2018 News Briefs - International Neuromodulation Society

Earlier News:

January - February 2018

Clinicians Publish Data From Short Study of Adaptive Deep Brain Stimulation in Parkinson's Disease

Feb. 21, 2018 - A study of 11 patients with symptoms of rigidity from advanced Parkinson's disease  showed motor symptoms improved almost 30% during an 8-hour course of adaptive deep brain stimulation (DBS). The two-day study explored the tolerability and safety of unilateral adaptive stimulation after patients were implanted with bilateral DBS systems that target the subthalamic nucleus. Adaptive DBS varies stimulation based on beta band brainwave activity, which is associated with movement. (MedPage Today)

New Neuromodulation Center in Toronto Will Focus on Clinical Research into Brain Stimulation

Feb. 21, 2018 - Donations totaling $10 million will establish the Harquail Centre for Neuromodulation at Sunnybrook in Toronto. An announcement says the center plans to focus on recruitment for clinical trials "of focused ultrasound and other highly sophisticated neuromodulation technologies". (Sunny brook Health Sciences Centre)

Study of Non-Invasive Brain Stimulation in Stroke Rehabilitation Suggests a Role for the Motor Cortex in Semantic Processing

Feb. 13, 2018 - A sham-controlled, double-blind study of transcranial direct current stimulation to the motor cortex in 16 patients who were undergoing language therapy for post-stroke aphasia showed a differential effect on processing of action words or object words. (Journal of Neurophysiology)

Television Producers Plan a Special Feature on Emerging Neuromodulation Technology

Feb. 22, 2018 - The television show Innovations plans to feature "the future of neuromodulation" in an upcoming show about the innovation of mid-field power, according to Neurspera Medical Inc., which is developing the technology to power medical devices. (PR Web)

Case Series Describes Non-Invasive Tinnitus Treatment

Jan. - Feb. 2018 - A published case series says transcranial direct current stimulation is "an effective intervention for tinnitus while inhibiting the dominant temporoparietal cortex and simultaneous stimulating the non-dominant dorsolateral prefrontal cortex." (Noise Health)

Device Maker Increases Access to Capital to Support Planned Expansion of Sales, Markets

Feb. 20, 2018 - Nuvectra Corporation announced an amended loan and security agreement of three tranches totaling $45 million, with an extended amortization period that goes to 2020. The company said it will use the agreement to expand U.S. sales of its spinal cord stimulation system, Algovita, and plan an entry into the sacral neuromodulation market. (Globe Newswire)

Company to Open New Manufacturing Facility for Neuromodulation Platform Technology

Feb. 20, 2018 - Med-Ally, which manufactures the VersaStim neuromodulation platform technology, plans to open a $2.38 million, 10,000 square foot facility in South Carolina next month that is expected to add 90 jobs to the company, which was founded seven years ago and reportedly has fewer than 50 employees. (Medical Design & Outsourcing)

Journal Articles Summarize a Clinical Trial of a Rechargeable Sacral Neuromodulation System

Feb. 20, 2018 - Axonics Modulation Technologies, Inc. announced publication of three clinical articles regarding a European clinical trial of its rechargeable sacral neuromodulation system in the Journal of Neurourology and Urodynamics. The articles include three-month follow-up results in 51 patients with overactive bladder. The data show that 31 of the 34 patients who responded to a trial period continued to show improvement at three months. (Business Wire)

Epidural Stimulation Helped Modulate Blood Pressure in Spinal Cord Injury Patient

Feb. 19, 2018 - A case report in JAMA Neurology http://bit.ly/2BGWg13 describes effects of acute epidural stimulation to improve cardiovascular dysfunction in a man with spinal cord injury. The authors say the stimulation "can excite sympathetic circuitry and instantaneously modulate cardiovascular function." (Science Daily)

Device Company Raises Funds to Complete Testing of Its Vagus Nerve Stimulation Device for the Treatment of Epilepsy

Feb. 19, 2018 - Neurostimulation company Synergia Medical SA announced it has raised €8.1 million in a Series A funding. The company intends to use the funding to complete testing of its vagus nerve stimulation device for medication-resistant epilepsy, NAOS, prior to CE mark submission. (Nasdaq)

Podcast Interview Features a Participant in a Study of a Neural Implant for Paralysis

Feb. 19, 2018 - A 30-minute interview during a meeting of the Society for Neuroscience presents the perspective of study volunteer Ian Burkhart, who has worked with researchers to regain some motor control of his hand and arm through the use of a cuff on his forearm connected to a neural array implanted above his motor cortex. Burkhart describes his motivations and activities he was able to achieve through the study. The initial study was extended and has continued nearly four years. (Neural Implant Podcast)

Pilot Study: Spinal Cord Stimulation Improved Gait in Patients With Advanced Parkinson's Disease

Feb. 14, 2018 - International Neuromodulation Society member Andrew Parent, MD, and colleagues have published a pilot study in which five patients with advanced Parkinson's disease received spinal cord stimulation (SCS) to improve gait, including freezing of gait. The patients were followed for six months. During that time, SCS settings were optimized using measurements of walking. The authors say they believe a longer and larger clinical study is warranted, due to an unmet need concerning these movement issues in this patient population. (Movement Disorders)

Proposed Algorithm Might Expedite Initial Programming of Deep Brain Stimulation Leads

Jan. 24, 2018 -  Researchers have published their work to develop a proposed algorithm to automate the first steps of programming cylindrical or directional leads for deep brain stimulation. They based the algorithm on a model derived from imaging, and demonstrated an example programming case for three lead designs to target the subthalamic nucleus for the treatment of Parkinson's disease. In their example case, the directional leads activated a greater volume of the stimulation target, in both central and off-target placements. They said a generic model might offer quick results for most patients, with more complex models for challenging scenarios. (Journal of Neural Engineering)

International Research Team Receives Multi-Year Grant for Neural Interface Technology

Feb. 15, 2018 - A $19 million grant over four years is allowing an international research team to develop so-called neurograins which are meant to be able to sense and stimulate wirelessly within the brain. The grant from the U.S. Defense Advanced Projects Research Agency's Neural Engineering System Design program will support work at  Brown University;  the University of California, San Diego; the University of California, Berkeley; Massachusetts General Hospital; Stanford University; Qualcomm; the Wyss Center for Bio and Neuroengineering; and the Belgium-based research group IMEC. (Brown University)

Proof-of-Principle Preclinical Study Shows Nanoparticles Allow Light-Mediated Brain Stimulation Without Implanted Optical Fibers

Feb. 14, 2018 - A research report in Science describes studies in mice showing that nanoparticles within the brain allow externally applied infrared light to up-convert to visible light, activating optogenetic cell channels in the neural tissue. The development is considered a potential future way to carry out optogenetic therapy without the need for implanted optical fibers. In the studies, the luminescent nanoparticles, which are injected and move within the brain, are energized by deeply penetrating near-infrared light that is shone outside the skull. The light-mediated cell activation in the experiments triggered memory recall and dopamine release. (Science Daily)

Article Highlights Potential Future U.S. Pilot Study of Deep Brain Stimulation for Addiction

Feb. 13, 2018 - A news feature surveys studies of deep brain stimulation for addiction, including interest at the new West Virginia University Rockefeller Neurosciences Institute. The institute director, International Neuromodulation Society member Ali Rezai, MD, described an intent to study brain implants for the most disabling and treatment-resistant cases of addiction, and less-invasive methods to help overcome addictive behavior -- saying the ultimate goal "is to not need implants." (STAT via Student Doctor Network)

Authors Review Randomized Trials of Cranial Electrical Stimulation

Feb. 13, 2018 - A review of 26 randomized trials of cranial electrical stimulation (CES) that reported pain, depression, anxiety or sleep outcomes in the Annals of Internal Medicine found "low-strength" evidence that CES can help people with depression and anxiety. The small, short-term, or otherwise limited studies did not provide sufficient evidence that the devices are effective in depression alone, insomnia, joint pain, or chronic headaches. (U.S. News & World Report)

Non-Invasive Brain Stimulation Studies Address Stuttering

Feb. 12, 2018 - A sham-controlled study of neurostimulation in 30 stutterers showed some promise lessening the severity. The study involved transcranial direct current stimulation (tDCS) to the left frontal cortex, which plays a role in speech planning and production. Another study is investigating high-definition tDCS to the supplementary motor area, an area involved in speech timing. (IEEE Spectrum)

In Case Report, Deep Brain Stimulation Reduced Tremor After Lesioning

Feb. 12, 2018 - A case report describes successfully using thalamic deep brain stimulation (DBS) of a previously lesioned target to regain tremor control. The patient had medically refractory essential tremor. Symptoms had recurred about six months after an initially successful unilateral thalamotomy accomplished through focused ultrasound ablation. The tremor was subsequently controlled through DBS that targeted the thalamic nucleus ventralis intermedius (Vim) on the same side as the previous lesioning. (Stereotactic and Functional Neurosurgery)

Company: Critical Limb Ischemia Improved in Preclinical Study

Feb. 12, 2018 - Endonovo Therapeutics, Inc. announced positive results in a study investigating the effects of its pulsed electromagnetic field device on critical limb ischemia in mice. (Globe Newswire)

Article Suggests Neuromodulation May Help Inflammatory Skin Disease

Feb. 9, 2018 - A commentary says that vagus nerve stimulation, due to its long-term safety profile and promising results in rheumatoid arthritis and irritable bowel disease, "could offer an optimal treatment approach for patients with recalcitrant inflammatory skin disease." (Dermatology and Therapy)

Review Discusses Effects of Burst Spinal Cord Stimulation to Treat Pain

Feb. 12, 2018 - International Neuromodulation Society members Krishna Chakravarthy, MD, PhD; Fang Xing, MD; and Thomas Kinfe, MD, PhD have published a review regarding spinal cord stimulation for pain that uses a burst mode. In it, they discuss possible modes of action and comment on clinical outcomes. (Neuromodulation: Technology at the Neural Interface)

Device Maker Enters Into $5 Million Cooperative Agreement to Develop Neurostimulation for Post-Stroke Spasticity

Feb. 7, 2018 - PathMaker Neurosystems Inc. entered into a four-year cooperative agreement, valued at nearly $5 million, with the National Institute of Neurological Disorders and Stroke to continue developing a non-invasive neurostimulation system to treat spasticity after stroke. The MyoRegulator device simultaneously stimulates spinal and peripheral locations. The company, based in Boston and Paris, said it will pursue multi-center clinical trials with coordination by Northwell Health and The Feinstein Institute for Medical Research. (Mass Device)

Study: Non-Invasive Brain Stimulation Appears to Improve Fatigue in Multiple Sclerosis

Feb. 7, 2018 - A news release announces a sham-controlled preliminary study in 33 patients showed that fatigue symptoms in multiple sclerosis patients were improved through six weeks of non-invasive brain stimulation. Active stimulation was carried out three times a week with a transcranial magnetic stimulation (TMS) device that is designed to reach deeper brain structures than standard TMS. The stimulation targeted the prefrontal cortex and primary motor cortex, according to the study that was published in Neuroimmunology & Neuroinflammation. (EurekAlert)

Researchers Evaluate Effects of Brain Stimulation on Processing of Negative Emotion

Feb. 6, 2018 - A study in Biological Psychiatry: Cognitive Neuroscience and Neuroimaging showed that modulating the right dorsolateral prefrontal cortex with either inhibitory or excitatory transcranial magnetic stimulation strengthened or weakened the processing of negative emotion, respectively, in healthy volunteers. The 41 volunteers were either shown images of fearful faces or neutral faces while receiving a single session of the stimulation. (News-Medical.Net)

Author: Funding Initiatives Aim to Advance Neuromodulation Effectiveness

Feb. 6, 2018 - An article describes federal funding in the U.S. of research to continue to further develop and refine neuromodulation technologies to make them more precise and tailored, which may lead to wider clinical adoption. (Medical Device and Diagnostic Industry)

Study: Closed-Loop Brain Stimulation Improved Memory Recall

Feb. 6, 2018 - International Neuromodulation Society member Ashwini Sharan, MD, and co-authors published results of a study showing that closed-loop stimulation to the lateral temporal cortex in 25 patients with epilepsy enhanced memory encoding and later recall. The closed-loop system monitored neural activity and applied stimulation when periods of poor recall were predicted. The patients were recruited at six centers where they were undergoing clinical evaluation of their epilepsy. In the study, funded by the U.S. Defense Advanced Research Projects Agency, the subjects' verbal recall improved by 15%, the researchers said. (Nature Communications)

Company Raises $17 Million for Commercialization of Non-Invasive Stimulator for Migraine

Feb. 6, 2018 - The medical device company eNeura Inc. received a $17 million investment round to expand marketing of its hand-held transcranial magnetic stimulation device for the treatment of migraine. The device is leased to patients on a trial basis for three months for $450, with a total of $750 to continue an additional three months. It can also be rented on an annual basis. (Baltimore Sun)

Clinical Trial Explores On-Demand Deep Brain Stimulation in Essential Tremor

Feb. 6, 2018 - A clinical trial at the University of Washington is evaluating demand-driven deep brain stimulation in essential tremor, according to a news feature about different types of brain stimulation research taking place at the university's Center for Sensorimotor Neural Engineering. (Seattle Times)

Neurosurgeons Elaborate on Their Publication Comparing Asleep vs. Awake Deep Brain Stimulation in Parkinson's Disease

Feb. 5, 2018 - Neurosurgeons at Oregon Health & Science University discuss a comparison https://www.ncbi.nlm.nih.gov/pubmed/28986415 of clinical outcomes of asleep vs. awake deep brain stimulation for Parkinson's disease. (Medscape)

Study Evaluates Changing Spinal Cord Stimulation Frequency with Patient Position

Feb. 5, 2018 - International Neuromodulation Society members Roy Hwang, MD, and Julie Pilitis, MD, PhD, and colleagues published a pilot study in 12 pain patients that evaluated alternating conventional spinal cord stimulation, when patients were upright, with high-frequency spinal cord stimulation when patients were lying down. In the 13-week crossover study, the patients were randomized to receive this so-called "shuffle" stimulation in four-week blocks. Mean pain scores were lower in the shuffle stimulation, and seven of 11 patients preferred it. (Neuromodulation: Technology at the Neural Interface)

Company Announces Progress in Its Portfolio of Visual Prostheses

Feb. 5, 2018 - International Neuromodulation Society member Nader Pouratian, MD, PhD, implanted a visual prosthetic that stimulates the visual cortex, the Orion Visual Cortical Prosthesis System, in January. The patient was the first to receive the implant in a feasibility clinical study by Second Sight Medical Products, Inc. The system is intended to restore some useful vision to patients who have lost sight due to a variety of reasons, such as glaucoma, diabetic retinopathy, or forms of cancer and trauma. The company added that its Argus II Retinal Prosthesis System, for patients with vision loss from retinitis pigmentosa, was implanted in 75 patients worldwide in 2017. (Second Sight)

U.S. Sales Begin of Central Sleep Apnea Device

Feb. 2, 2018 - Respicardia, Inc. announced the first commercial case of its transvenous phrenic nerve stimulator, the remedē System, being implanted in the U.S. to treat central sleep apnea. The company added that it has named industry veteran Peter Sommerness CEO, responsible for guiding its U.S. launch of the device. (Markets Insider)

First Patient Receives Sub-Retinal Implant in Visual Prostheses Study

Jan. 25, 2018 - Pixium Vision announced the first implantation and activation of its miniaturized wireless photovoltaic sub-retinal implant, PRIMA, in a patient with vision loss from dry age-related macular degeneration, as part of a stud to assess the implant's safety and performance in eliciting central visual perception. Up to five patients will be recruited for the study, which involves a re-education phase for the patient and follow up at six and 36 months. (Business Wire)

Device Maker Plans a Follow-On Stock Offering

Feb. 1, 2018 - Nuvectra Corporation announced a follow-on offering of 2,825,000 shares of common stock at a price of $8 a share. The offering is expected to close on or about Feb. 5, 2018. (Street Insider)

Study Indicates Sensory Response in Patients With Clinically Complete Spinal Cord Injury

Jan. 31, 2018 - Australian researchers found through fMRI imaging of 23 people with clinically complete spinal cord injury that in 48%, despite a lack of feeling, their brains were registering touch in response to having a paralyzed extremity brushed. The findings could be a basis for developing treatments such as brain computer interfaces or spinal cord stimulation. (Radio Australia)

Study Shows Memory Enhancement from Brain Stimulation of the Lateral Temporal Cortex

Jan. 31, 2018 - A research team reports in Brain on the effect of low-intensity electrical brain stimulation on memory in 22 patients who were undergoing epilepsy monitoring. The subjects were divided into four groups to receive the stimulation in four areas of the brain known to support recall. The four patients who received stimulation to the lateral temporal cortex showed enhanced performance on a memory recall test. (Reliawire)

Review Compares Brain Stimulation Targets in Parkinson's Disease

Jan. 31, 2018 - A review in JAMA Neurology compares deep brain stimulation to the globus pallidus interna and the subthalamic nucleus in patients with Parkinson's disease. The review indicates considerations when one target may be selected over another to take into account specific symptoms and anticipated effects. (MD Magazine)

Neurostimulation Headset Maker Raises $13 Million

Jan. 31, 2018 - Halo Neuroscience, which is marketing a neurostimulation headset to reinforce motor training and athletic performance, has raised $13 million in series B financing. After sports applications, the company said, it may branch out into augmenting rehabilitation or cognitive function. (MobiHealthNews)

Article Describes the Role of Neuromodulation With Respect to Chronic Pain and the Opioid Epidemic

Jan. 30, 2018 - International Neuromodulation Society members Jon Hagedorn, MD, and Timothy Deer, MD, published an article for an audience of medical trainees about neuromodulation therapy in the management of chronic pain in the context of the current opioid epidemic. (Student Doctor Network)

Study: Neurostimulation Improved Dysphagia Issues in Stroke Patients

Jan. 30, 2018 - A randomized study of 70 stoke patients showed that in 58% of the treated patients, 3 - 6 courses of daily electrical stimulation to the back of their throat enabled removal of their tracheotomy tube sooner, which had been placed due to swallowing difficulties causing pooling of saliva or aspiration pneumonia. A follow-on trial, PHEED, will study the device (Phagenyx by Phagenesis Ltd.) in stroke patients who have not been admitted to intensive care and are in a general rehabilitation ward. (Medscape)

External Vagus Nerve Stimulator Approved for Relief of Migraine Pain

Jan. 29, 2018 - The FDA has approved the hand-held vagus nerve stimulator, gammaCore, by electroCore LLC, for the treatment of migraine pain in adults. The device was approved for episodic chronic headache pain in April 2017. (Medscape)

Neurostimulation Feasibility Study Addresses Bladder Control in Patients with Spinal Cord Injury

Jan. 29, 2018 - A pilot neurostimulation feasibility study in five male patients who have spinal cord injury and neurogenic detrusor overactivity was conducted to inform design of a long-term clinical trial to evaluate sustained use of the approach. Electrical stimulation of the genital nerve, the terminal branch of the pudendal nerve, can acutely inhibit reflex bladder contractions, which are associated with these subjects' continence disorder, and increase bladder capacity. The feasibility study involved one month of at-home treatment with a portable, non-invasive device. (Uro Today)

Peripheral Nerve Stimulator Receives Canadian Approval

Jan. 29, 2018 - Bioness, Inc. has received approval from Health Canada to provide its peripheral neurostimulation system, StimRouter, for treatment of chronic peripheral nerve pain, excluding the cranial facial region. (Markets Insider)

Startup Founder Explores the Middle Eastern Market for a Gastric Electrical Stimulator

Jan. 28, 2018 - An interview details plans to commercialize the Intrapace closed-loop gastric electrical stimulator for obesity in the Middle East. (The National)

Article Recounts a Case of a Parkinson's Disease Patient Who Recently Received Deep Brain Stimulation in India

Jan. 28, 2018 - International Neuromodulation Society member Paresh Doshi, MBBS, MS (General Surgery), MCh (Neurosurgery), was quoted in an article about a patient who received deep brain stimulation for Parkinson's disease. Prof. Doshi was quoted as saying that it was the first time he has seen a patient immediately regain coherent speech after the surgery. (Hindustan Times)

Study Finds Benefit for Spinal Cord Stimulation in Critical Limb Ischemia

Jan. 26, 2018 - International Neuromodulation Society member Jung-Tung Liu, MD, PhD and colleagues have published a retrospective case-controlled 12-month study in 78 patients to identify the benefits and efficacy of spinal cord stimulation (SCS) as a therapeutic strategy for patients with perfusion problems from critical limb ischemia. After one year, the patients who had received SCS improved and had increased microcirculation in the lower limb, while the patients who did not receive it had worsened. The authors concluded SCS should be considered an effective treatment toward limb salvage in critical limb ischemia. (Neuromodulation: Technology at the Neural Interface)

Startup Plans to Develop Transcranial Direct Current Stimulation for Depression

Jan. 26, 2018 - A startup, Flow Neuroscience, backed by $1.1 million in seed funding, will combine a wearable brain stimulation device and behavioral training program with the intent to address depression. The device is being designed to deliver transcranial direct current stimulation. Based in Sweden, Flow Neuroscience announced plans to seek European market approval. (Fierce Biotech)

Study Will Evaluate Transcranial Magnetic Stimulation in Early Alzheimer's Disease

Jan. 26, 2018 - A research center in Montreal is one of three worldwide to conduct an ongoing study into transcranial magnetic stimulation in early to mid-stage Alzheimer's disease. The treatment is intended to aid thinking and memory. (CTV News Montreal)

Researchers Pursue an Implantable Drug-Delivery System for the Brain

Jan. 24, 2018 - Researchers at MIT are working on an implantable system to deliver medications to brain structures through hollow leads, detecting how electrical activity of targeted neurons change as the medication is delivered. The device includes an implantable reservoir, and has been demonstrated in small animal models of Parkinson's disease. (Washington Post)

Company Plans Phase 3 Clinical Trial of External Neurostimulation Device to Abort Migraine Attacks

Jan. 25, 2018 - Cefaly Technology announced it plans a Phase 3 trial of its external trigeminal nerve stimulator as a first-line abortive treatment for migraine. The company said data to date show the treatment outperforming abortive migraine medication. (Mass Device)

Health Insurer Starts Trial of Transcranial Magnetic Stimulation in Medication-Resistant Depression

Jan. 25, 2018 - In Australia, the insurer Medibank is funding a national, 12-month-long trial of up to 500 patients to assess the efficacy and cost-effectiveness of transcranial magnetic stimulation (TMS) in medication-resistant depression. The trial follows an Adelaide University study that concluded it can be an effective treatment, in addition to a finding in the U.S. that TMS was effective in 58% of patients with medically refractory depression. The treatment has been available in Australia for about 10 years at a cost of about AUS$3,600. There were two prior attempts to add TMS to the reimbursement schedule of the country's public healthcare system, Medicare. The insurer's chief medical officer is quoted as calling it a "simple and easy" treatment "for a significant disease area." Currently 70 patients have been enrolled. (The Advertiser)

Neurostimulation Registry Shows Symptom Improvement in Cluster Headache Patients

Jan. 25, 2018 - Autonomic Technologies, Inc. announced results of a prospective registry study published in The Journal of Headache and Pain showing that in 85 cluster headache patients who were followed for one year, sphenopalatine ganglion (SPG) stimulation reduced frequency and/or pain of cluster headache attacks in 68% of patients. The company's SPG neurostimulator is CE marked in Europe and under study in the U.S. for acute relief of chronic cluster headache. (Cision)

Researchers Demonstrate Quick, Intuitive Calibration for Brain Computer Interface

Jan.24, 2018 - Three people with tetraplegia were able to use the BrainGate brain machine interface (BCI) to control a cursor with their thoughts in three minutes or less after one simple calibration step, according to newly published research in the Journal of Neural Engineering. International Neuromodulation Society member Jaimie Henderson, MD, commented in news coverage of the work that a new participant, who was able to move a cursor around a screen within 37 seconds, performed as well as others who had been using the system for months or years. The calibration used statistical learning algorithms to decode the patients' intent as they imagined physically moving the cursor. The article said this development holds promise for future users and caregivers to more easily use a BCI, removing the need for technician oversight of calibration. (Science Daily)

U.S. Department of Defense Grant to Support Research Into Brain Stimulation for Functional Recovery

Jan. 24, 2018 - A researcher who has tracked brain activity during recovery of a patient who received a hand transplant after an accident has received a $1.7 million grant from the U.S. Department of Defense to study whether non-invasive brain stimulation can enhance nerve recovery during rehabilitation. (Health Imaging)

Silicon Valley Company That is Developing Mid-Field Power for Neuromodulation Raises $26 Million

Jan. 24, 2018 - Neurspera Medical Inc., which is developing implantable mid-field powering technology for neuromodulation applications, closed a $26 million round of Series B financing. The privately held company in based in San Jose, Calif., USA. (Vision)

Medical Technology Company Acquires Neurostimulation Company and Its Hypoglossal Nerve Stimulation System

Jan. 23, 2018 - LivaNova closed a $225 million buyout of ImThera Medical. ImThera's hypoglossal nerve stimulator for obstructive sleep apnea received FDA clearance for a clinical study that is expected to be completed by March. LivaNova, which had already invested in ImThera, paid $78 million to acquire the rest of the company and pledged an additional $147 million based on regulatory and sales milestones. (Mass Device)

Non-Invasive Brain Stimulation System Company Receives R&D Loan

Jan. 23, 2018 - Nexstim Plc announced it has received a research-and-development loan of approximately EUR 1 million codevelop a next-generation user interface for its navigated transcranial magnetic stimulation system to treat major depressive disorder and chronic neuropathic pain. (Nasdaq)

March Deadline Announced for Neuromodulation Research Prize for Early Career Investigators

January 2018 - The deadline for the 2018 Science & PINS Prize for Neuromodulation is March 15, 2018. Entrants must be a junior investigator, with an advanced degree received in the last 10 years, who are 45 years old or younger and who submit research they performed or directed in the last three years. The application requires an essay that describes the work's implication for the field of neuromodulation. (Science)

University Team Works to Add Sensory Feedback to Prosthetic Limbs

Jan. 14, 2018 - Researchers at the University of Pittsburgh are working on adding sensory feedback to existing prosthetic limbs through functional electrical stimulation. A processor module calibrates and scales information from six sensors, and translates the information into a stimulation pattern that can be relayed to existing stimulator systems to provide somatosensory feedback. The project, uHaptic, aims to standardize attachment of peripherals and streamline communication between sensors and feedback delivery systems. (Medstro)

Collaboration Announced on Closed-Loop Brain Stimulation System

January 2018 - The Wyss Center and CorTec GmbH announced a collaboration to develop a brain monitoring and stimulation device for diagnostic and therapeutic applications. An implanted component consists of neural electrodes along with an electronic unit that communicates wirelessly with an external power/telemetry system, which in turn communicates with a computer. The computer records data and autonomously controls the application. (CorTec)

Study Evaluates 12-Month Data on Deep Brain Stimulation in Patients with Tourette Syndrome

Jan. 16, 2018 - A study of 171 patients with Tourette syndrome in a prospective international registry found that one year after undergoing deep brain stimulation (DBS), their average tic severity improved by 45%. The overall registry includes 185 patients from 10 countries who underwent DBS from 2012 through 2016. A paper in JAMA Neurology concludes the intervention was associated with symptomatic improvement in patients who have medically refractory Tourette syndrome, but also with stimulation-related adverse events that were likely reversible. (MD Magazine)

Interview Focuses on Recent Evolution of Neurostimulation in Trigeminal Neuralgia

Jan. 16, 2017 - In an interview about the prospects for peripheral nerve stimulation in trigeminal neuralgia, a physician says new data that are beginning to show optimizing settings of spinal cord stimulators may lead to better outcomes and quality of life for many pain patients may be applicable to peripheral nerve stimulation as well. (Clinical Pain Advisor)

Non-invasive Brain Machine Interface Study Suggests Potential for Post-Stroke Rehabilitation of Hand Paralysis

Jan. 15, 2018 - Research in the Journal of Neuroscience describes a demonstration in healthy subjects of a non-invasive brain machine interface that could potentially aid in physical rehabilitation of hand paralysis in stroke patients. The interface combines a robotic device controlling hand movement with transcranial magnetic stimulation to the motor cortex. The research demonstrated increased output of neural pathways connecting the brain and spinal cord. (Medical Xpress)

Two-Year Data Presented Concerning a Spinal Cord Stimulation System that Offers a "Burst" Mode

Jan. 15, 2018 - Two-year outcome data were presented at the annual meeting of the North American Neuromodulation Society concerning Abbot Laboratories' Sunburst trial of its Proclaim spinal cord stimulation system. The data reflected the extent to which the 42 pain patients who were followed preferred either tonic stimulation, or a "burst" mode option. (Star Tribune)

Clinical Data Presented Regarding Two Companies' Neuromodulation Devices

Jan. 12, 2018 - An article covers announcements by Medtronic plc and Boston Scientific Corporation about studies the companies presented at the annual meeting of the North American Neuromodulation Society. Medtronic announced results of its Sisters study that compared treatment for spasticity after a stroke using either oral baclofen or baclofen delivered intrathecally with the company's implantable intrathecal drug delivery system, SynchroMed II. Boston Scientific presented data from its randomized controlled clinical trial, Whisper. The data showed a difference in how many patients could effectively control their pain with the company's Precision spinal cord stimulation device by either being limited to a single stimulation mode or having a choice of two different stimulation modes.

Company Announces Presentation of Data from Studies of High-Frequency Spinal Cord Stimulation

Jan. 12, 2018 - Nevro Corp. announced presentations at the annual meeting of the North American Neuromodulation Society. These include data regarding a study of the company's high-frequency spinal cord stimulation in intractable neck and/or upper limb pain; a study of the device in peripheral polyneuropathy that has led to a new trial in painful diabetic neuropathy; and a study in non-surgical refractory back pain. (Medical Device News Magazine)

FDA Approval Announced for Spinal Cord Stimulator that Varies Frequency, Pulse Width, and Amplitude

Jan. 11, 2018 - Boston Scientific Corporation announced pre-market approval from the FDA for its spinal cord stimulation device that permits varying frequency, pulse width and amplitude, the Spectra WaveWriter. (Mass Device)

Peripheral Nerve Stimulator Data Presented in Poster Sessions

Jan. 11, 2018 - Bioness, Inc. announced that data from four studies will be presented during poster sessions at the annual meeting of the North American Neuromodulation Society about its peripheral nerve stimulator, StimRouter. The studies concern use of the device for chronic pain originating from the peripheral nerve region of the shoulder, tibia and other areas of the body. (Markets Insider)

FDA Approves Changes to Intrathecal Drug Delivery Device

Jan. 10, 2018 - The FDA has approved design changes and a new programming interface for Medtronic plc's SynchroMed II intrathecal drug delivery device. (Start Tribune)

Company Plans Post-market Study of Its Neurostimulation Therapy Workflow

Jan. 10, 2018 - Medtronic plc has enrolled its first patient in a prospective, multi-center post-market study of its Evolve workflow that it says standardizes guidance that balances spinal cord stimulation settings between high-dose and low-dose. The study will follow up to 175 chronic pain patients treated with this SCS system at up to 25 U.S. sites for one year. (MD+DI)

Neurostimulation Device Company Plans Product Launch

Jan. 10, 2018 - Stimwave LLC announced it has agreed to more than $50 million in additional financing to launch its wireless neurostimulator for chronic pain. The company plans a consumer event March 1 in Columbus, Ohio, at the the First Annual Medical Conference for Recovery, Regeneration, and the Athlete, as part of the launch. (Business Wire)

Case Report: Occipital Nerve Stimulation for Migraine Associated with Reduction in Epileptic Seizures

January 2018 - A case report describes how an epileptic patient who receive occipital nerve stimulation for intractable migraine experienced unexpected seizure reduction, with seizure-free periods between two episodes of lead migration requiring revision. (Regional Anesthesia and Pain Medicine)

Temporary Electrical Stimulator to Treat Patients on Mechanical Ventilation Receives CE Mark

Jan. 8, 2018 - Synapse Biomedical Inc. announced CE mark approval of its temporary diaphragm stimulator for patients in the intensive care unit. The device is a percutaneous intramuscular electrical stimulator. Its use in patients who are on mechanical ventilation is meant to minimize atrophy of the muscle and treat ventilator-induced diaphragm dysfunction. (Business Wire)

Responsive Neurostimulator Data Reveal Seizure-Prone Monthly Cycles in Patients with Epilepsy

Jan. 8, 2018 - Data gathered from responsive neurostimulator implants in 37 epilepsy patients, for a median of 2.25 years, show that the patients have both daily cycles in seizure risk, but also longer cycles of rising and falling brain irritability that lasts weeks or months. The researchers published in Nature Communications an analysis that indicates seizure risk is almost seven times greater when the most seizure-prone periods of those cycles overlap. (Science Daily)

Spinal Cord Stimulation System Receives FDA Approval

Jan. 8, 2018 - The FDA has approved Nevro Corporation's updated spinal cord stimulation system with a reduced-size implantable pulse generator, Senza II. (MD Magazine)

Rechargeable Sacral Neuromodulation System Receives Australian Approval

Jan. 8, 2018 - Axonics Modulation Technologies, Inc. announced it has received marketing approval in Australia for its rechargeable sacral neuromodulation system to treat overactive bladder, fecal incontinence and urinary retention. The device has been approved in Europe and Canada and is undergoing a pivotal U.S. study designed to support an application for pre-market approval there. (Business Wire)

Study Evaluates Brain Effects of Non-Invasive Neurostimulation Device

Jan. 8, 2018 - Helius Medical Technologies, Inc. announced that a study in 20 healthy volunteers showed its non-invasive, investigational device that delivers neurostimulation through the tongue exerted statistically significant changes in brainwave activity as observed in EEG. For instance, during a 20-minute rest period following a 20-minute session of high frequency stimulation, alpha and theta brainwaves increased. The study evaluated high frequency and low frequency stimulation, in random order, in single sessions one week apart. (Nasdaq)

Enrollment Complete in Stroke Rehabilitation Study

Jan. 6, 2018 - Nexstim Plc has completed enrollment in a supplementary Phase III clinical trial that evaluates its navigated transcranial magnetic stimulation system in post-stroke rehabilitation of upper extremity function. (Globe Newswire)

Multi-Year, Multi-Site Post-Market Study Begins of Implanted Vagus Nerve Stimulation as an Adjunctive Treatment in Treatment-Resistant Depression

Jan. 4, 2018 - Livanova PLC announced it has enrolled its first patient in a post-market study of implanted vagus nerve stimulation as an adjunctive treatment for patients with difficult-to-treat depression. The study, RESTORE-LIFE, will enroll at least 500 patients at up to 80 sites outside the U.S., and follow-up will run from three to five years. (Markets Insider)

Transcranial Direct Current Stimulation Studied in Bipolar Depression

Jan. 4, 2017 - An investigator in Brazil published in JAMA Psychiatry results of a controlled clinical trial of transcranial direct current stimulation in bipolar patients. The study of 52 patients showed that a series of active stimulation sessions during a major depressive episode resulted in 67.6% becoming responders, and 37.4% experiencing remission. In contrast, sham treatment led to a 30.4% responder rate and 19.1% entering remission. (Psych Congress Network)

Magazine Highlights Brain Computer Interface Research

Jan. 4, 2018 - A comprehensive technology feature summarizes recent research into brain computer interfaces. The article says 13 people have been implanted since 2004 with the BrainGate system, designed to provide a degree of intentional movement to people who have been paralyzed, allowing them to complete simple tasks, such as moving a cursor or controlling a limb. (The Economist)

Prototype Portable Prosthetic Hand Provides a Sense of Touch

Jan. 3, 2018 - Scientists in Italy unveiled a prototype prosthetic hand that provides a sense of touch using electronics that are compact enough to fit in a backpack. A patient who used the device for six months was able to distinguish between hard and soft objects while blindfolded, and to use the prosthetic for tasks in which having the tactical feedback is helpful, such as dressing, she said. (BBC News)

Six-Month Results Published in Study of an Implanted Tibial Nerve Stimulator to Manage Symptoms of Overactive Bladder

Jan. 4, 2018 - BlueWind Medical announced publication of 6-month study results of its implantable tibial nerve stimulator in patients with refractory overactive bladder. The authors reported that 71% of the 34 patients who competed the study experienced at least a 50% reduction in symptoms. (Pharmiweb.com)

Company Announces the First Enrollees have Begun Receiving Implants in a Clinical Trial of a Rechargeable Sacral Neuromodulation System

Jan. 3, 2018 - Axonics Modulation Technologies, Inc. announced the first 11 patients were implanted in the U.S. and Europe in its clinical study of its rechargeable sacral neuromodulation system for the treatment of urinary and bowel dysfunction. The study is designed to prepare an application for premarket approval in the U.S. (Digital Journal)

Study: Occipital Nerve Stimulation is Potentially Safe and Effective in Refractory Cervicogenic Headache

Jan. 3, 2018 - An article that appeared online Nov. 27, 2017 in Neuromodulation: Technology at the Neural Interface reported a retrospective chart review of 16 patients who were treated with occipital nerve stimulation (ONS) for their daily, moderate-to-severe, refractory cervicogenic headaches. The patients were followed for three years; at one year, 69% were considered responders, and at three years, 37.5% were. (Neurology Advisor)

Translational Study Shows Potential Promise to Address Tinnitus Through Bimodal Stimulation

Jan. 3, 2018 - A double-blinded, sham-controlled, crossover clinical study of bimodal stimulation in adults with tinnitus provided evidence to support a larger clinical trial, according to an interview with the researcher. The approach combines sound and skin stimulation in an intent to target nerve activity in the brain. Animal studies established that phantom sounds are signaled to the brain through fusiform cells. (U.S. News and World Report)

Article: U.K. Experts Call for Neuromodulation to Be More Widely Available through the National Health Service

Jan. 1, 2018 - International Neuromodulation Society members Serge Nikolic, MD and Simon Thomson, MBBS, FRCA, FIPP were quoted in an article about a chronic pain patient who received spinal cord stimulation after 40 years of trying other methods. The article quoted Dr. Nikolic as saying he believes the therapy is cost-effective. Dr. Thomson described wait times under the current National Health Service referral scheme, saying more patients would benefit than are receiving the devices. (Daily Mail)

Last Updated on Thursday, February 22, 2018 02:59 PM