the reaction of the immune system. The observation led to the concept that the nerve could be manipulated with electrical impulses instead of a pharmaceutical agent. (Wired.uk via Unknown Country)

Case Report: Pudendal Nerve Stimulation in Pediatric Patent with Caudal Regression

March 28, 2016 - Physicians report on the use of pudendal nerve stimulation in a pediatric patient to treat the patient's refractory bladder/bowel dysfunction. Sacral neuromodulation was not pursued because the patient had a malformed lower spine due to caudal regression. (Urology)

Noninvasive Brain Stimulation Researcher Seeks Enrollees with Parkinson's Disease to Investigate a Potential Depression Therapy

March 28, 2016 - A researcher at the University of British Columbia is recruiting Parkinson's disease patients who have been diagnosed with depression to see if two weeks of daily sessions of transcranial direct current stimulation at home will help relieve symptoms. News coverage of his work highlights cautions that researchers and industry-watchers have voiced about the home use of brain-stimulation devices that are not regulated as medical devices. (Vancouver Sun)

Deep Brain Stimulation Affects Oscillation of Distinct Networks in Parkinson's Disease

March 26, 2016 - Researchers in the United Kingdom published findings showing that motor improvement in Parkinson’s disease patients receiving subthalamic deep brain stimulation correlates to suppressed synchrony of distinct brain networks. The findings were based on simultaneous magnetoencephalography recordings of the subthalamic nucleus and cortex. The authors conclude that further defining the activity of cortico-subcortical loops, and their connection to underlying symptoms, might aid development of patient-specific treatment that tailors the delivery and pattern of brain stimulation. (Brain)

Neurologists Document Infection Rates Following Deep Brain Stimulation Implantation in a Diagnostic MRI Suite

March 25, 2016 - Physicians at the University of California, San Francisco prospectively collected data over 10 years from 164 procedures in which deep brain stimulation leads were implanted under MRI guidance in a sterile setting that lacked the air-handling qualities of operating rooms. They changed their sterile practice after the first 10 patients. Subsequently, the next four instances of postoperative hardware infection (2.6% of 154 patients) all occurred at the site of the implantable pulse generator, which had been implanted in a conventional operating room during a followup visit. In the whole group of patients, there were six infections for an overall rate of 3.6%. (Brain)

Ukraine Patient Received Deep Brain Stimulation System

March 27, 2016 - A boy with epilepsy received a deep brain stimulation (DBS) system in what is described as the first surgery of its type in the Ukraine. (Ukraine Today)

Neuromodulation Center Joins Forces with Brain Science Institute

Summer 2016 - The Asia-Pacific Centre for Neuromodulation officially joined the Queensland Brain Institute in January. The neuromodulation-therapy research center was formed in 2012 as a joint initiative of the University of Queensland and St. Andrew’s War Memorial Hospital. (University of Queensland)

Pilot Study Explores Medication-Free Maintenance Following Transcranial Magnetic Stimulation for Depression

March 24, 2016 - A prospective pilot study in Brain Stimulation  randomized unmedicated patients with unipolar, nonpsychotic, treatment-resistant major depressive disorder to either observation, or monthly transcranial magnetic stimulation (TMS) sessions following a six-week acute-treatment phase. The patients in the randomized phase were among 49 responders who were followed for up to 12 months, out of 67 total who underwent the initial acute phase of treatment. Compared to the observation group, the ones who had been randomized to receive monthly treatment were able to go 91 days before intensive therapy needed to be introduced, compared to 77 days in the observation-only group, the article states. (Fierce Medical Devices)

Company Starts to Market Peripheral Nerve Stimulator

March 23, 2016 - Stimwave, LLC said it has begun to market its peripheral nerve stimulator that received 510K approval from the FDA earlier this month. Its indications include upper and lower extremity neuropathies and some pain of the mid or lower back, chest well, abdomen, or pelvic region.The device is wirelessly powered by a wearable fabric patch unit. (Business Wire)

Researchers Investigate Non-invasive Brain Stimulation in Anorexia

March 23, 2016 - An article in PLOS ONE suggests repetitive transcranial stimulation (rTMS) to the dorsolateral prefrontal cortex reduced symptoms of anorexia. The researchers saw a statistical trend toward reduced symptoms in the active-stimulation group following one session of rTMS to this area of the brain, which is thought to be involved in some of the self-regulation difficulties associated with anorexia. (Medical Xpress)

Study Examines Role of Brain Structure in Propensity to Make Eye Contact

March 23, 2016 - Researchers in France published findings in which subjects whose superior temporal sulcus was inhibited by transcranial magnetic stimulation gazed less at the eyes of movie actors. The authors say this brain structure is different in some autistic people. They want to explore whether stimulating its activity could serve as a therapy to enhance social interactions by increasing eye contact. (Medical Xpress)

Laboratory Brain-Stimulation Study Targets Circuits Involved in Feeding and Metabolism

March 23, 2016 - A feeding-and-metabolism study in Nature, Nature  "Bidirectional electromagnetic control of the hypothalamus regulates feeding and metabolism," investigated glucose homeostasis through stimulating the hypothalamus of mice via radio or magnetic waves. In the laboratory animals, the stimulation affected a ferritin fusion protein tethered to a calcium-ion pore. The authors note that "pancreatic hormones function as an effector mechanism of central nervous system circuits controlling blood glucose and behaviour. The method we employ obviates the need for permanent implants and could potentially be applied to study other neural processes or used to regulate other, even dispersed, cell types." (Rockefeller University)

Cluster Headache Patient in Wales Wishes to Try Neurostimulation

March 23, 2016 - A woman in Wales says she has not gotten approval to receive occipital nerve stimulation (ONS) for her cluster headache. Authorities said 2013 guidance from the National Institute for Health and Care Excellence does not support ONS on a routine basis. (The Leader)

Call for Congress Proposals Issued

March 2016 - For its 13th World Congress, "Neuromodulation: Technology Changing Lives" May 21 - June 1, 2017 in Edinburgh, Scotland, the International Neuromodulation Society seeks proposals by May 1 regarding basic science, clinical studies and biomedical engineering presentations about neuromodulation for:

    Brain disorders, including epilepsy, Parkinson's disease, dystonia, traumatic brain injury, stroke, psychiatric disorders, etc.;
    Chronic pain conditions that are underserved;
    Cardiovascular disorders, including heart failure, angina, and peripheral vascular disease;
    Systemic disease;
    Pelvic organ motility disorders; and
    Neurorehabilitation; as well as
    Mechanisms of action of neuromodulation; and
    Non- and less-invasive neurostimulation.
(International Neuromodulation Society)

Mice Studies Indicate Astrocytes Help Mediate Effects of Transcranial Direct Current Stimulation

March 22, 2016 - Researchers in Japan report in Nature Communications on an apparent mechanism of action of transcranial direct current stimulation (tDCS), seen in mouse studies. Fluorescent tagging indicated tDCS induced large surges of calcium ions in astrocytes, implicating activity of these non-nerve cells in mediation of neuronal responses to the stimulation. They add that there were no obvious changes in the local field potential. They suggest this tDCS mechanism may play a role in lowering symptoms of depression and increasing learning and brain plasticity. In a mouse model of stress-induced depression, tDCS normally reduces depression-like behavior. However, when astrocytic calcium surges were blocked, it did not. The researchers also found tDCS enhanced cortical responses to sensory input, such as light flashes or whisker deflection. (EurekAlert)

Specialists Urge Progress on Deep Brain Stimulation Center in Scotland

March 22, 2016  - Twenty-five specialists have sent an open letter to the health secretary asking her to resolve a funding dispute that has delayed establishment of a deep brain stimulation (DBS) center in Scotland for patients in north and east, who must travel to England for the treatment. (BBC)

News Release Publicizes Study Data About Neurostimulation Reducing the Emotional Aspect of Pain

March 17, 2016 - International Neuromodulation Society member, Ali Rezai, MD, was quoted in a news release about an article he published with colleagues, including fellow member Louis Vera-Portocarrero, PhD, in the current issue of Neuromodulation: Technology at the Neural Interface. He said, "spinal cord stimulation can reduce the emotional connectivity and processing in certain areas of the brain in those with chronic pain." The researchers examined functional MRI scans of 10 patients who had spinal cord stimulation (SCS) for complex regional pain syndrome or chronic leg pain. The findings suggest SCS reduces negative pain processing through decreasing connectivity of the limbic and somatosensory areas. (EurekAlert)

Brain Stimulation Boosted Recall of a Short-Term Memory in a Mouse Model of Alzheimer's Disease

March 16, 2016 - Optogenetic studies in a mouse model of Alzheimer's disease showed that stimulation of the hippocampus can elicit recall of an earlier painful stimulus (a box that delivered an electric shock). Normal mice learned to fear the box, but the mice designed to model Alzheimer's disease did not. When the memory-impaired mice received the brain stimulation, however, they did not move about the box, indicating they associated it with the shock. Cycling the simulation on and off as might occur naturally during repeated memory recall allowed the mice to retain and retrieve the memory, and dissection later indicated that repeated stimulation led to more connections between the hippocampus and the entorhinal cortex. (Nature)

Study: Noninvasive Brain Stimulation Enhanced Motor Recovery

March 16, 2016 - A controlled study of transcranial direct current stimulation (tDCS) during stroke rehabilitation in 24 patients showed that the half who received active stimulation in conjunction with nine days of motor rehabilitation performed better at three months' followup than those who did not. The researchers applied anodal stimulation to the brain hemisphere ipsilateral to the lesion. (Medical Xpress)

Military Research Agency Seeks to Use Peripheral Nerve Stimulation to Enhance Cognitive Performance

March 16, 2016 - The U.S. Defense Advanced Research Project Agency (DARPA) announced a new peripheral-nerve-stimulation research program, Targeted Neuroplasticity Training (TNT), and will hold a Proposer's Day on April 8, 2016 in Arlington, VA. The research program concerns noninvasive nerve stimulation, and seeks to facilitate learning of cognitive skills "with a goal of reducing the cost and duration of the Defense Department’s extensive training regimen while improving outcomes," the announcement said. Unlike prior research programs, "it will aim not just to restore lost function but to advance capabilities beyond normal levels." (DARPA)

Two-Year Pilot Study Finds Early Deep Brain Stimulation in Parkinson's Disease Lowered Medication Costs

Feb. 26, 2016 - International Neuromodulation Society members Peter Konrad, MD, PhD, Fenna Phibbs, MD, and Joseph Neimat, MD, have published with co-authors a prospective, randomized, single-blind clinical trial testing the impact of subthalamic nucleus deep brain stimulation (DBS) in early Parkinson's disease on reduced medication costs. The 30-patient study found that over two years, patients who were randomized to only receive optimum drug treatment had their medication costs increase 72% from baseline. In the same period, the patients who also received DBS had their medication costs drop 16%. The cost savings amounted to $7,150 over two years. (Journal of Parkinson's Disease)

Neurostimlation Company Spinout Concludes With Stock Exchange Listing

March 14, 2016 - Nuvectra Corporation began trading under the symbol NVTR, completing its spinout from Greatbatch, Inc. Nuvectra's chief executive officer, Scott Drees, said the newly independent neurostimulation medical device company will begin focusing on launching its proprietary spinal cord system in the U.S.. (Yahoo Finance)

Company"s Robotic Surgery System to Assist in Deep Brain Stimulation Surgery

March 14, 2016 - Montpellier-based Medtech announced sale of its brain robotic surgery system to the Yale School of Medicine's Comprehensive Epilepsy Center, where its uses will include deep brain stimulation surgery. The company said two additional units were sold in China, bringing their total there to nine. (Nasdaq.com)

Report Issued on FDA Workshop Concerning Brain-Computer Interfaces

April 2016 - International Neuromodulation Society member John Donoghue, PhD, is among authors of a report that has been published following a November 2014 FDA meeting on brain-computer interfaces (BCI)  for patients with paralysis or amputation. The report says FDA plans to develop guidance for premarket submissions for BCI devices. For the purposes of the workshop, BCI devices were defined as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. (Journal of Neural Engineering)

Researcher Explores Minimizing Scar-Tissue Formation With Drug-Eluting Implant

April 2016 - International Neuromodulation Society member James FitzGerald, PhD, has published preclinical data regarding suppression of scar tissue formation in peripheral nerve implants. His work involved a microchannel implant on the sciatic nerve of rats made of silicone doped with the inflammation-suppressing steroid dexamethasone. After periods of up to one year, the drug-eluting implants had less surrounding scar tissue compared to controls. Axon growth was initially much stronger in the control versions, but declined as scar tissue formed, whereas axon counts increased in the drug-eluting devices and by one year were significantly higher than controls. (Journal of Neural Engineering)

Computational Model Seeks to Help Guide and Explain Deeper Stimulation from Transcranial Magnetic Stimulation

April 2016 - A research team has modeled the brain's white fiber tracts, that connect cortical and subcortical regions and are theorized to potentially propagate action potentials toward deeper brain regions during transcranial magnetic stimulation. Their model, they say, combines electromagnetism and electrophysiology by computing, next to the induced electric fields in the brain, the spatial distribution of the membrane potentials along the fiber tracts and its dynamics over time. By factoring in the location and orientation of the coil, specific results for a patient or a case can be obtained. (Journal of Neural Engineering)

Company Says the FDA Has Approved Its Processor to Wirelessly Stream Audio to Hearing Prosthesis

March 14, 2016 - Cochlear announced the FDA approved the company's sound processor that uses wireless technology for users to stream audio directly to their device. The device is intended for people who have higher degrees of mixed-hearing loss. (FDA News)

Executive Details His Company's Vision of Bioelectronic Medicine

March 12, 2016 - In an interview, GlaxoSmithKline executive Moncef Slaoui said their bioelectronics initiative seeks wirelessly powered peripheral nerve stimulators that can interface with a single nerve and might one day be implanted laproscoptically in a matter of minutes. The initiative was presented at the SXSW Interactive technology conference in Austin, TX at a session called "Inner Space: Bioelectronics and Medicine's Future". (IEEE Spectrum)

Researchers Explore Use of Transcranial Direct Current Stimulation in Aphasia Therapy

March 10, 2016 - Two speech-language pathologist who teach at the University of Wisconsin-River Falls have begun gathering feasibility data in a pilot clinical study that involves sessions of transcranial direct current stimulation followed by rehabilitation training for post-stroke aphasia. They have been using facilities at the University of Minnesota, and are seeking more trial participants prior to filing a grant proposal for a larger study. (River Falls Journal)

Paper Raises Issue of Guidance for Neuromodulation Implant Patients During Other Surgeries

Feb. 15, 2016 - International Neuromodulation Society member Ramsis Ghaly, MD, is first author on a paper that asks, "Do we need to establish guidelines for patients with neuromodulation implantable devices, including spinal cord stimulators undergoing nonspinal surgeries?" The article gives case reports of two patients who have spinal cord stimulator implants and either underwent a hysterectomy or a hip replacement. The implant manufacturers' representatives were contacted pre-surgery. With provisions made to avoid electrical conductance of the device during cautery, the procedures went without complication. (Surgical Neurology International)

Faculty Collaborate on On-Demand Deep Brain Stimulation System

March 8, 2016 - A profile of Daniela Tuninetti, an associate professor of electrical and computer engineering at the University of Illinois at Chicago (UIC), reports that she is collaborating with International Neuromodulation Society member Konstantin Slavin, MD, and UIC engineering professor Daniel Graupe in developing an on-demand system for deep brain stimulation. The system is being designed to identify and prevent onset of tremor. Tuninetti was quoted as saying that advantages include longer battery life and decreased side effects, such as speech issues. She added that the technology is envisioned to have broader applications beyond tremor disorders. (University of Illinois at Chicago)

Article Recounts a Patient's Experience with Deep Brain Stimulation for Tremor

March 7, 2016 - International Neuromodulation Society member Paul Eldridge, a neurosurgeon at Walton Centre NHS Foundation Trust, was quoted in an article about the benefits a woman experienced after receiving deep brain stimulation for her essential tremor. The article stated, " 'On the whole this is an extremely effective and safe surgical procedure,' says Professor Eldridge. 'You can expect it to provide significant relief to 90 per cent of patients.' " (Daily Mail)

Australian Research Institute Eyes Forming a Neural Bioengineering Center

March 7, 2016 - Queensland Brain Institute plans to open a new Centre for Neural Bioengineering next year to investigate ways to deliver deep brain stimulation without invasive surgery to potentially treat conditions such as Parkinson’s disease, obsessive compulsive disorder, epilepsy and anorexia. A new biobank is also planned. One researcher at the institute is carrying out preclinical studies of ultrasound as a potential Alzheimer's disease treatment. (The Courier-Mail)

Case Report: Bipolar Patient Resumed Vagus Nerve Stimulation Following End-of-Battery Life Relapse

March 7, 2016 - A case report about a bipolar patient who remained in stable remission for nine years  after 20 months of vagus nerve stimulation therapy says the patient relapsed after the therapy was not re-initiated for several months after the battery died. Once the device was replaced, the patient regained remission after 17 months. "If the device malfunctions," the authors advise, "urgent surgical replacement is warranted with subsequent rapid titration to previous parameters as tolerated. Several months’ delay may trigger relapse and prove difficult to re-establish remission."  (BMJ Case Reports)

Company Receives FDA Approval for MRI-Safe Stimulation Leads

March 3, 2016 - Medtronic plc announced it has received FDA approval of its spinal cord stimulation leads that are designed for MRI compatibility. The company expects to begin marketing them later this month. (Mass Device)

Researchers Investigate Thalamic Stimulation in Treatment-Refractory Tourette Syndrome

March 3, 2016 - International Neuromodulation Society member Veerle Visser-Vandewalle and colleagues report a prospective case series of eight patients with treatment-refractory Tourette syndrome. The patients received high-frequency deep brain stimulation of the ventral anterior and ventrolateral motor part of the thalamus. The researchers found at six and 12 months' followup that the patients' motor tics were improved and their emotional state stabilized, they report in Biological Psychiatry. (Alpha Galileo)

News Weekly Ponders Cognitive-Enhancement Concerns

March 3, 2016 - An editorial and an Outlook article in Nature raise the issues posed by consumer interest in non-invasive brain stimulation for cognitive enhancement. (Nature)

Opinion Piece Forecasts Path for Further Technological Development of Neuromodulation

March 2, 2016 - Cambridge Associates cites cost savings and quality-of-life enhancements offered by neuromodulation therapy, using as an example data presented at the International Neuromodulation Society's 12th World Congress about reductions in healthcare costs among chronic pain patients who received spinal cord stimulation through a Western Canada health authority. The article calls for pursuing better insight into disease mechanisms and integration of technical capabilities to make smaller, more easily accessible devices to fulfill the promise of neuromodulation therapy. (Medical Device and Diagnostic Industry)

Visual Prosthetics Maker Garners $28.2 Million in Investment

March 2, 2016 - Retina Implant of Reutlingen, Germany said it has raised $28.2 million for further commercialization of its subretinal microchip to treat retinitis pigmentosa. The device received CE Mark in 2013 and won reimbursement in Germany in 2014. (Mass Device)

Article Describes Pursuit of Peripheral-Nerve-Stimulating Bioelectronic Therapies

March 2, 2016 - An article says GlaxoSmithKline has established a network of about 50 research collaborations in bioelectronic medicine, and most research is still at a preclinical stage. The article explains that bioelectronic medicine strives to read and correct signals in the peripheral nervous system to treat diseases such as inflammatory bowel disease, arthritis, asthma, hypertension and diabetes. The article adds that the National Institutes of Health has established a $248 million research-investment program, Stimulating Peripheral Activity to Relieve Conditions (SPARC). https://commonfund.nih.gov/sparc/grants (Financial Times)

Neuromodulation Activity Adds to Bottom Line for Company

March 1, 2016 - An analyst report says Greatbatch, Inc.'s cardiac/neuromodulation sales in the fourth quarter grew 44.5%, primarily driven by a neuromodulation product launch. Overall, the company reported adjusted gross earnings of 92 cents a share in the fourth quarter, and an 87.1% increase in sales from the previous year, totaling $317.6 million. (Zacks)

Funding Agency Seeks Applicants to Carry Out Pre-clinical Tests in New Peripheral-Nerve-Stimulation Indications

March 1, 2016 - The National Institutes of Health announced a funding opportunity as part of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) program. Investigators are invited to propose conducting pre-clinical tests of existing neuromodulation devices, from SPARC’s industry partners, in support of new market indications. The pre-clinical data that emerge are expected to generate the necessary safety and efficacy evidence to support an Investigational Device Exemption submission for a later pilot clinical study. A required letter of intent is due April 2, 2016 and the application is due May 2, 2016. (NIH)

Study Suggests Brain-Hemisphere Dominance May Influence Stimulation Effects

Feb. 29, 2016 - An abstract presented at the annual meeting of the American Association for the Advancement of Science suggests that noninvasive brain-stimulation treatments for depression should be tailored to the dominant hemisphere of the patient, as reflected in their handedness. In the research, 25 subjects who do not have depression were randomized to receive transcranial direct current stimulation (tDCS) to either the right or left side of the head. The subjects had a spectrum of hand preference, with four strongly preferring to use their left hand. After five days of tDCS sessions,  tDCS to the left hemisphere -- the typical approach -- resulted in right-handers feeling better and left-handers feeling worse, while the reverse was true for stimulation of the right hemisphere, according to the article. (Science)

Review Surveys Emerging Neurostimulation Options for Upper-Extremity Neuropathic Pain

Feb. 1, 2016 - Clinical Pain Advisor summarized a review in Hand Clinics that surveys emerging neurostimulation options for treatment of upper-extremity neuropathic pain. The journal article was authored by International Neuromodulation Society members Jason Pope, MD; David Provenzano, MD; Porter McRoberts, MD; and Timothy Deer, MD. (Clinical Pain Advisor)

Longer Delay in Start of Spinal Cord Stimulation is Linked to Higher Healthcare Utilization

Feb. 29, 2016 - International Neuromodulation Society members Shivanand P. Lad MD, PhD; Alexander R. Kent; Peter Staats MD; and Ashwini Sharan MD and colleagues analyzed Medicare claims data from 2008- 2013 over 12 months post-implant in 762 chronic pain patients. Looking at time-to-implant, the authors found that for every one-year delay in receiving a spinal cord stimulator, the odds increased that patients would fall into a high medical expenditures group (33%), receive high opioid prescriptions (39%), and have a higher number of office visits and hospitalizations (44% and 55%). (Neuromodulation: Technology at the Neural Interface)

Researchers Assess White-Matter Modulation During Deep Brain Stimulation in Parkinson's Disease

Feb. 26, 2016 - In 22 Parkinson's disease patients who received bilateral deep brain stimulation of the subthalamic nucleus, an analysis suggests that favorable clinical outcomes are associated with the modulation of white matter tracts directed to the superior frontal gyrus and the thalamus. The researchers say their method using probabilistic tractography with diffusion-tensor data may aid deep brain stimulation programming. (Brain)

Earnings Report Shows Growth in Neuromodulation Revenue

Feb. 24, 2016 - LivaNova, PLC announced 2015 annual financial results and fourth-quarter results. For the twelve months ended December 31, 2015, worldwide sales were $1.2 billion. In neuromodulation, growth was primarily driven by launch of the company's vagus nerve stimulation system in the U.S. in June 2015, and continued sales in international markets. In the fourth quarter, neuromodulation sales were $92 million, an increase of 25.9% on a constant currency basis. The company said it expects growth in neuromodulation in 2016 to be between 9% and 11%. (Globe Newswire)

Article: More Patients Are Being Offered Neuromodulation for Chronic Neuropathic and Ischemic Pain

Feb. 24, 2015 - An article about spinal cord stimulation options says that technological advances, and guidelines of the Neuromodulation Appropriateness Consensus Committee, have opened the door to more patients, with the therapy being considered earlier than as a last resort, prior to long-acting and strong opioid medications, leading to a better success rate. (Herald and Review)

Conference Presentation Analyzes Effects of Obesity, Smoking on Spinal Cord Stimulation Outcomes

Feb. 21, 2016 - In a retrospective analysis of 64 patients who received spinal cord stimulation (SCS) between January 2013 - July 2014, neither obesity nor smoking appeared to affect the efficacy of SCS or the infection rate. However, smokers had a 22.2% rate of lead migration, compared to 2.1% in the non-smokers. The study was presented at the American Academy of Pain Medicine Annual Meeting. International Neuromodulation Society President Timothy Deer, MD, who was not involved in the study, was quoted as commenting that there would need to be more patients in order to see a statistical difference. (Medscape)

Startup Peripheral Nerve Stimulation Company Raises Capital

Feb. 18, 2016 - A startup company spun out of Stanford University has raised $18 million from Google Ventures, Johnson & Johnson Development Corporation, Lux Capital, Action Potential Venture Capital, DRX Capital and Lightstone Ventures, according to the Silicon Valley Business Journal. The company, Cala Health, has a 2014 patent application for a peripheral nerve stimulator to control tremor. (MobiHealthNews)

Overview Summarizes Ongoing Clinical Trials of Vagus Nerve Stimulation for Migraine

Feb. 22, 2016 - ElectroCore has expanded from studying noninvasive vagus nerve stimulation (VNS) in cluster headache. In Europe, the company is now conducting two randomized, double-blind, parallel-group, sham-controlled studies of noninvasive VNS in migraine. One multi-center study on the prevention of migraines attacks has enrolled more than 200 of up to 400 patients. A second study enrolled the first of up to 250 patients at 10 sites in Italy to investigate noninvasive VNS as an acute treatment to reduce pain in migraine attacks. (Life Scientist)

Healthcare Chain Now Offers Spinal Cord Stimulation Services in Qatar

Feb. 21, 2016 - A network of 12 pain management clinics in Qatar began offering spinal cord stimulation therapy in August 2015. (The Peninsula)

Dorsal Root Ganglion Stimulation is Approved in the U.S. for Complex Regional Pain Syndrome Therapy

Feb. 17, 2016 - St. Jude Medical received FDA premarket approval for its dorsal root ganglion neurostimulation system. The device is designed to treat chronic intractable lower-limb pain in adults who have complex regional pain syndrome. (Modern Healthcare)

Company Receives Broadened FDA Approval for Use of Its Deep Brain Stimulation System in Parkinson's Disease

Feb. 17, 2016 - Medtronic plc received a broader FDA approval for its deep brain stimulation (DBS) system. The system is now approved for patients who have had Parkinson's disease for at least four years, with recent onset of motor symptoms, or who have had longstanding motor complications not adequately controlled by medication. (Fierce Medical Devices)

Pharmaceutical Company Partners with Neurostimulation Device Maker

Feb. 16, 2016 - GlaxoSmithKline has partnered with Nuviant Medical to use its neurostimulation implant systems as a research platform for clinical applications of bioelectronics medicine. Bioelectronics, the company specified, seeks to develop miniaturized implants to interface with the peripheral nervous system to modulate organ function in order to treat chronic disease. (Fierce Medical Devices)

Researcher: Electrical Brain Stimulation May Aid Therapy for Progressive Aphasia

Feb. 14, 2016 - A researcher is investigating transcranial direct current stimulation as an adjunct to speech therapy in primary progressive aphasia. She presented preliminary results involving 19 patients at the annual meeting of the American Association for the Advancement of Science. (Star Tribune)

Article Weighs Cost-Effectiveness of Repetitive Transcranial Magnetic Stimulation

Feb. 12, 2016 - In a "Wise Buy" column, a writer looks at costs of repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant depression compared to electroconvulsive therapy. The article says an analysis showed that the cost of achieving one quality adjusted life year was $36,000, and anything less than $50,000 is considered cost-effective. (MedPage Today)

Authors Look at the Future of Flexible Electrodes in Neuroscience Applications

Feb. 11, 2016 - A team of co-authors reviews advances in implantable electrodes based upon soft materials, and their applications in neuroprosthetics, neural signal recording, and neuromodulation. (Lab on a Chip)

Company Raises Financing for "Neuropriming" Development

Feb. 10, 2016 - Halo Neuroscience announced it has raised $9 million in Series A financing and is pursuing both stroke rehabilitation and athletics with its headphones that are designed to provide brain stimulation to the motor cortex, an effect the company calls neuropriming. (Med City News)

Researchers Demonstrate an Intravenous Brain-Machine Interface in Sheep, Say the Minimally Invasive Interface May Help Guide an Exoskeleton for Spine-Injury Patients

Feb. 10, 2016 - Australian researchers have published a preclinical demonstration of a minimally invasive, paperclip-sized brain machine interface comprised of an electrode-bearing stent, introduced into a vein to lie alongside the motor cortex. Their paper in Nature Biotechnology describes their experience taking neural recordings for up to six months in sheep. The project, funded by the U.S. Defense Advanced Projects Research Agency, may allow spine-injured patients to control an exoskeleton, or aid mobility of stroke patients. A clinical trial in three patients is planned next year in Victoria, Australia. Goals of the project are described by one team member in a column in The Conversation. (IEEE Spectrum)

External Vagus Nerve Stimulation to Be Tested for Controlling Obesity

Feb. 9, 2016 - An external vagus nerve stimulation system, the NeuroCoach II Stim, will be subject to a placebo-controlled clinical trial for 50 patients in France to potentially help control obesity. The device clips on the ear, and its potential to address obesity was discovered by chance after it was noticed that patients using the stimulation to treat other conditions lost weight. (Daily Mail)

Article Describes Locally Available Pain Interventions

Feb. 8, 2016 - International Neuromodulation Society (INS) member Jason Pope, MD, was featured along with INS member Michael Yang, MD, in a newspaper article about the latest pain interventions being available in the Santa Rosa, CA area -- including high frequency spinal cord stimulation. (Press Democrat)

Company Eyes Commercialization of Implantable Therapy for Chronic Low Back Pain.

Feb. 8, 2016 - Mainstay Medical International plc announced 2015 preliminary results and a business update. The Dublin-based company said it awaits CE marking and is preparing to commercialize its implantable device for chronic low back pain in Europe, with the first target market located in Germany. Meanwhile, the company received two more U.S. patents, bringing the total number to seven, and is currently preparing for an international prospective randomized sham-controlled blinded clinical trial, to include sites in the U.S. (Business Wire)

Newspaper Profiles a Local Epilepsy Patient Who Received a Neurostimulation Implant

Feb. 6, 2016 - An article about a young man who received a responsive neurostimulation system to treat medication-resistant epilepsy quotes International Neuromodulation Society members Ali Rezai, MD, and Konstantin Slavin, MD about the field of electrical brain stimulation therapy. (Journal Sentinel)

Researchers Say Transcutaneous Vagus Nerve Stimulation May Hold Promise for Helping Treat Depression

Feb. 4, 2016 - Researchers from the China Academy of Chinese Medical Sciences and Harvard Medical school investigated the effects of transcutaneous vagus nerve stimulation in 34 patients with depression, who received either sham or active stimulation for a month. The results, in Biological Psychiatry, showed the active-stimulation group experienced symptom improvement. Neuroimaging before and after indicated increased functional connectivity between the default mode network and precuneus and orbital prefrontal cortex, a network that is known to be altered in depression. The authors conclude that the non-invasive, safe and low cost method shows potential promise as a possible treatment option, if efficacy is sustained. (EurekAlert)

Review Considers Current Development of Spinal Cord Neuromodulation for Heart Disease

Feb. 4, 2016 - International Neuromodulation Society member Jeffrey Ardell, PhD has published a review about heart failure and mechanisms of spinal cord neuromodulation for heart disease. The article says safety concerns for bioelectrical treatment of heart failure with reduced ejection fraction have been addressed, but optimization of spinal cord stimulation delivery remains a concern. (Nature Reviews Cardiology)

Companies Announce Plans for Directional Deep Brain Stimulation

Feb. 1, 2016 - Aleva Neurotherapeutics announced a strategic development, supply, and manufacturing relationship with the Greatbatch, Inc. subsidiary Greatbatch Ltd. Aleva will license a neurostimulation platform for the field of use of deep brain stimulation for treatment of Parkinson’s disease and essential tremor. Aleva will incorporate its own proprietary electrode technology for directional deep brain stimulation (DBS) along with the in-licensed technology for a 24-channel neurostimulator and related programmers. Aleva is raising a Series C round of financing, led by Greatbatch, for completing a chronic study in 60 Parkinson's disease patients, and to support seeking CE Mark approval for the directional DBS system. Additionally, Greatbatch said it expects to be renamed Integer Holdings Corporation later this year, following its October 2015 acquisition of Lake Region Medical. (GlobeNewswire)

Article Explains Goal of Using Implant to Stabilize Back and Relieve Chronic Pain

Jan. 31, 2016 - Dublin-based Mainstay Medical has applied for CE Mark approval of a novel investigational neurostimulation device for back pain. The implant induces contractions of the multifidus muscle to stabilize the back. The company would like to offer the device later this year in Europe as an option when treatments such as physiotherapy have failed. An article says the application includes data from a clinical trial involving 45 patients in Belgium, Australia, and England. The coverage mentions International Neuromodulation Society member Sam Eldabe, MBBS, FRCA of Middlesbrough, England, who implanted four enrollees. (Daily Mail)

Neurostimulation for Spine-Injury Patients Receives Research Funding in Minnesota

Jan. 28, 2016 - The state of Minnesota has given a grant to the University of Minnesota and Hennepin County Medical Center to study epidural spinal cord stimulation as a way to potentially restore some function in spine-injured patients. A summary in Becker Spine Review says clinical trials in other states resulted in patients moving paralyzed muscles and that once the stimulator has been implanted for some time, the patients should experience some improved function even when it is inactive. (WCCO)

Study: External Device Improved Post Traumatic Stress Disorder Symptoms

Jan. 28, 2016 - A proof-of-concept clinical trial of adjunctive treatment with external trigeminal nerve stimulation in 12 patients who have post traumatic stress disorder (PTSD) and major depressive disorder showed that eight weeks of nightly stimulation led to significant improvements in symptom severity. The research institution, the University of California, Los Angeles, is seeking military veterans with PTSD for additional clinical research with the modality. (Neuromodulation: Technology at the Neural Interface)

Agency Seeks Proposals for Neural Interface Technology

Jan. 26, 2016 - The U.S. Defense Advanced Research Projects Agency (DARPA) announced a Neural Engineering System Design program, and invites proposals for modular, compact hardware that can record from more than 1 million neurons and stimulate more than 100,000 neurons. (TechNewsWorld)

Analysis Compares Healthcare Utilization and Payments for Cancer-Pain Patients Who Receive Intrathecal Drug Delivery or Conventional Medical Management

Jan. 27, 2016 - Healthcare costs of conventional medical management vs. intrathecal drug delivery (IDD) were compared in 73 matched pairs of patients who had cancer-related pain. In the first year after IDD implant, the IDD patients had a consistent trend of lower medical utilization, and total payments were $3,195 mower. The analysis by International Neuromodulation Society member Lisa Stearns, MD and colleagues suggests that despite the high initial cost of IDD, those patients incur lower medical utilization and payments over the first year post-implant. (Neuromodulation: Technology at the Neural Interface)

Media Cover Use of Deep Brain Stimulation for Focal Hand Disorder

Jan. 27, 2016 - A Chinese citizen with focal hand disorder was reported to receive deep brain stimulation (DBS) surgery while playing guitar, which he had had to give up due to his condition. His surgeon said this was the seventh known case where DBS was used for this disorder, a condition that was said to not be uncommon among athletes and musicians. The article described DBS therapy, noting that "it is thought that it will remain the main surgical therapy for Parkinson's for the next 30 years." (Daily Mail)

European Researchers Examine Neuroendocrine Changes in Deep Brain Stimulation for Obsessive Compulsive Disorder

Jan. 26, 2016 - Researchers report that resuming deep brain stimulation (DBS) in patients with treatment-resistant obsessive compulsive disorder led to rapid release of the neuroendocrine factors prolactin and thyroid-stimulating hormone (TSH). The authors say the findings suggest that DBS is capable of inducing rapid psychiatric symptom changes through an alternative or additional underlying mechanism. For instance, seeing the increase in prolactin and TSH leads them to believe the observed acute mood elevation may be due to stimulation of hypothalamic thyrotropin-releasing hormone. They add that one patient who had previously become a DBS non-responder found some relief of his affective symptoms during the day by switching the DBS off at night and resuming it in the morning, thereby recreating a short-term acute stimulation effect. (Nature Translational Psychiatry)

Company Looks to Gain More Capital for Its Visual Prosthesis Pipeline

Jan. 25, 2016 - Second Sight Medical Products, Inc. filed a proposed rights offering with the Securities and Exchange Commission for its existing companies. The company would use the proceeds for an ongoing safety and efficacy trial of its Argus® II Retinal Prosthesis System for the treatment of age-related macular degeneration and development of a visual cortical prosthesis to potentially treat nearly all forms of blindness. (Business Wire)

Pharmacy Publication Features Bioelectronic Medicine

January 2016 - An article about bioelectronic medicine defines it as "the use of neurostimulation to modulate disease pathways." For now, the article says, vagus nerve stimulation is receiving the most attention for potentially treating disease conditions. (PharmaTimes)

Researchers Publish Results of Prospective Peripheral Nerve Stimulation Clinical Trial

Jan. 22, 2016 - International Neuromodulation Society members Timothy Deer, MD; Jason Pope, MD; Ramsin Benyamin, MD; Richardo Vallejo, MD, PhD; David Caraway, MD, PhD; Peter Staats, MD; Eric Grigsby, MD; Porter McRoberts, MD; Tory McJunkin, MD; Robert Levy, MD; Leonardo Kapural, MD, PhD; and Nagy Mekhail, MD, PhD and colleagues have published Early View results of a partial crossover trial of a novel peripheral nerve stimulation device. They conclude the implantable device is safe and effective for treating neuropathic pain of peripheral nerve origin. In the safety and efficacy trial, 94 patients were randomized in control and active stimulation groups. The results showed that three months of active stimulation led to a 38% response rate (vs. 10% in the control group); and the mean pain reduction in the treatment group was 27.2% vs. 2.3% in the control group. (Neuromodulation: Technology at the Neural Interface) 

Hospital in India Announces Implantation of a Vagus Nerve Stimulation System in a Patient with Heart Failure

Jan. 20, 2016 - A cardiac care hospital in India has implanted a vagus nerve stimulation system in a patient who has heart failure, in an effort to increase tone of the parasympathetic nervous system and improve her symptoms. (Equity Bulls)

Review Evaluates Evidence for Spinal Cord Stimulation

January 2016 - International Neuromodulation Society members Jay Grider, DO, PhD; Laxmaiah Manchikanti, MD; Alexios Carayannopoulos, DO, MPH; Carl Balog, MD; Michael E. Harned, MD; Salim M. Hayek, MD, PhD; Ricardo Vallejo, MD, PhD; and Paul Christo, MD, along with other co-authors, have published a systematic review of spinal cord stimulation (SCS) in spinal pain. They found there was significant evidence -- Level I to II -- of the efficacy of SCS in lower-back failed back surgery syndrome. In addition, they found moderate Level II to III evidence for the efficacy of high frequency stimulation based on one randomized controlled clinical trial. They conclude more studies are needed and said that based on a lack of high quality studies, there was limited evidence for adaptive stimulation and burst stimulation. (Pain Physician)

Observational Study Suggests Percutaneous Electrical Nerve Stimulation is Effective and Feasible in Neuropathic Pain

January 2016 - International Neuromodulation Society members Giuliano De Carolis, MD; Goffredo Liberatoscioli, MD; Paola Nosella, MD; and Luigi F. Nardi, MD and co-authors published results of a multi-center observational study of percutaneous electrical nerve stimulation (PENS) in neuropathic pain. There were 76 patients who had a variety of conditions, such as post-herpetic pain and occipital neuralgia. The authors concluded that the intervention produced significant pain relief and is safe and feasible. (Pain Physician)

Study Shows Headache Reduction from Non-invasive Vagus Nerve Stimulation

Jan. 19, 2016 - International Neuromodulation Society member Thomas Kinfe and colleagues published data in the Journal of Headache and Pain that showed cervical non-invasive vagus nerve stimulation twice daily reduced the number of headache days per month from 14.7 to 8.9, and the number of monthly migraine attacks from 7.3 to 4.5. (Business Wire)

Analysis Finds Spinal Cord Stimulation Lowers Amputation Rate in Chronic Critical Limb Ischemia

Jan. 18, 2016 - A meta-analysis of 13 studies comprising 595 patients concludes that spinal cord stimulation is better than medical management alone in preventing limb amputation for patients who have chronic critical limb ischemia, particularly in patients with less severe disease. The findings were presented in a poster at the Annual Pain Medicine Meeting of the American Society of Regional Anesthesia and Pain Medicine. (Pain Medicine)

Authors Present an Overview for Pharmacists of Medical and Surgical Treatment for Parkinson's Disease

Jan. 18, 2016 - An article summarizes Parkinson's disease treatment and informs pharmacists they may see a Parkinson's patient more often after deep brain stimulation surgery, as medication dosages are adjusted. (Pharmacy Times)

Non-invasive Stimulation for Fibromyalgia Studied

Jan. 17, 2016 - A Phase II open-label study of high-definition transcranial direct current stimulation in 14 fibromyalgia patients, published in the Journal of Pain, explored dosing regimens for pain reduction. (National Pain Report)

Column Presents Transcranial Magnetic Stimulation Options for Depression

Jan. 17, 2016 - An article about transcranial magnetic stimulation (TMS) for depression describes deep TMS as a newer option for treatment-resistant depression. (New York Daily News)

Pair Exhibit a Consumer Device in Development for Vagus Nerve Stimulation through Earbuds

Jan. 15, 2016 - International Neuromodulation Society member Daniel Cartledge, MD, and his brother, a cardiac and thoracic surgeon, have co-developed a vagus nerve stimulation device that was voted a top new digital health device at the Consumer Electronics Show. The product is an earbud device designed to be used with music and improve mood, although the product has no medical claims. The device is expected to enter the market in the next few months. (Palm Beach Post)

Column Asks If More Will Be Done For Patients in a Minimally Conscious State

Jan. 14, 2016 - A newspaper column mentions motor cortex stimulation and describes the ability to distinguish and partially rehabilitate patients who are in a minimally conscious state in which they retain some awareness and ability to respond. The writer asks if society will more fully restore the lives of people who may currently only receive custodial care. (Houston Chronicle)

Company Announces New Head of Neuromodulation Business Unit

Jan. 14, 20i6 - LivaNova, PLC has named former Cyberonics, Inc. executive Jason Richey president of LivaNova's neuromodulation business unit and a member of the executive team. He was previously vice president of global sales and marketing for neuromodulation. (Street Insider)

Device Maker Announces Sales Growth

Jan. 13, 2016 - St. Jude Medical, Inc. expected to report consolidated net sales of approximately $1.447 billion for the fourth quarter of 2015. That is an increase of 7% on a constant currency basis. Sales of its neuromodulation products in the fourth quarter amounted to approximately $128 million, an increase of 9% on a constant currency basis over the fourth quarter of 2014. (Business Wire)

Vagus Nerve Stimulation System Developer Raises $11 Million

Jan. 13, 2016 - Minnesota-based EnteroMedics Inc. brought in $11 million in the 2nd tranche of a $25 million offering, announced in November, of senior amortizing convertible notes. The company received $1.5 million at the initial offering in November 2015. In 45 days, a 3rd tranche of $12.5 million is scheduled. The company has developed a vagus nerve stimulation system to treat metabolic diseases and other gastrointestinal disorders. (Mass Device)

Company Describes Pursuing a Potentially Therapeutic Brain-Stimulation Headset

Jan. 13, 2016 - A U.K. company founded in 2014, Cerestim, says it has demonstrated a proof-of-concept for an alternating transcranial direct-current stimulation device to be remotely monitored by physicians. The company is initially targeting the product for depression and pending regulatory approval, would expect to market the home-use device in three to five years. An article explains that the headset is intended to identify dysfunctional neural activity and reset that through stimulation via electrodes tailored for each individual. (International Business Times)

Singapore Initiative is Working to Create a Wireless Neurostimulator

Jan. 13, 2016 - An initiative in Singapore is developing a wireless implantable chronic pain management device that is anticipated to be about as small as a grain of rice. The neurostimulator is being developed by the Institute of Microelectronics of the Agency for Science, Technology and Research (A*STAR) and the local biotechnology firm Biospark Technologies. (Today Online)

Patient Enrollment is Complete in Tibial Nerve Stimulation Study

Jan. 11, 2016 - Israel-based BlueWind Medical announced it has completed enrollment of 36 patients with overactive bladder in a clinical trial of its wireless neurostimulation device. The patients in the U.K. and Netherlands will have the device implanted in their lower leg to stimulate the tibial nerve. The company expects to present initial results in February 2016, and is gathering the data to support a CE Mark application. (PR Newswire) 

Research Indicates Non-Invasive Stimulation Can Potentially Help Suppress Migraine Onset

Jan. 11, 2016 - In preclinical studies reported in Pain non-invasive vagus nerve stimulation (VNS) was found as effective as surgically implanted VNS in suppressing, by up to 40%, cortical spreading depression that is associated with pre-migraine aura. (PR Rocket)

Reprogramming Helped Restore Efficacy of Spinal Cord Stimulation

Jan. 8, 2016 - At the combined annual scientific meeting in London of the Neuromodulation Society of the United Kingdom and Ireland and the International Neuromodulation Society (INS) chapters from Germany and Switzerland, INS member Frank Wille, MD presented results gathered between 2010 - 2011 in the Netherlands that showed that reprogramming existing spinal cord stimulation (SCS) devices could restore efficacy in managing back pain. He said that in this high-density mode, the leads were implanted as close as possible to the T9 - T10 target, and the devices were operated at maximum frequency, with the pulse width as broad as possible and amplitude adjusted for continuous stimulation. Rather than have devices explanted, 65% of the patients continued to use their SCS systems one year later. (NeuroNews)

Neurostimulation Device Maker Receives Regional Government Grant in Belgium

Jan. 8, 2016 - Neurostimulation device maker Nuviant Medical received a research grant of €3.4 million from the Walloon Region government and plans to expand manufacturing operations there in a program that incorporates digital healthcare in collaboration with regional innovators. (Fierce Medical Devices)

Researchers Report Long-term Data on Deep Brain Stimulation in Dystonia

Jan. 8, 2016 - A group of Korean researchers published long-term data on 36 patients with several types of dystonia that compares outcomes of deep brain stimulation to the globus pallidus interna. Their results suggest a favorable outcome is expected for patients with DYT-1 dystonia and isolated dystonia without a known genetic cause. (PLoS ONE)

Optogenetics Study Examines Role of Hippocampus in Social Memory

Jan. 5, 2016 - Laboratory researchers used optogenetics in mice to excite a part of the hippocampus involved in memory formation and found the stimulation enhanced social memory if applied during memory formation, but not during retrieval. (Molecular Psychiatry)

Post-Market Surveillance: External Trigeminal Nerve Stimulation Compliance Rate is Twice That of Medical Management for Chronic Migraine

Jan. 7, 2016 - CEFALY Technology released data about patient compliance among 14,745 migraine patients who acquired the Belgium-based company's trigeminal nerve stimulation device between March 2014 and October 2015. The external device was FDA-approved in March 2014 to reduce the frequency and intensity of migraines. Full compliance would entail replacing the electrode every month. Based on recurrent orders of electrodes, the company reported a 72.4% compliance rate, twice that of oral preventive migraine medication. (Fierce Medical Devices)

Company Sets Up Distribution Agreement in Germany for Non-Invasive Treatment for Chronic Headache

Jan. 6, 2016 - The pan-European pharmaceutical company Desitin, a distributor of treatments for Parkinson's disease and epilepsy, entered an agreement Jan. 1 to distribute ElectroCore's non-invasive vagus nerve stimulation device, gammaCore, to neurologists in Germany who treat migraine and cluster headache. (Business Wire)

Medical Society Plans Movement Disorders Registry in India

Jan. 5, 2016 - The Movement Disorders Society of India announced it is planning to create a registry of Parkinson's and movement disorder cases in the interests of optimizing treatment. Besides deep brain stimulation, the society is interested in potential novel treatments and planned a conference on Jan. 8 to discuss those. (Times of India)

Case Reports Detail Considerations for Intrathecal Drug Delivery

Jan. 1, 2016 - Since intrathecal drug delivery systems have been in use for more than two decades, the need to manage patients at the end of the device life is increasingly common, note International Neuromodulation Society members Jason Pope, MD and Timothy Deer, MD in a case report about a patient who experienced a decrease in analgesia and needed a replacement infusion pump. The authors also report about a novel delivery system for ziconotide, in a separate case report on Dec. 30, 2015. (Pain Medicine News)

Authors Examine Growth of Emerging Indications for Deep Brain Stimulation

Jan. 1, 2016 - There was rapid growth in the percentage of deep brain stimulation patients in the U.S. who were treated for indications under a humanitarian device exemption or other emerging indication in the last decade, according to analysis of hospital discharge records. The newer indications were associated with greater costs, so the authors of this study conclude that "additional costs should be anticipated as surgeons gain experience with new patient populations and targets." (Journal of Neurosurgery)

Last Updated on Saturday, July 09, 2016 02:34 AM
 
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