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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)

Review Examines Treatment Gap for Patients with Medication-Resistant Epilepsy

December 2015 - International Neuromodulation Society members Paul Boon, MD and Kensuke Kawai, MD, PhD joined colleagues in co-authoring a review about access to other treatments for patients who have drug-resistant epilepsy, including vagus nerve stimulation (VNS) and deep brain stimulation. They point out that education of patients and government payers in Japan helped raise awareness of the palliative benefits of VNS, which they say moved the technology from an orphan device status in the early 2000s to an approved status in 2010. There is currently an all-patient registry for people in Japan with epilepsy who are receiving VNS therapy, which shows 39% of patients achieved a seizure reduction of 50% or more. However, they add that a treatment gap continues, in which an estimated less than 1% of patients with drug-resistant epilepsy receive VNS treatment, although some two-thirds to three-quarters of patients with drug-resistant epilepsy are generally considered candidates for non-medical interventions. (European Neurological Review)

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)

Column Describes Company's Interest in Vagus Nerve Stimulation for Tinnitus and Stroke

Dec. 31, 2015 - Frank McEachern, the CEO of Dallas, TX-based MicroTransponder, Inc. was interviewed about the company's interest in potentially applying vagus nerve stimulation to treat tinnitus or aid stroke rehabilitation. (Med City News)

Local News Outlet Follows Up Patient Whose Surgery Was Televised

Dec. 29, 2015 - International Neuromodulation Society member Jonathan Miller, MD was quoted in an article about a Parkinson's disease patient whose deep brain stimulation surgery was televised live in October. The neurosurgeon said many patients expressed feeling more informed and less fearful after seeing what takes place during the procedure. (IndeOnline)

Specialists' Evaluation Appeared to Anticipate Risks in an Essential Tremor Cohort

Dec. 28, 2015 - International Neuromodulation Society member Daniel Martinez-Ramirez, MD and colleagues at the University of Florida in Gainesville published an analysis of deep brain stimulation screening in 44 patients with essential tremor that examined the rate of unintended hospitalization within a year of surgery. In the retrospective analysis, the authors found that surgical concerns raised by seven specialties during the interdisciplinary screening directly related to the degree of unintended hospitalizations. They reason that such evaluation may help anticipate risk of complications, although prospective comparative research would need to confirm the results. (PLoS One)

Authors Present a Case Report of Closed-Loop Spinal Cord Stimulation for Neuropathic Pain

December 2015 - International Neuromodulation Society members Marc Russo, MBBS,DA (UK), FANZCA, FFPMANZCA, Timothy Deer, MD, and Jason Pope, MD co-authored a case report about a spinal cord stimulation patient who could not tolerate changes in stimulation due to positional changes. The patient enrolled in a clinical trial of a closed-loop system and has been satisfied with that pain relief method. The authors say continued research may demonstrate that feedback-loop control of paresthesia can provide a more constant therapeutic effect. (Pain Medicine News)

Burst-Mode Spinal Cord Stimulation Described in Case Report

December 2015 - International Neuromodulation Society members Ganesan Baranidharan, MD, Timothy Deer, MD, and Jason Pope, MD about a man with refractory peripheral neuropathic pain whose replacement pulse generator for his spinal cord stimulator allowed switching to burst stimulation. The man had less pain and more mobility. While he had been used to paresthesia, reprogramming of the new device eliminated unpleasant stimulation effects. The authors conclude "electrical dosing may be the key to further understanding the best methods of delivery of neuromodulation going forward." (Pain Medicine News)

Two Cases Presented of Pain Management in Limbs from Dorsal Root Ganglion Stimulation

December 2015 - International Neuromodulation Society members Timothy Deer, MD, Ganesan Baranidharan, MD, Jason Pope, MD, and Marc Russo, MBBS,DA (UK), FANZCA, FFPMANZCA present two cases of patients with chronic foot or arm pain. The patients were treated with unilateral stimulation of the dorsal root ganglion (DRG). At 6 - 12 months followup, they reported significant pain reduction. The authors report that DRG stimulation is approved in Europe and Australia and they anticipate a request for FDA approval based on findings from a prospective, randomized clinical trial that compared DRG stimulation to spinal cord stimulation. Meanwhile, they add, "additional studies are planned for DRG of the cervical and thoracic spine and new waveforms and frequencies on the DRG target." (Pain Medicine News)

Publication Profiles the International Neuromodulation Society President

Dec. 23, 2015 - International Neuromodulation Society President Timothy Deer, MD, was profiled in the December issue of NeuroNews. He spoke about the importance of research in improving outcomes and function and lowering costs of care. He also spoke about an evolution in technical capabilities so that patients may have more than one option from a single spinal cord stimulation device. (NeuroNews)

Authors Advise Primary Care Doctors When to Refer Patients for Spinal Cord Stimulation

December 2015 - An article advising primary care providers when to refer patients to spinal cord stimulation states that timely referral can have substantial effects on outcomes in appropriate candidates, and mentions indications in which it has been shown to be superior to conservative medical management or reoperation, has demonstrated clinical benefit, and been shown to be cost-effective. The indications cited are failed back surgery syndrome, complex regional pain syndrome, limb ischemia, and refractory angina pectoris. The article provides an efficacy table and a suggested treatment algorithm for certain types of back pain. The accompanying commentary summarizes peer-review papers by a number of International Neuromodulation Society members, and mentions authors Krishna Kumar, MD; Sam Eldabe, MD; Richard North, MD; Konstantin Slavin, MD; Rod Turner, PhD; and Nagy Mekhail, MD, PhD. (Pain Medicine News)

Company Raises Capital to Support a Clinical Trial of a Neuromodulation Device for Overactive Bladder

Dec. 21, 2015 - Axonics Modulation Technologies announced $38.5 million in Series B financing that it intends to use to support a clinical trial next year of its rechargeable sacral nerve stimulation system in patients with overactive bladder. The company has raised $59 million since it formed in 2013 to commercialize technology licensed from the Alfred E. Mann Foundation. (PE Hub Network)

Article: Deep Brain Stimulation to the Fornix is Feasible and Was Well-Tolerated in Study Subjects

Dec. 18, 2015 - An article documents the preoperative period in 46 patients with probable early Alzheimer's disease who received deep brain stimulation to the fornix during the 12-month ADvance clinical trial. The authors conclude that it is feasible to target this brain structure without directly injuring it, and the surgery was well-tolerated at 90 days. In 26 patients, there were 64 adverse events, seven serious, but no neurological deficits or deaths were reported. (Journal of Neurosurgery)

Company Plans Clinical Trial in France of Visual Prosthetic Device

Dec. 14, 2015 - Pixium Vision obtained regulatory approval to launch a clinical study in France of an epi-retinal implant designed to restore some vision in patients who have retinitis pigmentosa. This second-generation device has 150 electrodes. The company announced Dec. 21 it applied for CE Mark approval for the system. (Business Wire)

Researcher Explores Potential for Regulating Do-It-Yourself Brain Stimulation

Dec. 18, 2015 -  An MIT PhD student, Anna Wexler, has published two papers this fall in academic journals that have been noted by colleagues to encapsulate recent history and regulatory concerns about the do-it-yourself movement in transcranial direct current stimulation. She suggests that regulators should engage with the community to determine the extent of use and need for new guidelines, since as a practical matter, hobbyists are free to build their own devices. Meanwhile, she said there are "multiple, distinct" pathways in the U.S. where such devices might be regulated. For example, beyond the FDA, the U.S. Consumer Product Safety Commission and the Federal Trade Commission oversee regular consumer products' safety and advertising laws. Her papers appeared in the Journal of Medical Ethics and the Journal of Law and Biosciences (Bioscience Technology)

Funding Announcement Seeks Brain-Science Proposals

Dec. 18, 2015 - The National Institutes of Health is requesting applications for BRAIN Initiative funding to support projects that focus on tool development and mechanistic understanding of non-invasive neuromodulation techniques. An announcement notes that international organizations are welcome to apply. The application deadlines are in February and March 2016. (BRAIN Update)

Forum Focuses on Emerging Neurotechnology

December 2015 - The 15th annual Neurotech Leaders Forum in San Francisco in November featured regulators, funders, and entrepreneurs who discussed emerging technologies and the path to market. Speakers included the FDA's director of Neurological and Physical Medicine Devices, Carlos Pena, who described how FDA intends to decide investigational device exemption requests within 30 days, and other ways the agency is endeavoring to make its processes timely and effective. Other sessions focused on considerations for device security. (Neurotech Business Report)

Company Says Cohort Group Comparison Demonstrates Improvements from Newest Spinal Cord Stimulator

Dec. 16, 2015 - Data presented at the North American Neuromodulation Society meeting in December updated initial results from the long-term LUMINA spinal cord stimulation (SCS) study, initially shown at the International Neuromodulation Society 12th World Congress in June. Boston Scientific Corporation announced the data from four patient groups who were followed for up to 24 months demonstrate that the company's most-recent SCS system provides a 70% improvement in lower back pain relief compared to the previous-generation device. The latest system has 32 contacts and four lead ports, along with programming software that is based on three-dimensional modeling of spinal cords. (Med Device Online)

Study Indicates Non-invasive Optic Nerve Stimulation Can Improve Neuropathic Vision Loss

Dec. 14, 2015 - Data were presented at the North American Neuromodulation Society on a controlled clinical trial of transorbital optic nerve stimulation in patients with optic neuropathy that caused visual field loss. In the study, 45 patients received stimulation and 37 received placebo. The results indicate the stimulation group benefited from a significantly improved visual field compared to the control group, according to an announcement by EBS Technologies GmbH, which has received CE Mark approval to market the therapy in the European Union. (Sys-con.com)

Company Plans U.S. Clinical Trial of Percutaneous Stimulation in Chronic Migraine

Dec, 11, 2015 - StimRelieve LLC announced FDA investigational device exemption approval to begin a clinical trial of percutaneous, wirelessly powered neurostimulators to treat medically refractory chronic migraine. (Business Wire)

Long-Term Data Show Benefits of Dorsal Root Ganglion Stimulation for Pain Conditions

Dec. 11, 2015 - St. Jude Medical, Inc. announced long-term data presented in a plenary session at the North American Neuromodulation Society meeting show dorsal root ganglion stimulation provides sustained and superior pain relief over traditional spinal cord stimulation in patients with complex regional pain syndrome or peripheral causalgia.The data from the ACCURATE study confirm three-month primary endpoint data that was originally presented at the International Neuromodulation Society World Congress in June 2015. (Business Wire)

Study Results Presented Comparing Tonic and Burst Spinal Cord Stimulation

Dec. 11, 2015 - St. Jude Medical, Inc. announced the SUNBURST study has demonstrated that burst stimulation is superior to traditional tonic spinal cord stimulation in relieving chronic pain. The study results presented in a plenary session at the North American Neuromodulation Society meeting  showed patients preferred burst stimulation and most experienced less paresthesia or none. (Business Wire)

Vagus Nerve Stimulation Studied for Preventing Blood Flow After Trauma or Surgery

Dec. 10, 2015 - International Neuromodulation Society member Jared Huston, MD, PhD was scheduled to present data Doc. 12 at the North American Neuromodulation Society meeting that indicates vagus nerve stimulation is a potentially efficacious and safe way to stop bleeding and prevent hemorrhagic complications following surgery and other invasive procedures. (Blackbird)

Company Announces Mobile Application Partnership

Dec. 11, 2015 - Medtronic plc is expanding a partnership with Samsung Electronics America that began in june with smart devices for diabetes to now also develop Android mobile applications for neuromodulation devices. (Fierce Medical Devices)

Company Anticipates Medicare New Device Payment Specifications in January

Dec. 10, 2015 - Nevro Corp. announced the Centers for Medicare & Medicaid Services approved a transitional pass-through payment, under a new device category, for high frequency stimulation under the Medicare hospital outpatient prospective payment system to begin Jan. 1, 2016. (Street Insider)

Equipment Manufacturer Expands Access to Implantable Pulse Generator Platform Technology

Dec. 10, 2015 - Evergreen Medical Technologies, Inc. announced it is expanding product development services through access to AdvaStim's customizable, modular core electronic components for implantable pulse generators, the ASICore platform. These components can be applied to various neurostimulation applications, from spinal cord stimulation and deep brain stimulation to prosthetic control. (Business Wire)

Company Says Injectable Spinal Cord Stimulation System Received Marketing Clearance in Europe

Dec. 10, 2015 - Medical device distributor Stimwave Neuro LP announced CE Mark approval for Stimwave Technologies Incorporated's Freedom spinal cord stimulation system for pain relief of the back or legs. The system incorporates up to eight electrode contacts and an embedded chip, that are introduced into the body through a needle. (Business Wire)

Preliminary Results Presented in Phase I Clinical Trial of External Trigeminal Nerve Stimulation in Post Traumatic Stress Disorder

Dec. 10, 2015 - At the North American Neuromodulation Society meeting, NeuroSigma, Inc. presented preliminary findings from a Phase I clinical trial of external trigeminal nerve stimulation in combat veterans who have post traumatic stress disorder. The preliminary results indicate improvements in symptoms and desired changes in brain activity. (Pharmiweb.com)

Company Announces Its Deep Brain Stimulation Systems Have Expanded Conditional Approval for MRIs

Dec. 9, 2015 - Medtronic plc announced that systems within its Activa® portfolio of deep brain stimulation devices have received FDA approval for full-body magnetic resonance imaging under specific conditions of use. (Street Insider)

Company Announces FDA Approval of Its Neuromodulation Device for Chronic Back and Leg Pain

Dec. 9, 2015 - Stimwave Technologies announced it has received FDA clearance to market its  wireless neuromodulation device for relief of chronic back and leg pain. (Digital Journal)

Results Published in Clinical Trial of Vagus Nerve Stimulation During Stroke Rehabilitation; Company Plans Further Research and Announces Additional Funding

Dec. 9, 2015 - International Neuromodulation Society member Jesse Dawson, MD was quoted in an article about a small controlled study he and colleagues published in Stroke that suggests pairing vagus nerve stimulation with upper-limb rehabilitation is safe and feasible after stroke. Based on those results, MicroTransponder, Inc. is conducting a 20-patient followup study in the U.S. and the U.K. The privately held company announced that it has closed a $5.5 million round of funding to support its activities. (Medgadget)

Company Anticipates Distributing Its Transcranial Magnetic Stimulation Systems in Mexico in 2016

Dec. 8, 2015 - Brainsway Ltd. announced an exclusive distribution agreement with moksha8 in Mexico, where the distributor plans to make Brainsway's deep transcranial magnetic stimulation system available in 2016 as a treatment for major depressive disorder. (Globes)

Researchers Study Transcranial Magnetic Stimulation in Cocaine Addiction

Dec. 3, 2015 - A paper in European Neuropsychopharmacology reports on a small, controlled study of repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex as a potential treatment for cocaine addiction. Of the 32 patients in the study, 19 received active treatment for one month, while the other 13 in the control group received usual care. After one month, 69% of the patients in the treatment group had no positive drug tests, compared to 19% of patients in the control group. (Health Day)

Neurosurgeon is Recruiting Study Subjects to Test Spinal Stimulation in Paraplegia

Dec. 3, 2015 - International Neuromodulation Society member Peter Konrad, MD, PhD, is seeking patients with paraplegia for a proof-of-concept study of intraspinal microstimulation as a possible way to restore some complex body movement. (Vanderbilt)

Research Group Receives $2.4 Million to Study High Frequency Stimulation for Pain

Dec. 2, 2015 - The National Institute of Neurological Disorders and Stroke awarded a $2.4 million grant to scientists associated with the Cleveland Functional Electrical Stimulation (FES) Center for preclinical research into the pain-relieving mechanisms of high frequency spinal cord stimulation. (EurekAlert)

Company Receives Clearance to Test Implantable Device in Craniofacial Neuropathic Pain

Dec. 2, 2015 - StimRelieve LLC, announced it has received an FDA Investigational Device Exemption for a clinical trial of its injectable, wirelessly powered, stimulator to test the device for the treatment of refractory craniofacial neuropathic pain. Its Halo CFNS system is powered by an external transmitter placed on the ear. (Businesswire)

Stimulation Therapy for GERD Receives Approval in Brazil

Dec. 2, 2015 - EndoStim announced that ANVISA, the Brazilian health authority, approved its minimally-invasive therapy for gastroesophageal reflux disease (GERD) in Brazil. The EndoStim II LES Stimulation System is intended for patients who "may not be ideally treated with medication therapy," the company said. The stimulation targets the lower esophageal sphincter between the stomach and esophagus to improve or strengthen its function. (PR Newswire)

Projected Sacral Nerve Stimulation Costs to Be Presented at NANS

Dec. 2, 2015 - Axonics Modulation Technologies, Inc. announced that an abstract will be presented on Dec. 12 at the North American Neuromodulation Society (NANS) meeting that compares estimates of long-term treatment costs for overactive bladder using either rechargeable, or non-rechargeable, sacral nerve stimulators (SNS). The analysis is based on a model that uses a U.S. payer perspective. Results indicate a rechargeable system would have significantly lower costs per patient. Axonics is developing a rechargeable SNS system. (Businesswire)

Petition for Review Denied on U.S. Patent for High Frequency Spinal Cord Stimulation

Dec. 1, 2015 -  Despite two petitions challenging validity of some patent claims for high frequency spinal cord stimulation, the Patent Trial and Appeals Board (PTAB) at the U.S. Patent Office has decided to not conduct an inter partes review, the patent-holder, Nevro Corp., announced. http://www.prnewswire.com/news-releases/nevro-announces-the-us-patent-and-trademark-offices-denial-of-boston-scientific-petitions-for-inter-partes-review-of-us-patent-no-8359102-300185543.html The PTAB decided against holding a review after considering two petitions filed in May 2015 by Boston Scientific Corporation that challenged certain claims in Nevro's patent (U.S. Patent No. 8,359,102). (Fierce Medical Devices)

Company Announces FDA Approval for Spinal Cord Stimulation System

Nov. 30, 2015 - Greatbatch, Inc. announced FDA approval for its spinal cord stimulation system, Algovita®, which was developed by the company's subsidiary, QiG Group. The subsidiary is in the process of being spun out as Nuvectra Corporation, a process that is expected to be complete in the first quarter of 2016. (Nasdaq)

Regional Brain Center Opens in Southwest England

Nov. 27, 2015 - The University of Bristol is pooling expertise with the North Bistrol NHS Trust in the new Bristol Brain Centre that opened on November 25. The facility includes a deep brain stimulation service and health integration team for movement disorders that is designed to fully integrate all aspects of clinical care, translational research and education. (University of Bristol)

Review: Evidence for Neuromodulation in Emerging Indications

Nov. 25, 2015 - A review of clinical trials of neuromodulation in treating pain from coronary artery disease, peripheral vascular disease, headache, and peripheral field stimulation found "compelling evidence . . . that neuromodulation can be of benefit for patients with serious painful conditions that are not currently approved by the FDA." (Pain Practice)

Company Opens an International Headquarters in Germany

Nov. 25, 2015 - Autonomic Technologies, Inc. is opening a new international headquarters in Munich, Germany. The company is commercializing sphenopalatine ganglion stimulation for cluster headache, and its device has received CE Mark in Europe. (Market Wired)

Dopamine Detection Points to More-Complex Role in Learning

Nov. 23, 2015 - Rapid detection of dopamine in the brains of 17 patients with Parkinson's disease who were undergoing deep brain stimulation surgery suggests dopamine's role in learning and decision making is more complex than previously thought. The researchers used a carbon fiber electrode and fast-scan cyclic voltammetry to record dopamine fluctuations while the patients played an investment game. The data indicated that dopamine neurons appear to track not merely risk and reward, but also whether an outcome could have been better or worse. (EurkeAlert)

Deep Brain Stimulation Surgery Performed with Continuous MRI Guidance

Nov. 23, 2015 - MRI Interventions, Inc. announced the first MRI-guided electrode placement for deep brain stimulation surgery in Arizona, at the Banner - University Medical Center in Tucson. (CNN Money)

Researchers Investigate Impact of Vagus Nerve Stimulation on Sleep Breathing Disorders

Nov. 23, 2015 - A research study evaluated the effects of vagus nerve stimulator implantation on 23 patients with epilepsy. After implantation, 57.9% of the patients developed new-onset mild to moderate sleep breathing disorders. The researchers linked the problems to laryngeal motility patterns, and call for the need to routinely examine these issues before and after implantation, through collaboration between neurologists and otolaryngologists. (Neurology Advisor)

Group Eyes Commercialization of Neuromodulation to Control Bleeding

Nov. 22, 2015 - A nerve-stimulation device under development to control bleeding is expected to be subject to a new spin-out company in three months, as a step toward preparation for clinical trials. (Innovate Long Island)

Company Announces FDA Approval of Spinal Cord Stimulation System

Nov. 19, 2015 - St. Jude Medical announced FDA approval of its Proclaim Elite Spinal Cord Stimulation System, a non-rechargeable device that is upgradable to allow for new simulation waveforms and software updates. The patient controller and physician programmer use wireless and mobile technology for use during a trial phase and for tailoring stimulation parameters, respectively. (Fierce Medical Devices)

Company Says Its Device to Address Heart Failure Will Have Expedited FDA Review

Nov. 19, 2015 - Minneapolis-based CVRx announced that its neuromodulator to treat heart failure is the fifth device to enter the six-month-old FDA Expedited Access Pathway. The device is designed to reduce the workload of the heart through modulating the baroreflex system that helps control blood flow. The device activates the baroflex through the afferent (sensory) pathway, helping to restore autonomic balance between the sympathetic and parasympathetic systems. (Fierce Medical Devices)

Article Reports Factors Influencing Reluctance to Have Deep Brain Stimulation for Parkinson's Disease

Nov. 18, 2015 - Researchers in Seoul reported that of 186 patients who underwent deep brain stimulation (DBS) to the subthalamic nucleus for Parkinson's disease, 45% were reluctant. The main reasons were fear of complications (74%) and economic burden (50%). The main reasons they decided to undergo DBS were trusting the doctor’s decision (80%) and family encouragement (36%). (Parkinsonism & Related Disorders)

Company Receives Clearance to Market Non-Invasive Stimulation System in Europe

Nov. 16, 2015 - NeuroSigma Systems announced CE Mark approval for its external trigeminal nerve stimulation system to treat attention-deficit hyperactivity disorder in people aged 7 years or older. (Mass Device)

Clinical Trial Results Presented of Stimulation Therapy for Optic Neuropathy

Nov. 16, 2015 - EBS Technologies GmbH presented clinical trial results this month at an Annual Scientific Meeting of the Neuromodulation Society of the United Kingdom and Ireland, held jointly with and the German and Swiss neuromodulation societies in London. In the randomized controlled clinical trial that was presented at the meeting, 51 patients with optic neuropathy who received transorbital optic nerve stimulation, compared to 47 who received a placebo, were reported to show a significantly improved visual field. (Marketwired)

Column Addresses Spinal Cord Stimulation for Chronic Pain

Nov. 16, 2015 - A physician responded in his column to questions from a grandmother whose grandson was referred to spinal cord stimulation for post-herpetic neuralgia in the UK. He points out that the treatment is usually considered after more conservative measures have failed, and is recommended for neuropathic pain by the National Institute for Health and Care Excellence. (Daily Mail)

Researchers Develop Proof-of-Concept Brain-Monitoring Probe

Nov. 16, 2015 - An article details development of flexible polymer fibers that were demonstrated in mice for use as simultaneous electrical, optical, and chemical probes of brain activity. (SPIE)

Patients Recount Their Experiences with Transcranial Magnetic Stimulation

Nov. 15, 2015 - A long article on transcranial magnetic stimulation for depression describes the experience of two patients whose symptoms were lessened through using the therapy. (Lowell Sun)

News Feature Describes Potential for Vagus Nerve Stimulation Therapies

Nov. 13, 2015 - A news feature about vagus nerve stimulation covers its potential as a therapy for inflammatory disease and heart disease, as well as touching upon other existing or emerging indications, such as epilepsy and depression. (Science News)

Another Partner is Announced for Diaphragm-Pacing System

November 2015 - Oberlin, Ohio-based Valtronic is partnering with Synapse Biomedical to commercialize a third-generation, fully implantable diaphragm pacing technology. Valtronic and other partners plan to provide matching funds for the commercialization, which is being supported by a $3 million economic-development grant from Ohio Third Frontier. The device is also being commercialized in Asia with help from another partner, USCI Japan Ltd. (U.S. Tech)

Researchers Combine a Sensing Array with Light Stimulation for Optogenetic Studies

Oct. 12, 2015 - An article in Nature Methods describes development of a cortical sensing array with the capability to deliver light in a controlled pattern for optogentic studies. The array on transparent zinc oxide includes an optoelectronic actuator. The device was applied in transgenic mice to investigate light-perturbed cortical microcircuit dynamics and effects on their behavior. (Kurzweil)

Company Plans to Present Peripheral Nerve Stimulation Data Next Month

Nov. 12, 2015 - Israel-based BlueWind Medical plans to present details of its miniature leafless neurostimulator clinical trial in neuropathic pain patients during the North American Neuromodulation Society meeting in Las Vegas in December. The study was performed in four centers in Belgium and Poland, with up to six months' follow-up. (PR Businesswire)

Study Focuses on the Role of Brain Activity in Eating Behavior

Nov. 11, 2015 - International Neuromodulation Society member Brian Kopell, MD, commented in a news article about a small study of transcranial direct current stimulation as a potential intervention in obesity. He said such an intervention theoretically may block the impulse to eat high-sugar foods and allow the brain to return to its normal state in terms of sugar craving. (Endocrine Web)

Authors Voice Caution Regarding Brain Stimulation for Cognitive Issues

December 2015 - Co-authors based in Italy write that any use of deep brain stimulation in cognitive impairment, especially memory loss, should be reserved for investigational settings that have clear protocols and strict inclusion criteria. (Current Opinion in Neurology)

Optogenetics Researchers Receive a Technology Prize

Nov. 9, 2015 - Ed Boyden, PhD of MIT and Karl Deisseroth, MD, PhD of Stanford University were among five scientists to win Breakthough Prizes in life sciences at the third annual gala founded by Silicon Valley entrepreneurs. The prize is worth $3 million. The recognition they received acknowledges their work in developing optogenetics as a tool for understanding the function of brain circuits, and potentially developing therapies that address circuit disorders. (Business Insider)

Article Examines Concerns About "Home-Made" Electrical Stimulation Devices

Nov. 9, 2015 - An article covers concerns about interest in transcranial direct current stimulation among do-it-yourself enthusiasts. (Wall Street Journal)

Older Subgroup Showed Gains in Small Clinical Trial of Brain Stimulation in Alzheimer's Disease

Nov. 9, 2015 - In further details about Functional Neuromodulation's small Phase 2 clinical trial of deep brain stimulation to the fornix in patients with mild Alzheimer's disease, results showed some clinical benefit to a subgroup of patients aged 65 or older. This 30-patient subgroup had 15 patients in each of the sham and treatment arms, who were followed for 12 months. In the subgroup, treatment yielded a significant improvement, compared to the control group, in glucose metabolism. The subgroup patients who were treated also showed reduced cognitive decline but the study wasn't adequately powered to achieve statistical significance on the clinical measures used to track cognitive performance. (Fierce Medical Devices)

Optogenetics Recognized by Prize Competition

Nov. 10, 2015 - Breakthrough Prize winners announced in Northern California on Sunday included co-developers of optogenetics, who will receive $3 million each from organizers, who amassed fortunes through technology advances in Silicon Valley. The event is in its third year. (Reuters)

Company Reports on Past Fourth Months of Activities

Nov. 9, 2015 - Mainstay Medical International plc issues an Interim Management Statement from July 1, 2015 to the present. The statement said that the company submitted an application for CE Mark for its neurostimulation system for chronic low back pain, closed a debt financing for up to $15 million, and announced issuance of three U.S. patents during that period. (Business Wire)

Team Develops a Three-Dimensional Printed Brain Model

Nov. 8, 2015 - International Neuromodulation Society member Ivar Mendez, MD, PhD, head of surgery at the University of Saskatchewan, has worked with a team of engineers, MRI technicians, neuropsychology specialists and a radiologist to convert MRI data into a clear, three-dimensional printed structure that may be used in planning deep brain stimulation. (3dprint.com)

Company Plans to Enter Phase 3 Clinical Trial of Deep Brain Stimulation in Alzheimer's Disease

Nov. 6, 2015 - Functional Neuromodulation Ltd. announced it will start a Phase 3 trial of deep brain stimulation to the fornix in mid-2016. The company presented an analysis of its Phase 2 study, ADvance, at the 2015 Clinical Trials in Alzheimer's Disease meeting in Barcelona, Spain. The double-blind randomized controlled trial examined deep brain stimulation for mild Alzheimer's disease. (PR Newswire)

Patient Receives New Neurostimulator Device to Treat Heart Failure

Nov. 5, 2015 - A patient in Croatia is the first to begin using a catheter-based neurostimulator device to treat congestive heart failure, Enopace Biomedical, announced. The leadless, active miniature stimulator and is implanted in a 30-minute percutaneous procedure, and is designed to increase cardiac efficiency by reducing left ventricular workload. (PR Newswire)

Article Describes an Overactive Bladder Patient's Sacral Nerve Stimulation Therapy in India

Nov. 5, 2015 - An article says an elderly woman who had refractory overactive bladder for three years underwent the "new and specialized" treatment of sacral nerve stimulation. (Hans India)

Woman Says Her Depression Has Been Lessened Through Transcranial Magnetic Stimulation

Nov. 5, 2015 - A woman describes the benefits she received from transcranial magnetic stimulation treatment for depression. (KOAA)

Newscast Features Teen-Ager Who Receives Deep Brain Stimulation to Manage Dystonia

Nov. 4, 2015 - An article about a young man who received deep brain stimulation for dystonia calls it a rare and complicated surgery. The patient's mother added that she feels it has given him his life back. (KSTP)

Researchers Publish Proof-of-Concept Non-invasive Stimulation Approach to Weight Loss

Nov. 4, 2015 - A proof-of-concept study published in Obesity suggests that anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex may facilitate weight loss. (NIH)

Responsive Neurostimulation System Receives Recognition

Nov. 4, 2015 - NeuroPace, Inc. announced it received an award that recognizes its responsive neurostimulation system as the most promising new product of the year. The award was presented at the 2015 Phoenix Medical Device CEO Conference, which is comprised of medical device and diagnostic industry executives. (Business Wire)

Enrollment Opens in Clinical Trial of Transcranial Magnetic Stimulation in Adolescents with Treatment-Resistant Depression

Nov. 2, 2015 - Neuronetics, Inc. announced enrollment is beginning for a randomized controlled clinical trial to evaluate the acute and long-term effectiveness of transcranial magnetic stimulation in adolescent patients  aged 12-21 who have treatment-resistant depression. (PR Newswire)

Article Features Research Into Development of Prosthetic Devices to Address Memory Impairment

Nov. 3, 2015 - Two presentations at the Society for Neuroscience meeting in October described work funded by the Defense Advanced Research Projects Agency intended to develop devices to address memory impairment. The studies involved cortical readings made during assessment of epilepsy patients. One approach is based on mapping signals in the hippocampus associated with memory formation, which led to development of an algorithm that mimics that signaling with about 80% accuracy. Another approach is based on the observation that stimulation of the medial temporal lobe, which houses the hippocampus, improves periods of poor memory but impedes memory when it is functioning well. By stimulating only when memory was predicted to be poor, the researchers could boost recall up to 140%, (Nature)

Study Investigates Transcranial Direct Current Stimulation in Motor-Task Training

Nov. 2, 2015 - A Phase 2 double-blind trial of transcranial direct current stimulation, presented at the 44th Child Neurology Society Annual Meeting, involved 24 children aged 6 to 18 years old who had experienced a stroke at birth with resulting weaknesses at one side. Results showed that combining stimulation sessions with after-school occupational therapy led to improvements in subjects' ability to complete motor tasks, such as tying shoes. (Medscape)

Show Features Use of Deep Brain Stimulation to Treat Parkinson's Disease

Nov. 2, 2015 - International Neuromodulation Society member Corneliu Luca, MD, PhD was interviewed in a telecast about a Miami, FL-area woman who received a deep brain stimulation system to manage symptoms of Parkinson's disease. (WNDU)

Low Back Pain Therapy Developer Applies for CE Mark

Nov. 2, 2015 - Dublin-based Mainstay Medical has applied for CE Mark approval of its neurostimulation device to treat lower back pain. The company said that a study with 46 patients showed almost two-thirds had less lower-back pain three months after implantation, and more than half had their condition improve. In addition, the company said a little more than two-thirds of people treated reported a better quality of life and the benefits continued for six months. (Fierce Medical Devices)

Column Describes Promise of Noninvasive Approach to Potentially Enhance Brain Plasticity

Nov. 2, 2015 - Helius Medical Technologies, Inc. is developing a therapeutic approach to improve injury-associated brain-function impairment and related symptoms by combining physiotherapy with neurostimulation of the tongue. A columnist writes that the approach "will have a long path forward, but could be a real catalyst for retraining the human brain." (Forbes)

Results Reported in Pilot Clinical Trial of Noninvasive Stimulation for Multiple Sclerosis

Nov. 2, 2015 - A pilot study of a potential therapy for multiple sclerosis that combined physiotherapy with portable neuromodulation stimulation met all its objectives, Helius Medical Technologies, Inc. reported. The controlled clinical trial of 14 patients in Montreal suggested that a definitive clinical trial would require 128 subjects. Functional MRI results suggested that the investigational device may facilitate neural plasticity. (Business Wire)

To see select neuromodulation news by category, as well as news about the INS in particular, please visit the Newsroom. To see archived news briefs dating back to January 2011, visit the News Archive.

How Has Neuromodulation Been Developed and Used?

Conventional medicine has typically had four modes of treating diseases or disorders: counseling or “talk therapy”; physical therapy involving manipulation and strengthening of muscles and range of motion; pharmaceuticals that act on a chemical level; and altering or augmenting tissue through surgery, injections, or filtering methods like dialysis. The growing field of neuromodulation is a new class of therapies that involves directly treating the nervous system itself, often through small implanted devices that target a specific area, to rebalance the activity of neural circuits and manage symptoms.

Progress has been spurred by advances in our understanding of the nervous system, as well as new technologies and clinical experience, enabling treatments to modify nerve cell activity in brain, spinal cord and periphery to restore function, minimize pain, and treat disease symptoms. Developed over the last 45 years, neuromodulation has grown rapidly into a family of therapies that applies stimulation or agents directly to the nervous system, often using small implanted medical devices that are powered in a similar fashion to a cardiac pacemaker. By delivering electrical or chemical stimulation, neuromodulation has increasingly been used to treat motor disorders such as Parkinson’s disease, refractory chronic pain ranging from neuropathy to cancer related pain to severe headaches, spasticity, epilepsy, and incontinence. It is also under study for conditions ranging from gastroparesis to medically refractory depression. Providers of such therapies include neurosurgeons, pain physician specialists and rehabilitation physicians. They may often work with other specialists such as neurologists, psychiatrists, psychologists, gastrointestinal or colorectal specialists, urologists, primary care physicians, and physical therapists to achieve best outcomes.

Learn More . . .

Medical Professionals can learn about various considerations concerning neuromodulation and clinic contacts. Once your preliminary questions have been answered, please use the Contact Us facility to find out more and to discuss specific objectives. Others may simply wish to join the INS and one of its related chapter societies, please use Membership Application.

Clinical trials that involve a wide range of emerging neuromodulation approaches are listed on our Resources and Research pages. Neuromodulator trials address symptom control through nerve stimulation in such condition categories as:

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and you are searching for information about neuromodulation and how these types of treatment could benefit a specific condition such as treatment-resistant headache or other chronic pain syndromes, you may find the sections titled Therapies, About Neuromodulation or FAQs particularly helpful.

The International Neuromodulation Society (INS) is a non-profit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation - the alteration of nerve activity through the delivery of electrical stimulation or chemical agents to targeted sites of the body. Founded in 1989 and based in San Francisco, CA, the INS educates and promotes the field through meetings, its peer-reviewed journal Neuromodulation: Technology at the Neural Interface, explanatory content, and chapter websites.

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