2018 News Briefs - International Neuromodulation Society

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January - December 2018

Clinical Trial Involves Targeted Drug Delivery in Pain Patients

Nov. 15, 2018 - The Rockefeller Neuroscience Institute at West Virginia University has enrolled the first patient in a phase III clinical trial to test the effectiveness of injecting a clonidine micropellet into the lower back to treat sciatica pain for up to one year. (WVU Today)

Context Provided Concerning News Articles About Spinal Cord Stimulation

Dec. 19, 2018 - The International Neuromodulation Society offers context for a recent group of articles published by the Associated Press about spinal cord stimulation. (International Neuromodulation Society)

Company Announces a European Full-Body Conditional MRI Approval for Its Device

Dec. 18, 2018 - Nuvectra Corporation announced it has received European conditional approval for its Algovita spinal cord stimulator for full-body MRI scans. (Medgadget)

Company Announces FDA Approval of Device Programmer

Dec. 17, 2018 - Medtronic announced it has received FDA approval for a mobile, handheld, app-based programmer for use with its sacral neuromodulation system. (Pilot Online)

Child With Respiratory Paralysis from Accident Receives Phrenic Nerve Stimulation Implant

Dec. 12, 2018 - A 7-year-old boy from Kenya who received a cervical spine injury when hit by a motor vehicle, and required mechanical ventilation, received a phrenic nerve stimulator and was weaned off the ventilator in India, allowing him to become more mobile one year after his injury. He will receive follow-up care in his own country. (Specialty Medical Dialogues)

Company Announces an FDA Head-Only MRI-Conditional Approval

Dec. 12, 2018 - Nuvectra announced it received FDA head-only conditional approval for its spinal cord stimulation system. (Neuro News)

Company Seeks CE Mark for Device to Treat Balance Deficit

Dec. 12, 2018 - A noninvasive device for the treatment of chronic balance deficit due to mild to moderate traumatic brain injury is subject to a CE mark application. The application was made by a subsidiary of the device company Helius Medical Technologies, Inc. (Globe Newswire)

Joint Venture Centers on Deep Brain Stimulation Surgery Navigation

Dec. 11, 2018 - An Israeli startup that designs targeting tools for deep brain stimulation has received a $7 million investment from the Guangzhou Sino-Israel Biotech Investment Fund, which is setting up a joint venture of the company and fund in China. (Globes)

Paper Explores Impact of Neurostimulation Treatment on Early Disability Pension

Nov. 26, 2018 - Co-authors in Finland published a case-controlled study of the effect of spinal cord stimulation on early disability pension in 198 patients who have failed back surgery syndrome. (Neurosurgery)

Research Into Stroke Lesions Suggests Potential Stimulation Targets for Arousal From Coma

Dec. 6, 2018 - A researcher suggests that stimulating structures deeper than the thalamus might be better for arousing someone from a coma, after he led a study into the location of stroke lesions and consciousness in the initial hours after a stroke. (Daily Iowan)

Canada Clinic Adds Neuroplasticity Stimulator

Dec. 6, 2018 - A neurorehabilitation clinic in Montreal is the first to use a noninvasive stimulator, recently approved by Health Canada, to stimulate neuroplasticity during intensive physiotherapy sessions. The stimulator sits on the tongue, which sends information to the brain through cranial nerves. (CTV News Montreal)

Israeli Company Develops a Neurostimulator to Potentially Treat Migraine Pain

Dec. 5, 2018 - An article describes a noninvasive stimulator being developed by an Israeli company for the treatment of migraine. The head-worn device has six electrodes to stimulate different nerve branches. The article mentions a clinical trial, and regulatory approval plans, as well as future interest in a potential related device to address depression. (Israel21c)

Device Maker Registers Offering of Common Stock

Dec. 4, 2018 - Inspire Medical Systems, which makes a neurostimulation device for treating obstructive sleep apnea, is offering 1.5 million shares of common stock and hopes to make $66.8 million on the sale. In addition, stockholders are selling an additional 1 million shares of stock. The company had an initial public offering in April. (Mass Device)

Statement on FDA Safety Communication

Nov. 22, 2018 - The INS has issued a statement regarding a Nov. 14, 2018 FDA safety communication about the off-label use of medications in implanted pumps for the treatment of pain. (Full INS statement) (International Neuromodulation Society)

Device Company Files for FDA Approval

Dec. 4, 2018 - Axonics has filed a literature-based FDA pre-market approval application for its rechargeable sacral nerve stimulator treatment for urinary and bowel dysfunction. In parallel, the company is running a pivotal trial of 129 patients with urinary dysfunction. (Mass Device)

Researchers Publish Proof-of-Concept in Investigation of Motor Cortex Stimulation from an Electrode Array in a Blood Vessel

Dec. 4, 2018 - Collaborators in Australia published a preclinical proof-of-concept study in Nature Biomedical Engineering in which an electrode array mounted on an endovascular stent was used to stimulate cortical tissue, in sheep, from within a blood vessel. The focal motor-cortex stimulation is being investigated as a potential future treatment for conditions such as epilepsy or Parkinson's disease. (The Recorder)

Neurostimulation Aids Violinist Who Has Complex Regional Pain Syndrome in the Shoulder

Dec. 3, 2018 - A woman who developed complex regional pain syndrome (CRPS) following surgery for an injury has been able to play and teach violin again after receiving a spinal cord stimulator (SCS) implant. She initially received an SCS implant in her lower back for leg pain in 2014 that had confined her to a wheelchair. More recently, she received a second SCS implant in her cervical spine after CRPS symptoms appeared in her shoulder following shoulder surgery. (UAMS News)

Long-term Results of Responsive Neurostimulation in Epilepsy Announced

Dec. 2, 2018 - NeuroPace announced results of a nine-year study, at 33 centers, of its responsive neurostimulation system in 256 patients with focal seizures that have not responded to medication. (Business Wire)

Article Surveying Migraine Treatment Includes Neurostimulation

Dec. 1, 2018 - An article about pharmaceutical migraine treatments ends by mentioning noninvasive or minimally invasive neurostimulation approaches that have become available or are under study. (Washington Post)

Brain Stimulation Target Explored for Improving Depressed Mood

Nov. 29, 2018 - Researchers published research in which they explored the lateral orbitofrontal cortex as a stimulation target to improve mood. (Science Daily)

Interest Increases in Understanding Brain Oscillations' Role and Therapeutic Potential

Nov. 29, 2018 - An article discusses emerging interest in a possible role for gamma waves in mental processing, and mentions the development of potential neurostimulation therapies based on observations of neural oscillations. (Scientific American)

Neuromodulation is Among Innovation Challenge Winners for Potentially Helping to Address Opioid Crisis

Nov. 30, 2018 - A deep transcranial magnetic stimulation device was among eight proposals, out of more than 250 submissions, selected in an innovation challenge by the FDA Center for Devices and Radiological Health that sought approaches to combat opioid use disorder, for instance, through managing pain. (FDA Voices)

U.K. Health System Adds Sacral Neuromodulator to Supply Chain

Nov. 29, 2018 - Axonics announced its sacral nerve stimulator has been added to a centralized supply catalogue for U.K. National Health Service hospitals. (Business Wire)

Researchers Pursue an Ultrasonic Implant to Stimulate and Record Brain Activity

Nov. 29, 2018 - With a grant of nearly $500,000 from the National Institutes of Health BRAIN Initiative, researchers have begun pursuing development of a wireless brain-monitoring implant. The envisioned device would rest on the surface of the brain and ultrasonically stimulate brain regions with the help of an external, wearable, unit. The ultimate goal is to record neural activity with high resolution, and possibly apply the technology to future deep-brain stimulation therapy for movement disorder, epilepsy, or other conditions. (Penn State)

Noninvasive Device Receives Clearance for Preventive Treatment in Cluster Headache

Nov. 28, 2018 - ElectroCore announced an expanded FDA approval for its handheld vagus nerve simulator, which is now cleared for adjunctive use in preventive treatment of cluster headache. (Mass Device)

U.S. Centers for Medicare & Medicaid Services Proposes a Clinical Trial of Vagus Nerve Stimulation for Treatment-Resistant Depression

Nov. 26, 2018 -  The U.S. Centers for Medicare & Medicaid Services has proposed obtaining more data as it looks to adjust its 2007 determination of non-coverage for vagus nerve simulation for treatment-resistant depression. The agency proposes a double-blinded, randomized, placebo-controlled trial with a one-year follow-up and the possibility of extension into a prospective longitudinal study. (Mass Device)

Clinicians Explore Cerebellar Transcranial Magnetic Stimulation in Patients With Post-Stroke Hemiparesis

Nov. 26, 2018 - An article in JAMA Neurology reports stimulating the cerebellum in post-stroke hemiparesis, using intermittent theta-burst magnetic stimulation in conjunction with physical therapy to improve gait and balance in patients who had ischemic stroke. (MedPage Today)

Paper Presents Six-Month Follow-up of Neurostimulation in Pain Patient with Brachial Plexus Injury

Nov. 27, 2018 - A team of co-authors in Italy report neurophysiological observations after switching from tonic to high-frequency spinal cord stimulation for six months in a pain patient who had brachial plexus root avulsion. 

Retrospective Analysis Evaluates 12-Month Pain Treatment Clinical Outcomes and Healthcare Utilization

Nov. 20, 2018 - In a retrospective analysis at a community-based pain facility, investigators evaluated clinical outcomes and healthcare utilization at 12 months post-spinal-cord-stimulator implant, compared with baseline and a matched sample of patients who received conventional medical management for low back and lower extremity pain. The analysis included tracking changing levels of opioid use. (Journal of Pain Research)

Initial Public Offering Raises an Additional $18 Million Through Exercise of an Over-allotment Option

Nov. 19, 2018 - Investors exercised an over-allotment option that added $18 million to the proceeds of the initial public offering for Axonics Modulation Technologies. Exercise of that option took gross proceeds to $138 million. (Mass Device)

Dorsal Root Ganglion Stimulation Trial System Receives FDA Clearance and CE Mark Approval

Nov. 15, 2018 - Abbott has won FDA clearance and CE Mark approval for its DRG Invisible Trial System, which chronic pain patients can control wirelessly during the trial phase, using a handheld device. (Mass Device)

Feature Profiles a Brain-Machine Interface Researcher and a Paralyzed Patient

Nov. 26, 2018 - An article traces a years-long research project that led to two paralyzed patients controlling a robotic arm with their thoughts, using a brain-machine interface. (New Yorker)

Chronic Low Back Pain Patient Study Data Released

Nov. 19, 2018 - Data from up to one year has been released in an active sham-controlled trial of an implantable neurostimulator for chronic low back pain. (NeuroNews)

Article Raises Awareness of Neurosurgery Advances in India

Nov. 17, 2018 - An article that gives examples of technological advances in neurosurgery in India mentions successful use earlier this year of deep brain stimulation to rouse a patient who had fallen into a coma due to hypoxic brain injury. (The Week)

Collaborators Present Their Approach to a Biofuel Cell for Microscale Biomedical Devices

Nov. 16, 2018 - Collaborators in the U.S. and Korea have demonstrated a potential future way of powering implanted medical devices. They created a biofuel cell that chemically converts glucose to electrical energy. The unit uses electrodes made of gold nanoparticles on cotton fiber, a substrate picked to enhance porosity, conductivity, and potential biocompatibility. (Endgadget)

Researchers Study Brain-Activity Response to Occipital Nerve Field Stimulation in Fibromyalgia

Nov. 12, 2018 - A research team published measurements from a positron emission tomography study in a few fibromyalgia patients who are being treated with occipital nerve field stimulation. They explored activation of pain pathways involved in descending inhibition, attention, and pain processing. (BMC Neurology)

Complex Regional Pain Syndrome Patient Receives Peripheral Nerve Stimulation Device

Nov. 15, 2018 - A recently FDA-cleared single-lead peripheral nerve stimulation system has now been used in a case of complex regional pain syndrome. (NeuroNews)

Hypoglossal Nerve Stimulation Maker Raises Equity Financing

Nov. 12, 2018 - Nyxoah has raised about $17 million in equity financing for its rechargeable hypoglossal nerve stimulation device. An application for CE mark approval is planned. (Fierce Biotech)

U.S. Regulator's Initiative Aims to Hasten Alternatives to Opioids

Nov. 9, 2018 - The U.S. FDA reported robust interest in an initiative to speed alternatives to opioids, in an innovation challenge whose submissions include neuromodulation devices. (CNBC)

Interview Traces an Evolution in Neuromodulation for Pain Relief

Nov. 8, 2018 - In an interview about the future of neuromodulation, Peter Staats, MD, a member of the International Neuromodulation Society, comments about the opportunity to avoid or minimize use of opioids for pain. (Pain Medicine News)

Review Considers Mechanisms of Action for Spinal Cord Stimulation

Nov. 8, 2018 - A review article proposes that the dorsal horn is a crucial site of action for spinal cord stimulation, and that dorsal islet cells may mediate its effects. (European Journal of Pain)

Outpatient Reimbursement Rate Set by CMS for Visual Prosthetic

Nov. 8, 2018 - The Centers for Medicare & Medicaid Services (CMS) set a 2019 outpatient-procedure reimbursement rate for Second Sight Medical's Argus II retinal prosthesis system of $152,500. (Mass Device)

Researchers Publish Research Into Brain Activity Patterns Associated with Mood Changes

Nov. 8, 2018 - A study published in Cell provides data indicating brain network activity associated with mood change. (Scientific American)

Non-Invasive Brain Stimulation Study Explores Effect on Chronic Low Back Pain

Nov. 8, 2018 - In a randomized, crossover, double-blind, sham-controlled pilot study in the Journal of Pain, presented at the annual meeting of the Society for Neuroscience, researchers investigated transcranial alternating current stimulation to target and enhance alpha oscillations in the somatosensory cortex of people with chronic lower back pain. (EurekAlert)

U.K. Man's Post-Traumatic Stress Syndrome Improved with Transcranial Magnetic Stimulation

Nov. 8, 2018 - A news feature describes the experience of a man who had complex post-traumatic stress syndrome for 24 years, which improved through repetitive transcranial magnetic stimulation. (Yorkshire Post)

Health Canada Approves Marketing of Patient Controller for Sacral Neuromodulation System

Nov. 7, 2019 - Health Canada has approved marketing of an external trial system for Axonics Modulation Technologies' rechargeable sacral neuromodulation system. (Business Wire)

Amputee's Prosthetic Hand Provides a Sense of Touch

Nov. 6, 2018 - An article describes the experience of the first hand amputee to receive a prosthesis that interfaces with sensory nerves to provide a sense of touch and grasp force. (FIU News)

Presentations Feature Neural Prosthetic and Rehabilitation Research

Nov. 6, 2018 - Presentations at the Society for Neuroscience dealt with neural stimulation systems for prosthetics and rehabilitation training to address blindness, amputation, stroke, and hand paralysis. (Science Daily)

Vestibular Electrical Stimulation is Being Explored to Restore Balance to Military Veterans

Nov. 5, 2018 - Researchers studying the effect of vestibular electrical stimulation on military veterans with balance deficits added an electrical noise pattern. They compared vets with healthy subjects to explore the potential therapeutic approach. (Science Daily)

A Reimbursement Coverage Decision Will Affect Phrenic Nerve Stimulation in an Outpatient Setting

Nov. 6, 2018 - The U.S. Centers for Medicare and Medicaid Services plans to extend a reimbursement, for phrenic nerve stimulation for central sleep apnea, into an outpatient setting, beginning in January 2019. (Sleep Review Magazine)

Non-invasive Neurostimulation Device Receives Marketing Approval in Canada

Oct. 29, 2018 - Health Canada has given marketing authorization for Helius Medical Technologies' portable neuromodulation stimulator as an adjunctive aspect of physical therapy for balance deficits following traumatic brain injury. The company also announced a partnership with the Feinstein Institute for Medical Research for investigational use of the device at three rehabiliation treatment sites in New York. (Market Watch)

Device Company Prices Its Initial Public Offering

Article Surveys Advances in Neurostimulation Therapy for Chronic Pain

Oct. 24, 2018 - An article provides an overview of several different options or advances among implantable or minimally invasive neurostimulation devices for chronic pain, including their potential mechanisms. (Current Anesthesiology Reports)

Case series: Early Vagus Nerve Stimulation in Children with Treatment-Resistant Epilepsy

November 2018 - In a review of 45 consecutive cases of children being implanted before the age of five (14) or after (31), with a mean follow-up of about five years, authors found early implantation led to improved cognition and quality of life. They saw no differences in seizure reduction rates or reduction of antiepileptic drugs between the two groups. (Epilepsy & Behavior)

Waiting Patients Seek Increased Access to Deep Brain Stimulation in British Columbia

Oct. 29, 2018 - Access to deep brain stimulation (DBS) surgery in British Columbia came up during a question period in the provincial legislature. An article about patients with Parkinson's disease describes how one who received it enjoys its benefits, while others who have been waiting up to three years worry their progressive disease will worsen until their therapeutic window of opportunity has closed. The provincial health minister said the number of scheduled interventions has increased from 23 to 36 this year. He added that the health authorities are working to set up the infrastructure for a second surgeon to start performing the procedure. (CBC)

FDA Approval Announced for an Aspect of Intrathecal Drug Delivery

Oct. 25, 2018 - Medtronic announced FDA approval of an aspect of its SynchroMed II intrathecal drug delivery device, myPTM Personal Therapy Manager, which permits patients to deliver a bolus of pain medication, within therapeutic limits set by their physician. (NeuroNews)

Laboratory Project Demonstrates Converting Fiber Optics to Electrical Signal to Stimulate Neurons

Oct. 25, 2018 - In a published study, scientists demonstrated converting a light pulse delivered by an optical fiber to an electrical signal to stimulate neurons in acute hippocampal brain slices of a mouse or rat. They say a potential therapeutic advantage is that the neurons do not need genetic modification, as is required in optogenetics, to respond to the stimulus. (Photonics)

In a Small Study, Noninvasive Vagus Nerve Stimulation Reduced Lupus Pain

Oct. 20, 2018 - A sham-controlled safety and efficacy study of 12 lupus patients found that four daily sessions of vagus nerve stimulation delivered through the ear, using a proprietary external device, led to reduced pain scores after five days and 12 days. The results will be presented at the American College of Rheumatology/Association of Rheumatology Professionals annual meeting. (EurekAlert)

Study: Noninvasive Brain Stimulation Improved Response to Threat in Individuals with Anxiety

Oct. 17, 2018 - In a small randomized, placebo-controlled clinical trial of 16 women with anxiety, a single session of transcranial direct current stimulation to the prefrontal cortex improved control of limbic threat reactivity, suggesting a mechanism that may underlie noninvasive brain stimulation for affective disorders. The stimulation reduced amygdala fear signaling and increased frontoparietal attentional control, thereby reducing attentional capture by threat. (JAMA Psychiatry)

Company Completes Enrollment for Pilot Study of Vagus Nerve Stimulation in Rheumatoid Arthritis

Oct. 16, 2018 - SetPoint Medical announced it has completed enrollment of 14 patients in a U.S. pilot study to evaluate the safety and tolerability of its vagus nerve stimulator for rheumatoid arthritis that has not improved through multiple different biologic therapies. (P&T Community)

U.S. Department of Defense Gives $1.3 Million Research Grant to Study Neurostimulation to Minimize Ischemic Damage after Traumatic Brain Injury

Oct. 16, 2018 - A researcher at the Feinstein Institute for Medical Research has received $1.3 million from the U.S. Department of Defense's "Foundational Research for Autonomous, Unmanned, and Robotics Development of Medical Technologies (FORwARD)" program for research into trigeminal nerve stimulation to increase cerebral blood flow and cerebrovasodilation to minimize "secondary injury" from ischemia and hypoxia following traumatic brain injury, as explained in a 2017 paper. (NewsDay)

Presentation: Improvements Seen After Dorsal Root Ganglion Stimulation

Oct. 15, 2018 - Data presented at the annual meeting of the American Society of Anesthesiologists regarding 67 patients with chronic back and leg pain noted clinical improvements after dorsal root ganglion stimulation. The patients were followed for up to 18 months. (Healio)

First UK Patient Receives Neurostimulation Implant in Clinical Trial of Heart Failure Device

Oct. 13, 2018 - An article describes the first UK patient to receive a neuromodulation implant that addresses heart failure, through an international clinical trial. The implant stimulates baroreceptors that regulate blood pressure. (Daily Mail)

Project Seeks to Develop an Adaptive Brain-Stimulation System for Obsessive Compulsive Disorder

Oct. 8, 2018 - Baylor College of Medicine is seeking research participants for an 18-month research study to classify symptoms of obsessive compulsive disorder and other mood states to develop an adaptive deep brain stimulation to treat the condition. (Baylor College of Medicine)

Article Describes Cluster Headache Patient in the United Kingdom Receiving a Neurostimulation Device Designed for Occipital Nerve Stimulation

Oct. 8, 2018 - International Neuromodulation Society member Ashish Gulve, MD, was quoted in an article in which his patient describes receiving occipital nerve stimulation in the UK for chronic cluster headache. He used a device that targets stimulation therapy to branches of the occipital nerve, the trigeminocervical complex. (Daily Mail)

Project Pursues an Electrical Stimulation System for Use after CNS Injury

Oct. 5, 2018 - A research project aims to develop an electrical stimulation system to use during the first two weeks or so following central nervous system injury, to enhance activity-dependent plasticity. The intent is to improve functional recovery in a relatively inexpensive fashion that could be adapted following spine injury or stroke. The project at Loyola University in Illinois is being supported by a $500,000 charitable grant. (EurekAlert)

U.S. Department of Defense Helps Fund Development of Percutaneous Pain Relief Implant

Oct. 3, 2018 - SPR Therapeutics announced it has received $10 million in a contract and two clinical trial grants from the U.S. Department of Defense. The support will fund development of its percutaneous peripheral nerve stimulation therapy for acute and chronic pain relief. (Mass Device)

Proposed Insurance Changes in Australia Raise Concerns about Access to Neuromodulation Therapy

Oct. 1, 2018 - International Neuromodulation Society member Marc Russo, MD, was quoted in news coverage about a proposed change to private insurance in Australia that would limit access to medical device implants for pain to only the highest level of coverage. (The World Today)

Reviewers Publish Guidance on Dorsal Root Ganglion Stimulation

Sept. 24, 2018 - In a review article, the Neuromodulation Appropriateness Consensus Committee issued guidance about the use of dorsal root ganglion stimulation, an evolving method, for chronic neuropathic pain. The committee's review covers indications, such as CRPS or groin pain, and unique considerations for lead placement and programming. An accompanying chart shows suggested levels for stimulation, based on the pain location. (Neuromodulation: Technology at the Neural Interface)

Paralyzed Patient Stands Alone and Takes Steps after Rehabilitation with Epidural Spinal Cord Stimulation

Sept. 24, 2018 - Nature Medicine reported how a spinal cord injury patient was able to stand and walk with assistance during a year-long course of rehabilitation augmented by epidural spinal cord stimulation. Mentioning this work in the U.S., an article in Australia discusses hope for similar programs to start there next year. (Science Daily)

Company Announces Minimally Invasive Implant of "Electroceutical" Device

Sept. 18, 2018 - MedAutonomic announced the first implant of its neurostimulation device in the stomach wall of a human patient. The device is implanted with a gastric endoscope and is designed to be powered by piezoelectric energy harvested by the "tail" of the device. The device is intended to balance autonomic nervous system function to treat conditions such as type-2 diabetes, hypertension, and gastroesophageal reflux disease. (Mass Device)

Company's Spinal Cord Stimulation System Approved in Australia

Sept. 19, 2018 - Nevro Corp.'s Senza II spinal cord stimulation system has received approval in Australia from the Therapeutic Goods Administration. (Neuro News)

Company Begins Clinical Trial of Vagus Nerve Stimulation in Heart Failure

Sept. 18, 2018 - LivaNova announced it has launched a pivotal study of its vagus nerve stimulation device for heart failure, with the first implant completed in Iowa. The multi-center Anthem-HFrEF study will have up to 800 participants through the year 2022. They will be randomized 2:1 to receive the implant or standard medical care. (Mass Device)

Medical Center's New $20 Million Grant Will Help Fund Research Into Brain Stimulation to Treat Depression

Sept. 18, 2018 - The University of California, San Francisco has received a $20 million grant from the family of audio pioneer Ray Dolby. With this funding, the medical center will seek to start a brain-stimulation clinical trial in 2019. Using a network of electrodes on the surface of the brain, the study will investigate identifying and targeting dysfunctional brain circuits to treat depression. (The Mercury News)

Report: Epidural Spine Stimulation Improved Blood Pressure and Heart Rate Regulation in Spine Injury Patients

Sept. 17, 2018 - Research at the University of Louisville's Kentucky Spinal Cord injury Research Center, published in JAMA Neurology, described improvements four spine-injured patients experienced in blood pressure and heart rate regulation, after receiving spinal cord epidural stimulation. (EurekAlert)

Scientists Elucidate a Pain Circuit That Might Be a Therapeutic Target

Sept. 12, 2018 - In research that might eventually help to better target pain therapies such as spinal cord stimulation, scientists showed that particular cortical neurons in a mouse brain were responsible for amplifying painful sensations that are elicited by touch. The scientists think the feedback circuit formed by these neurons, which send projections to the dorsal horn, might be a target for treating the tactile component of neuropathic pain. (EurekAlert)

Non-invasive Brain Stimulation Therapy Will Come to Zimbabwe

Sept. 12, 2018 - An article says repetitive transcranial magnetic stimulation therapy will be available at a private clinic in Zimbabwe by the end of the year. (Zimbabwe Daily)

Study Adds Evidence for Transcranial Magnetic Stimulation to Address Drug Withdrawal

Sept. 12, 2018 - A sham-controlled study of transcranial magnetic stimulation in 48 men with methamphetamine addiction showed that 10 sessions of stimulation to the left dorsal-lateral prefrontal cortex curbed withdrawal symptoms, such as craving, anxiety, depression and sleep difficulties. (Healio)

Researchers Show Dopamine Sensors Function Over One Year in Laboratory Animals

Sept. 12, 2018 - Scientists report they have been able to use implanted electrodes to record dopamine levels for more than a year in the brains of laboratory rats. The implants, measuring 10 microns across, did not have evidence of surrounding tissue changes indicative of an immune reaction. (MIT News)

Family Shares Their Experience Treating Genetic Disorder with Deep Brain Stimulation

Sept. 12, 2018 - An article about a young woman with a genetic condition, Kleefstra syndrome, describes her experience managing some of its behavioral issues, such as tics and obsessive-compulsive behavior, with deep brain stimulation. (Spectrum)

Article Gives a First-Hand Perspective About Spinal Cord Stimulation for Chronic Pain

Sept. 10, 2018 - In a first-person account about receiving a spinal cord stimulation system for chronic pain, a freelance writer provides context about chronic pain and neuromodulation treatments. Her article includes comments about the evolution of the field, and patient response to treatment, from International Neuromodulation Society president Timothy Deer, MD. (Popular Science)

Study Finds Improvements in Restless Leg Syndrome in Parkinson's Patients Who Have Deep Brain Stimulation Therapy

Sept. 10, 2018 - A retrospective study of 22 patients with Parkinson's disease, who received subthalamic nucleus deep brain stimulation surgery, showed improvements in symptoms of restless leg syndrome regardless of changes in their Parkinson's disease motor symptoms or medications. (Neurology Advisor)

Study Examines Differences in Response to Spinal Cord Stimulation in Smokers and Non-Smokers

Sept. 5, 2018 - International Neuromodulation Society member Nagy Mekhail, MD, and colleagues published findings that among 213 pain patients, 12 months after receiving a spinal cord stimulator, smokers had higher pain scores than non-smokers or former smokers, and higher opioid pain medication use. The authors undertook the retrospective cohort study based on the hypothesis that smoking diminishes the analgesic response to spinal cord stimulation. (Regional Anesthesia and Pain Medicine)

Study Demonstrates Feasibility of Decoding Mood Variations from Neural Activity

Sept. 10, 2018 - Collaborators have published results of a feasibility study of mood state decoding. The researchers used data from seven patients who were undergoing brain-activity monitoring for epilepsy. They demonstrated that mood state variations can be decoded over time from neural activity. (EurekAlert)

U.K. Private Clinic to Offer New Neurostimulator for Chronic Disabling Low Back Pain

Sept. 9, 2018 - An article announces that a day surgery clinic is the first in England to offer a new type neurostimulator for chronic lower back pain. The device underwent successful trials through the National Health Service, and is available to private-pay patients. (Chelmsford & Mid Essex Times)

Pilot Study Finds Evidence for Posterior Tibial Nerve Stimulation to Improve Female Sexual Dysfunction

Sept. 5, 2018 - Researchers published findings that nerve stimulation treatment used to treat bladder dysfunction might improve sexual function among women. After tests in rats showed increased blood flow from transcutaneous electrical nerve stimulation (TENS) in the genital region or ankle, the researchers recruited nine women with sexual dysfunction, who received 12 sessions of TENS. Eight of the women reported improvements that were as good, or better, than prior studies of different types of drugs or neuromodulation for the condition. (UPI.com)

Insurer to Cover Dorsal Root Ganglion Stimulation

Sept. 4, 2018 - Health insurer Aetna has decided to provide national reimbursement coverage for the Proclaim dorsal root ganglion stimulator for neuropathic pain, opening up the therapy to about 22 million health plan members in the U.S.. An article notes that the FDA-approved device is also covered by Medicare, and other major health insurers are evaluating their coverage decisions. (Star Tribune)

Company Requests FDA Clearance for Non-invasive Device to Address Balance Issues Due to Traumatic Brain Injury

Sept. 4, 2018 - Helius Medical Technologies, Inc. is requesting an FDA de novo classification and 510(k) clearance of its Portable Neuromodulation Stimulator (PoNS™) device for the treatment of chronic balance deficit due to mild- to moderate-traumatic brain injury. (P&T Community)

Study Evaluates Dorsal Root Ganglion Stimulation Over 12 Months

Aug. 31, 2018 - International Neuromodulation Society member Frank Huygen, MD, PhD, and colleagues have published results of dorsal root ganglion stimulation in patients who were followed for 12 months. The study, which appears in Neuromodulation: Technology at the Neural Interface, enrolled 66 patients at three centers in 2012 - 2013. Permanent implants were placed in 56 of the patients, who had a variety of pain diagnoses. After 12 months, 82% of the patients achieved at least a 30% reduction in pain scores, with 49% experiencing a reduction of 50% or more. The authors noted the patients had increases in functional capacity, mood, and quality of life. (NeuroNews)

Company Pursues Development of Small, Wireless, Networked Neurostimulators

Aug. 30, 2018 - Draper Laboratory is developing implantable neurostimulation systems, 1 cubic centimeter in size, that communicate wirelessly and are wirelessly powered. The company says the implants can interface with multiple types of electrodes, and are designed to not need leads and connectors. The company cited a potential for either brain or peripheral implantation. Each neurostimulator has 32 channels for recording and stimulation. The announcement says applications could include implanting up to four networked neurostimulators. (Cision)

Company Announces 36-Month Follow-Up for Overactive Bladder Patients Who Received Tibial Nerve Stimulation

Aug. 30, 2018 - BlueWind Medical announced that in a 36-month follow-up of 20 patients who were implanted with the company's tibial nerve stimulator for overactive bladder, 75% of them experienced at least a 50% improvement in overactive bladder symptoms. (BioSpace)

Study Finds Evidence for Intrathecal Baclofen in Patients with Severe Post-Stroke Spasticity

Aug. 27, 2018 - International Neuromodulation Society member Michael Creamer, DO, and colleagues have published results of secondary outcome measures from the Spasticity In Stroke–Randomized Study (SISTERS) that compared patients with severe post-stroke spasticity who received either intrathecal baclofen (ITB) or conventional medical management. The phase 4 study included 60 patients at centers in Europe and the U.S. The authors concluded that the patients who received ITB therapy had comparative improvements in pain and quality of life. (Stroke)

Researchers Identify Conditions for Re-Growth of Axons in Spine-Injured Laboratory Animals

Aug. 29, 2018 - Researchers have demonstrated re-growth of axons across a complete spinal cord injury in mice and rats. The new pathways exhibited some ability to conduct electrical activity upon stimulation. The research was published in Nature magazine. (R&D Magazine)

Review Assesses Cervical Vagus Nerve Stimulation for Primary Headache Disorders

Aug. 27, 2018 - International Neuromodulation Society member Thomas Kinfe, MD, PhD, and colleagues have published a review that evaluates invasive and noninvasive stimulation of the cervical branch of the vagal nerve for episodic or chronic migraine and cluster headache. They conclude that response to noninvasive vagus nerve stimulation seemed most favorable in episodic headache subtypes. (Dove Press)

Study: Vagus Nerve Stimulation Led to Improved Quality of Life Scores for Patients with Depression

Aug. 27, 2018 - A study published in the Journal of Clinical Psychiatry compared 328 patients with depression who had implanted vagus nerve stimulators, and 271 patients who only received treatment as usual. The patients who received vagus nerve stimulation had significant gains in quality of life, such as mood, ability to work, social relationships, family relationships and leisure activities. (China.org.cn)

Article Heightens Awareness of Spinal Cord Stimulation

Aug. 25, 2018 - An article about spinal cord stimulation says Leeds Teaching Hospital NHS Trust is gathering new data to be presented later this year. International Neuromodulation Society member Ganesan Baranidharan, MBBS FRCA FCARCSI, was quoted as describing how life-altering the treatment can be. (Daily Mail)

Project to Reconnect Nerves following Spinal Cord Injury Receives $3.5 Million European Research Grant

Aug. 24, 2018 - The European Commission’s Horizon 2020 Future and Emerging Technologies program has granted $3.5 million over four years for a prototype ByAxon device to bridge a spinal cord injury, and reconnect nerves on either side. The ByAxon project began in 2017 in an interdisciplinary consortium of research institutions from Spain, France, Italy and Germany. (Healthcare IT)

Company Announces Launch of Device Registry for Neurostimulator for Drug-Resistant Epilepsy

Aug. 23, 2018 - LivaNova PLC announced it has launched a registry to evaluate its vagus nerve stimulation system in patients with drug-resistant epilepsy. Patients at up to 80 sites will be followed for up to five years, to document seizure frequency, seizure severity, quality of life, quality of sleep, antiepileptic drug use, and seizure-related emergency visits and hospitalizations. (Business Wire)

Researchers Use Laboratory-Cultured Neural Tissue to Study Potential Electrical Stimulation Effects Following Traumatic Brain Injury

Aug. 23, 2018 - Researchers at the University of Georgia have replicated the effects of traumatic brain injury and recovery in stem-cell-derived neurons, using glutamate and electrical stimulation. In a concussion-like effect, glutamate disrupted synchronous activity of the cultured neural tissue. Then, dozens of miniature electrodes arrayed on the laboratory culture dish were used to stimulate recovery. The observations may help the researchers devise ways to guide stimulatory patterns -- at multiple levels of individual neurons, neural tissue, and the brain -- to ultimately develop wearable therapeutic stimulation devices. (Science Daily)

Review Summarizes First-line Options for Intrathecal Therapy for Chronic Pain

Aug. 22, 2018 - International Neuromodulation Society members Timothy Deer, MD; Jason Pope, MD; Michael Hanes, MD; and Gladstone McDowell, II, MD have published a review of first-line medication options for intrathecal therapy for chronic pain. The article summarizes recommendations of the 2016 Polyanalgesic Consensus Conference (PACC), and draws upon more than 100 published studies regarding non-cancer pain and cancer pain. In conclusion, the authors reiterate PACC guidelines that recommend morphine and ziconotide as first-line monotherapy for cancer-related and non–cancer-related pain. (Pain Medicine)

Non-Invasive Stimulation Helped Spine-Injury Patients Improve Bladder Control

Aug. 22, 2018 - Investigators report in Scientific Reports a double-blinded, crossover study in which five spinal-cord injury patients improved bladder control after four months of weekly transcutaneous magnetic stimulation sessions to the lower spine, administered at 1 Hz using a device that is normally used for transcranial magnetic stimulation treatment. The researchers said the benefit lasted up to two weeks post-stimulation. The stimulation targeted the T12-L1 level of the spine, over the conus medullaris. (Health Day)

Company Announces FDA Approval of Shorter Sessions for Transcranial Magnetic Stimulation

Aug. 22, 2018 - MagVenture announced the FDA has approved a new transcranial magnetic stimulation protocol using its device for treatment of drug-resistant major depressive disorder. The protocol relies on intermittent theta-burst stimulation. Under the new protocol, sessions last about three minutes, rather than 20-30 minutes. (Medscape)

Study: Non-invasive Neurostimulation Improved Symptoms of Neurodegenerative Ataxias

Aug. 22, 2018 - Researchers report in Neurology a randomized, double-blind, sham-controlled crossover trial of transcranial magnetic stimulation (tDCS) in 20 patients with neurodegenerative ataxias. The patients' symptoms improved for up to three months after receiving tDCS for five days a week for two weeks. (EurekAlert)

Researchers Investigate Non-invasive Stimulation in Speech Therapy for Post-Stroke Aphasia

Aug. 20, 2018 - A double-blind randomized clinical trial of transcranial direct current stimulation in stroke patients with aphasia showed that combining the treatment with speech therapy nearly doubled the number of words patients were able to name correctly, compared to sham; 13.9 words for the group that received stimulation vs. 8.3 words for the sham treatment group. The researchers plan a larger trial and plan to publish a follow-up paper about genetic differences related to tDCS response. (MedPage Today)

Article Describes Planned Study of Vagus Nerve Stimulation in Gastric Disorders

Aug. 20, 2018 - A sham-controlled clinical trial at Massachusetts General Hospital will involve a single session of non-invasive vagus nerve stimulation of a branch of the vagus nerve on the earlobe. The study participants will have MRI brain scans and tests of electrical activity in the gut after having eaten a meal to assess effects of the stimulation. The study will investigate effects on gastroparesis and indigestion in 50 patients. (Daily Mail)

Company's Non-Invasive Stimulation System Cleared by FDA for Marketing for Obsessive Compulsive Disorder

Aug. 17, 2018 - The FDA has granted marketing clearance for treatment of obsessive compulsive disorder with a deep transcranial magnetic stimulation system by Israel-based Brainsway Ltd. The clearance for the non-invasive treatment was issued through a "de novo" approval pathway meant for low- to moderate-risk devices. (Medscape)

Percutaneous Peripheral Nerve Stimulation Systems for Pain Receive FDA Clearance

Aug. 16, 2018 - SPR Therapeutics' SPRINT peripheral nerve stimulation systems have received FDA clearance for use in pain management, the company announced. The company has single-lead and dual-lead percutaneous devices that are charged by a wearable pulse generator. The company said the systems are indicated for use for up to 60 days in the back and/or extremities for chronic and acute pain. (Medscape)

Neuromodulation Company Addressing Vision Loss Announces $5 Million Private Placement

Aug. 16, 2018 - Second Sight Medical announced a private placement in which it is selling about 3.2 million shares of common stock for $1.55 a share to entities owned by its board chair Gregg Williams. The net proceeds of about $5 million will will help support continued development, studies, and evidence-collection for its visual prosthesis systems and devices. (Mass Device)

Laboratory Project Would Demonstrate a Nervous System Implant that Combines Electrical, Chemical, Thermal, and Optical Functionalities

July 31, 2018 - A five-year, 1.5 million Euro project to develop neuroprosthetic implants for the brain with electrical, chemical, thermal and optical modes has been approved by the European Research Council at the Dresden University of Technology. The project, known as Integrated Implant Technology for Multimodal Brain Interfaces (IntegraBrain), will begin with demonstration in rats of a cortical interface to control focal seizures, and a peripheral nerve interface to control visceral function. (TU Dresden)

Company Announces a 4-Year, $1 Million Preclinical Research Collaboration on Non-Invasive Vagus Nerve Stimulation and Neuroinflammation  

Aug. 9, 2018 - The company electroCore, Inc. announced it has entered a preclinical research partnership with Massachusetts General Hospital to study the mechanisms of inflammatory processes associated with central nervous system conditions, such as pain, trauma, and neurodegredation. The company will provide up to $1 million over four years for the studies, including two recently begun studies on non-invasive vagus nerve stimulation (VNS). One study focuses on persistent neuroinflammation and the neurological outcomes after concussive traumatic brain injury; the other, on effects on microglia cells and their association with the development and progression of Alzheimer’s disease. Previously, the company supported preclinical investigations at the same institution regarding neuroinflammatory mechanisms associated with migraine and their modulation by non-invasive VNS. (Globe Newswire)

Manitoba Clinic Seeks Participants for Study of Repetitive Transcranial Magnetic Stimulation in Depression

Aug. 8, 2018 - A Manitoba, Canada clinic will participate in a clinical trial of repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant depression. The article states that although the provinces of Quebec and Saskatchewan cover rTMS for mood disorders, Manitoba Health decided against covering it in 2016. The clinic opened in 2012 and has a six-month waiting list. Its management has been fundraising and applying for grants to help cover costs for patients who cannot afford to pay for the treatment. (CBC)

Paper Presents Data on the Use of Deep Brain Stimulation in Meige Syndrome

Aug. 7, 2018 - In a two-patient case study of deep brain stimulation of the globus pallidus interna to address disabling muscle contractions of Meige syndrome, the authors in the U.K. and Portugal included a literature review of 82 cases, with pooled data showing a 60% improvement at a mean follow-up of about five years. The two patients in the case study were followed for two years, and improved motor symptoms of their craniocervical dystonia. (Neurology Advisor)

Large Dataset Analysis: From 57 - 72% Success for Sacral Nerve Stimulation Trials

Aug. 5, 2018 - An analysis of 1,396 patients who were trialed for a sacral nerve stimulation system from 2005 - 2011 in California found trial success rates of 72% for overactive bladder, 69% for urgency/frequency, 68% for interstitial cystitis, 67% for neurogenic bladder, and 57% for urinary retention. The analysis used non-public data from the California Office of Statewide Planning and Development's ambulatory surgery database. The article noted that although the rates were less than at some academic centers, they were better than previously reported tor Medicare beneficiaries. (Uro Today)

Percutaneous Neurostimulation Model for Overactive Bladder Investigates Activation of Saphenous Nerve  

Aug. 4, 2018 - Researchers explored the extent to which percutaneous tibial nerve stimulation co-activates the adjacent saphenous nerve, which animal studies indicate can evoke a bladder-inhibitory reflex. In their finite element model, they determined the electrode location and stimulation amplitude were important variables. (Uro Today)

Panel Evaluates Appropriateness of Treatment Options for Persistent Pain After Surgery

July 25, 2018 - Eight members of the International Neuromodulation Society are among the 19 neurosurgeons, pain specialists, and orthopedic surgeons who assessed appropriateness of four treatment options for 210 clinical scenarios of persistent pain after back surgery. The four treatment options were conservative, minimally invasive, neurostimulation, and re-operation. Neurostimulation was considered appropriate for predominant neuropathic leg pain in the absence of conditions that may require surgical intervention. (European Spine Journal)

Visual Prosthetics Company Reports Regulatory and Clinical Progress

Aug. 7, 2018 - Second Sight Medical Products, Inc. included updates on research and technical advances in its quarterly report for the second quarter of 2018. The company received FDA permission for a 6th feasibility subject to be implanted with its Orion™ Cortical Visual Prosthesis System. All five implanted subjects are experiencing spots of light via cortical stimulation, and one is close to being cleared for home use to begin an artificial vision rehabilitation process. The company is continuing to refine its external visual prosthetic in developing the Argus® 2s. This includes research into integrating eye-tracking and object recognition with artificial vision. The Argus II system has received a 2019 preliminary Medicare average outpatient payment rate of approximately $137,500. In the second quarter of 2018, gross profit was $1.1 million and per share, there was a net loss of $0.12. Both figures were unchanged from one year ago.  (Business Wire)

Retrospective Analysis Evaluates Factors Affecting Success of Dorsal Root Ganglion Stimulation Trials

Aug. 7, 2018 - In a physician-initiated analysis, 14 members of the International Neuromodulation Society looked for factors affecting the success of trialing dorsal root ganglion stimulation in 217 chronic pain patients in the U.S. Roughly half the patients (104) had a diagnosis other than complex regional pain syndrome. The authors found the treatment is most effective in focal neuropathic pain, especially in the distribution of a specific peripheral nerve. The most significant determinant of response was paresthesia coverage. For that reason, the authors recommend using at least two leads for the area being treated. (Neuromodulation: Technology at the Neural Interface)

Device for Central Sleep Apnea Receives Approval for Technology Add-On Payment from the Centers for Medicare and Medicaid Services

Aug. 6, 2018 -  Respicardia, Inc. announced the Centers for Medicare and Medicaid Services approved a new technology add-on payment for its tranvenous phrenic nerve stimulation system to reduce the severity of central sleep apnea through activating the diaphragm during sleep. The additional reimbursement will go into effect Oct. 1, 2018. (Markets Insider)

Study: Three-dimensional Target Mapping Aided Brain Stimulation Efficacy

Aug. 3, 2018 - Three-dimensional subthalamic nucleus mapping led to better 12-month outcomes in Parkinson's disease patients who underwent deep brain stimulation surgery, according to a randomized controlled study of 76 patients in Oslo. The cohort who had multiple microelectrode recordings to optimize lead placement did better than the control group whose target stimulation was guided by single sequential microelectrodes. (Neurology Advisor)

Case Series: Pelvic Pain Patients Responded to Novel Neurostimulation Configuration

Aug. 1, 2018 - International Neuromodulation Society members Corey Hunter, MD, and Ajax Yang, MD, published a case series in Neuromodulation: Technology at the Neural Interface concerning seven patients with chronic pelvic pain who were successfully trialed with neurostimulation leads placed over the bilateral L1 and S2 dorsal root ganglia. The patients' conditions had been resistant to conventional treatment, the the lead configuration was intended to cover the upper and lower part of the painful pelvic area. The report says that so far, four of the patients received implants between 3 - 12 months ago, and continue to experience pain relief, treatment satisfaction, and functional improvement. (Neuromodulation: Technology at the Neural Interface)

Paper Presents Hypothesis for Pathophysiology of Complex Regional Pain Syndrome, Suggests Investigating Immunomodulatory Interventions

July 27, 2018 - International Neuromodulation Society members Marc Russo, MBBS DA(UK)FANZCA, FFPMFANZCA, and Peter Georgius, MBBS, FFPMANZCA, FAFRM, have published an open-access paper in Medical Hypotheses with Danielle Santarelli, PhD, with a hypothesis for the pathophysiology of complex regional pain syndrome (CRPS). They say CRPS might best be considered a dynamic, multi-component disease with immune-neurological elements. They suspect an underlying factor could be activation and subsequent overactivity of dendritic cells, which are responsible for immunosurveillance. They present four components whose extent and impact likely varies from patient to patient: tissue trauma, abnormal pain processing, autonomic dysregulation, and immune system alteration. They conclude that a new research area to explore could be inhibition of inflammatory dendritic cell activation, such as through administering immunomodulatory drugs, or possibly, vagus nerve stimulation. (Medical Hypotheses)

Deep Brain Stimulation System Receives Expanded MRI-Conditional Approval

Aug. 2, 2018 - Abbott said it has received expanded FDA approval for MRI-conditional labeling of its Infinity deep brain stimulation system. The expansion comes in conjunction with a wireless software update. (Mass Device)

Winner Announced for 2018 Science & PINS Prize for Neuromodulation

Aug. 2, 2018 - The winner and finalist for the Science & PINS Prize for Neuromodulation have been announced. The winner receives $25,000. Both the winner and finalist have the essays they submitted for the competition published in Science magazine. Nir Grossman, PhD, of the Imperial College London, is the 2018 winner. His essay described research into non-invasively stimulating subcortical brain structures through applying multiple electric fields at slightly different frequencies within the kHz range. This creates temporal interference that allows a stimulating field to penetrate more deeply. The stimulation location can be guided by altering the relative amplitude and orientation of the applied field. Having demonstrated the work in mice, he said deep brain stimulation is more narrowly localized, and suggested that a subdural version of the new approach might be considered. The finalist, Aryn Gittis, PhD, of Carnegie Mellon University, wrote an essay about potentially being able to repair neural circuit dysfunction, as suggested by optogenetic experiments in a mouse model of Parkinson's disease, through stimulation of a subset of neurons in the external globus pallidus. (EurekAlert)

Health Canada Approves a Spinal Cord Stimulation System

Aug. 1, 2018 - Medtronic plc announced its Intellis spinal cord stimulator has received approval from Health Canada. (Mass Device)

Company Launches Second-Generation Non-invasive Vagus Nerve Stimulator

Aug. 1, 2018 - The company electroCore announced it is launching its second-generation non-invasive vagus nerve stimulator, gammaCore Sapphire. In July, the company entered the migraine market in the U.S., the announcement noted. The second-generation device is activated each month by an RFID card, similar to a hotel key card. The company said its business model calls for charging a monthly fee for the device. The announcement added that the company may later explore applications in neurology and rheumatoid arthritis. (MD+DI)

Article Presents Neurostimulation Devices as an Alternative to Opioids

July 31, 2018 - International Neuromodulation Society member Nagy Mekhail, MD, PhD, was quoted in an article explaining how medical devices such as spinal cord stimulators can help address neuropathic pain without reliance on opioids. The article said companies have been developing and refining technologies to offer pain relief without dependence on addictive painkillers, as well as an externally worn stimulation system to minimize opioid withdrawal symptoms. (Technology Review)

Stimulation Method Aims to Modify Underlying Disease

July 25, 2018 - A news feature says bioelectronic medicine is intended to modify underlying disease through brief daily stimulation of a few minutes or less. The article explains the emerging field is being initially explored to address inflammatory, metabolic, and endocrine disorders. (MD+DI)

Parkinson's Disease Patient with Neuropathy Reduces Reliance on Pain Medication After Spinal Cord Stimulation, Improves Mobility

July 26, 2018 - International Neuromodulation Society member Frank McDonnell, MD was quoted in a news segment about a Parkinson's disease patient with peripheral neuropathy who reduced his need for opioids and pain medication through use of a spinal cord stimulator that also improved the tremor from his movement disorder. The patient said he could resume activities he used to enjoy and get around again without relying on a walker. (www.14news.com)

Project Endeavors to Create a Brain-Stimulation Helmet

July 24, 2018 - The Xinhua news agency reported that scientists and engineers in Shenzhen are working on a brain-stimulation helmet to enhance brain function, emotional regulation, and memory through brain stimulation. The device monitors brainwaves and provides cortical stimulation, and eventually, may provide deeper stimulation. The article says a prototype device that incorporates artificial intelligence technology has been demonstrated to enhance performance on a memory task by volunteers. (Health Thoroughfare)

Non-invasive Brain Stimulation Aided Memory Performance

July 23, 2018 - In a sham-controlled study,16 people trained to detect targets in complex visual scenes performed better on a related task the next day after receiving brain stimulation during sleep that matched slow-wave oscillations dominant at that time. The stimulation was delivered through a closed-loop transcranial alternating current system. Results of the study appeared in the Journal of Neuroscience. (EurekAlert)

Publication Will Report on Recent Boston Neurotech Conference

July 23, 2018 - The 13th Annual Neurotech Investing and Partnering Conference in Boston, a two-day event May in Boston organized by the Neurotechnology Industry Organization and Cambridge Healthtech Institute, will be the subject of coverage in Health Europa Quarterly in August. The event had attendees from the USA, France, Australia, Israel, Japan and Switzerland, and covered treatments for neuropathic pain, epilepsy, degenerative disease and movement disorder, mental health, and emerging technologies and companies. (Health Europa)

Wireless Stimulation Used for Laboratory Nerve-Regrowth Project

July 23, 2018 - In research with potential implications for application in people, scientists report on an approach to use stimulation for regrowth of an injured peripheral nerve. They demonstrated regrowth of a severed sciatic nerve in rats that had received a bioadhesive cuff over the injury containing a gold band. The band acted as an antenna when the rats were exposed weekly, for three months, to a magnetic field from a transcranial magnetic stimulator. The combination of a regrowth scaffold and the wireless stimulation were credited with contributing to the recovery. Typically, axon regeneration is minimal following peripheral nerve injury. (Technology Review)

Scientists Explore Modulation of Brain's Reward Circuitry and Anti-Tumor Immune Response in Mice

July 18, 2018 - Nature Communications reported stimulation of the ventral tegmental area, part of the brain's reward system, in mice led to reduction in the size and weight of tumors. The authors point out the brain circuit activated by the stimulation affects immunity, saying the stimulation apparently modulated an anti-tumor immune response. The stimulation was carried out using modified cell-surface receptors and a targeted stimulatory ligand. The researchers have begun a collaboration in Tel Aviv to see if immune effects can be triggered in humans by directly stimulating the reward circuit, according to Scientific American. (Newsweek)

Review Examines Five Decades of Research on Supraspinal Mechanisms in Spinal Cord Stimulation for Chronic Pain

July 17, 2018 - International Neuromodulation Society members Eellan Sivanesan, MD; Bent Linderoth, MD, PhD; Yup Guan, MD, PhD; and colleagues have published a review of supra spinal mechanisms in spinal cord stimulation based on clinical and preclinical studies concerning chronic pain treatment. (Anesthesiology)

Analysis: Equivalent Outcomes for Dorsal Root Ganglion Stimulation With, or Without, Paresthesia

July 18, 2018 - A subgroup analysis of 61 patients with complex regional pain syndrome who received dorsal root ganglion (DRG) stimulation demonstrated that the patients with no paresthesia generally reported equivalent or better outcomes compared to the 41 who experienced paresthesia. The data were gathered during the multicenter controlled randomized ACCURATE study that compared DRG stimulation with spinal cord stimulation. The results were presented in a poster at the 2017 annual meeting of the American Society of Regional Anesthesia and Pain Medicine. (Pain Medicine News)

Non-invasive Vagus Nerve Stimulation Company Strikes a Deal to Offer Telemedicine Screening

July 17, 2018 - Through a telemedicine program by UpScriptHealth, electroCore will offer its noninvasive vagus nerve stimulation therapy migraine and episodic cluster headache. Patients can use UpScriptHealth for a telemedicine consultation, and if the treatment is subsequently prescribed, a unit will be shipped to them. (Fierce Biotech)

Research Program Would Broaden Application of Neural Interfaces to Able-Bodied Service Members

July 17, 2018 - The Defense Advanced Research Projects Agency will be selecting teams for its Next-Generation Non-Surgical Neurotechnology, or N3, program to develop neural interfaces for members of the military to enable neural recording and stimulation for applications meant for able-bodied war fighters. (Nextgov)

Article: Transcutaneous Electrical Nerve Stimulation of the Vagus Nerve May Address Memory, Behavior Issues in Dementia

July 17, 2018 - An article summarizes research into the possibility that transcutaneous electrical nerve stimulation (TENS) of the vagus nerve may help improve memory or behavior in dementia. (Newsmedical.net)

Anorexia Nervosa Patients in Spain Offered Deep Brain Stimulation

July 12, 2018 - An article says that doctors in Spain are believed to be the first in Europe to use brain stimulation implants to treat anorexia nervosa. According to news reports, three of the four patients who were treated saw improvements in their symptoms. (Newsweek)

Sacral Nerve Stimulation Helps Spine-Injured Woman Regain Some Mobility and Function

July 11, 2018 - A young woman from Colombia whose lower back was broken 10 years ago is regaining some function in her legs and bladder after receiving a bilateral sacral nerve stimulation implant last year. Her Los Angeles-based surgeon first encountered her as a visiting professor in Bogotá. He believes she will make further progress beyond her current new ability to now stand and walk for 10 minutes at a time, with the help of leg braces. (UCLA)

Autism Study Compares Noninvasive Brain Stimulation Targets

July 10, 2018 - Australian researchers have begun a clinical trial of theta-burst repetitive transcranial magnetic stimulation in 14-30 year-olds with autism spectrum disorder. The study compares stimulation at the right temporoparietal junction and the bilateral dorsomedial prefrontal cortex, which the research team previously showed improved social relating. Up to 20 participants will be followed for 12 months. (Deakin University)

Engineering Researchers Receive Recognition for Work to Develop MRI-Compatible Neurostimulation Leads

July 10, 2018 - University researchers in New Zealand have licensed to Saluda Medical their design for neurostimulation leads that are potentially MRI-safe, according to an announcement of a New Zealand research commercialization competition. (Voxy.co.nz)

Reviewers Summarize Existing and Emerging Neuromodulation Treatments for Lower Urinary Tract Conditions

July 1, 2018 - A review summarizes the current state of neuromodulation techniques, including minimally invasive or noninvasive devices, to treat bowel or bladder conditions such as overactive bladder or pelvic pain. (Urology News)

Company Announces CE Mark of an External Trial Phase Neurostimulator

July 9, 2018 - Axonics Modulation Technologies, Inc. has received CE mark for its external sacral nerve stimulation (SNS) trial system. The company's small rechargeable SNS therapeutic implant is being launched commercially in the U.K. to address overactive bladder. Meanwhile, the company has completed the enrollment and implant phase of a 120-patient pivotal clinical study in the U.S. The announcement noted that payers prefer to reimburse implant proceduress after confirming that a patient has responded to a trial phase. (Business Wire)

Device Maker Reports Progress in Clinical Trial in Chronic Disabling Low Back Pain

July 9, 2018 - Mainstay Medical International plc announced completion of all implants in its U.S. clinical study of its  implantable restorative neurostimulation system to treat disabling chronic low back pain. A total of 204 patients were implanted in the multi-center, prospective, randomized, controlled trial. Resulting data are expected to be reported at the end of 2018. (Business Wire)

Device Company Receives $108 Million in Initial Public Offering

July 6, 2018 - Neuronetics, Inc. has raised $107.5 million in an initial public offering. The company markets the NeuroStar transcranial magnetic stimulation system for treatment of medication-resistant depression. (Mass Device)

Collaborators Demonstrate Recording Brain's Response to Electrical Simulation

July 6, 2018  - Researchers demonstrated a proof-of-concept system that was created through a collaboration to record the brain's response to electrical stimulation.(IEEE Spectrum)

Woman is Reportedly the First in Her State in India to Receive a Spinal Cord Stimulator for Chronic Pain

July 4, 2018 - A 59-year-old woman with postherpetic neuralgia affecting her chest is said to be the first patient in the Indian state of Kerala to be implanted with a spinal cord stimulator to manage her chronic pain. (New Indian Express)

Compound Might Enable Therapeutic Neuromodulation Through Magnetomechanical Stimulation

June 27, 2018 - Researchers have reported in Advanced Materials creation and neural testing of a 3D magnetic hyaluronic hydrogel they say can be developed as a biomaterial to provide remote neuromodulation via magnetomechanical stimulation. (Science Translational Medicine)

Retrospective Study: Evidence for Spinal Cord Stimulation to Relieve Low Back Pain from Degenerative Disk Disease

July 6, 2018 - An article summarizes a retrospective study by International Neuromodulation Society member Stephen Pyles, MD, and colleagues. In it, 45 patients with horizontal low back pain and lumbar degenerative disk disease were followed for one year after receiving spinal cord stimulator implants. A significant fraction of the patients experienced pain reduction. The researchers reported that stimulation at T7 worked well 87% of the time, and leads were moved up or down if that location was ineffective. For the first 24 hours, the patients received conventional stimulation that evoked paresthesias. For the second 24 hours, they received subthreshold stimulation. On the third day, they were allowed to select which stimulation program they preferred. (Pain Medicine News)

Study: Brain Stimulation Study Showed Change in Aggressive Intent

July 2, 2018 - Researchers published a double-blind, randomized controlled study in the Journal of Neuroscience in which volunteers who received active transcranial direct current stimulation to the dorsolateral prefrontal cortex were less likely to express aggressive intent than volunteers who received a sham treatment. (Washington Post)

Study: Early Deep Brain Stimulation May Slow Progression of Tremor in Parkinson's Disease

June 30, 2018 - Deep brain stimulation (DBS) may slow development of tremor, according to a post-hoc analysis in a study that compared optimal medical therapy alone with optimal medical therapy plus DBS in patients with early Parkinson's disease. The study began at Vanderbilt University in 2006 with a total of 28 patients. The analysis appeared in early view in the journal Neurology. Following these findings, starting in 2019, Vanderbilt will lead an FDA-approved, Phase III multicenter study that will enroll up to 280 people with very early Parkinson's disease. (News-Medical.net)

Japan Approves Implantable Device for Obstructive Sleep Apnea

June 29, 2018 - Inspire Medical Systems has won approval in Japan for its implantable neurostimulator to treat moderate to severe obstructive sleep apnea. The company said it plans to pursue reimbursement and launch the device in Japan in the second half of next year. (Mass Device)

Review Considers Investigations of Transcranial Direct Current Stimulation to Treat Chronic Pain

June 26, 2018 - A literature review summarizes evidence of the effects of transcranial direct current stimulation for treating chronic pain. The authors consider stimulation parameters, combination therapies, and selection of research participants. (The Journal of ECT)

Study: Spinal Cord Stimulator Trial May Be Unnecessary for Certain Complex Regional Pain Syndrome Patients

August 2018 - Clinicians in Brazil published data about 33 spinal cord stimulation recipients who had unequivocal diagnoses of complex regional pain syndrome type 1. They say the data from this group, who were among 160 patients implanted with spinal cord stimulators from 2011 - mid 2017, suggest that a trial phase may be unnecessary in this subgroup of patients. They add that the patients received a constant current implant and that intraoperative testing was used to determine the precise location of the implant. (Clinical Neurology and Neurosurgery)

10-Year Followup Found Lower Risk of Psychosis or Falls in Parkinson's Disease Patients Who Received Deep Brain Stimulation

June 21, 2018 - Deep brain stimulation (DBS) to the subthalamic nucleus was associated with fewer falls and less psychosis during 10 years of followup, compared to controls, according to results presented at the Congress of the European Academy of Neurology 2018 meeting. The results were based on 53 patients who received DBS and 52 patients who did not. Over time, 25% of the DBS patients and 52% of patients in the control group developed hallucinations or delusions. In both groups, nearly three-fourths had recurrent falls, but the DBS group had fewer falls overall. (Medscape)

Television Segment Portrays Dorsal Root Ganglion Stimulation for Chronic Extremity Pain

June 20, 2018 - A television segment features a woman with chronic foot pain who received a dorsal root ganglion stimulator through the UK National Health Service. In the segment, she is shown just before and during the procedure, and then walking unaided soon after recovery. (BBC)

Newspaper Reports First Colorectal Patients to Receive Sacral Nerve Stimulators in Dubai

June 21, 2018 - Two patients in Dubai received sacral nerve stimulation systems for colorectal problems. An article says their hospital is the first in the emirate to perform these implants for fecal incontinence and chronic constipation. (Gulf Today)

Scholarship Winner Works on Flexible Spinal Cord Stimulation Arrays

June 21, 2018 - An undergraduate university student in Texas who is working on neuromodulation projects was featured in an article about scholarship recipients. One project is for a spinal cord stimulator array that is stiff at room temperature, but softens and becomes more flexible after implantation. She will spend the summer at the Swiss Federal Institute of Technology Lausanne on a project to to augment recovery after spinal cord injury. (University of Texas at Dallas)

Engineers Use Transcutaneous Nerve Stimulation to Add Sensations to Prosthetic Hand

June 20, 2018 - An article in Science Robotics describes how a research team added a sense of touch to a prosthetic hand by electrically stimulating peripheral nerves in a volunteer amputee's arm in a pattern that replicated behavior of mechanoreceptors and nociceptors, in response to tactile qualities detected by the surface of the prosthesis, such as sharp edges. The volunteer said the sensations felt like they were coming from a phantom hand. (Gizmodo)

Doctoral Student Develops New Targeting System for Deep Brain Stimulation

June 20, 2018 - A PhD candidate in the Netherlands has created an apparatus for targeting deep brain stimulation that is anticipated to be faster to use, and to aid surgical accuracy. (Medical Xpress)

Researchers: Brain-Computer Interface Aided Motor Recovery from Stroke

June 20, 2018 - Researchers in Switzerland report in Nature Communications that stroke survivors with partial arm paralysis made more progress when functional electrical stimulation of their affected hand was timed to coincide with their intent to move as detected by a brain-computer interface (BCI), compared to a control group that received hand-muscle stimulation that was not timed to coincide with the detectable brain activity. Overall 27 patients participated. Significant improvement was seen in the group that had BCI-directed stimulation after 10 hour-long sessions. The authors report that in the BCI-directed group, EEGs showed increased connections in the motor cortex of the damaged brain hemisphere, noting that at a six-month followup, the functional improvement continued. (EurekAlert)

Researchers: Brain-Computer Interface Aided Motor Recovery from Stroke

June 20, 2018 - Researchers in Switzerland report in Nature Communications that stroke survivors with partial arm paralysis made more progress when functional electrical stimulation of their affected hand was timed to coincide with their intent to move as detected by a brain-computer interface (BCI), compared to a control group that received hand-muscle stimulation that was not timed to coincide with the detectable brain activity. Overall 27 patients participated. Significant improvement was seen in the group that had BCI-directed stimulation after 10 hour-long sessions. The authors report that in the BCI-directed group, EEGs showed increased connections in the motor cortex of the damaged brain hemisphere, noting that at a six-month followup, the functional improvement continued. (EurekAlert)

Study: Deep Brain Stimulation to the Fornix Appears to Slow Progression of Mild Alzheimer's Disease in Older Patients

June 19, 2018 - In a Phase II clinical trial of deep brain stimulation to the fornix for mild Alzheimer's disease, an analysis shows that patients over age 65 benefited the most by appearing to have a slower progression of the disease. In the study, 42 patients were implanted, and after a 12-month randomization period in which half the patients did not receive simulation, all the patients had their electrodes turned on and were followed for another 12 months. (Medical Xpress)

Findings Suggest Non-Invasive Brain Stimulation May Help Improve Disorders of Consciousness

June 18, 2018 - Disorders of consciousness might be improved by non-invasive brain stimulation, suggests an expert who spoke at the 4th Congress of the European Academy of Neurology in Lisbon. In a study, his research group found the extent of impairment fluctuated when they scored coma ratings four times a day. They saw improvements after a session of transcranial direct current stimulation, with improvement lasting up to a week after five consecutive daily stimulation sessions. (News-Medical.net)

Company Updates Anticipated FDA Submission Timeframe

June 18, 2018 - Helius Medical Technologies, Inc. now expects to submit its request to the FDA for de novo classification and 510(k) clearance in the third quarter of 2018. The company met with the FDA in April through the agency's pre-submission program and plans to meet again in July. The company's investigational device, the Portable Neuromodulation Stimulator, provides non-invasive cranial nerve stimulation, through use of a component that rests on the tongue, with physical and cognitive therapy to regain lost neurological function. (Globe Newswire)

Non-Invasive Brain Stimulation Study Aims to Improve Stroke Recovery

June 18, 2018 - A research team at Murdoch University are looking for 10 stroke survivors for a study of non-invasive brain stimulation to help improve balance, reaching and grasping. (Melville Times)

UK Boy with Epilepsy Receives a Newly Approved Vagus Nerve Stimulation System that Detects Seizure Onset

June 17, 2018 - A 9-year-old boy in England became the first patient in Europe to receive a vagus nerve stimulation system that detects the onset of epileptic seizures. The National Health Service provided the device after CE mark was granted in April. The patient was born with a rare brain malformation, lissencephaly, which causes his seizures and made him ineligible for brain surgery. (Daily Mail)

Maker of a Transcranial Magnetic Stimulation Device Prices Its Initial Public Offering

June 15, 2018 - Neuronetics announced terms of its initial public offering. The company, which intends to expand commercialization of its transcranial magnetic stimulation device for treating depression, seeks to raise $75 million by offering 5 million shares at a price range of $14 to $16. (Renaissance Capital)

Engineers Work on Potential Ultrasound Neurostimulation Device

June 15, 2018 - Researchers at Stanford University are working on an implanted stimulator that would be powered and programmed with ultrasound. The concept consists of a body-worn ultrasound transmitter to power a deeply implanted piezoelectric receiver, which converts ultrasound energy to electricity. The design has a capacitor for storing electricity, two stimulating electrodes, an LED, and custom circuitry. The implant would not only be powered by converting ultrasound energy, but also programmable through amplitude modulation of the ultrasound waveform. (PC Magazine)

Tibial Nerve Stimulation System Study Design for Patients with Overactive Bladder is Approved by the FDA

June 14, 2018 - The FDA has approved the proposed study design for BlueWind Medical's battery-less, miniature, implantable tibial nerve neuromodulation system intended for the management of overactive bladder (OAB). The OAB neurostimulation study, OASIS, will seek to enroll 250 patients at up to 25 medical centers in the UK, the Netherlands, Belguim, and Germany. The design calls for assessing the number of responders at 6 months, and following patients for 12 months to assess safety and durability of the potential effect. The device received CE mark for OAB in 2016. (MD Magazine)

Patient Describes Participating in Vagus Nerve Stimulation Study for Crohn's Disease

June 14, 2018 - An article about SetPoint Medical's small clinical trial of vagus nerve stimulation for Crohn's disease features an interview with a patient who has seen a reduction in symptoms. The patient from New Jersey spoke at a bioelectronic medicine conference in Stockholm, hosted by the Feinstein Institute for Medical Research and the Karolinska Institutet. Preliminary results of the 16-person study were presented in a poster at the Digestive Disease Week meeting in Washington, D.C. earlier in the week. (IEEE Spectrum)

Article Describes Percutaneous Direct Current Treatment of Injuries and Severe Cluster Headache

June 14, 2018 - A case series of cluster headache, a torn quadriceps muscle, and stained ankle with ruptured ligament were reported in a journal article about translating the electrical signals that stimulate wound healing into a direct current stimulation applied to percutaneous metal probes, which the authors claim provided an effective treatment. (Medical Devices: Evidence and Research)

Wait Times Questioned for Deep Brain Stimulation in British Columbia

June 13, 2018 - An article about a Parkinson's disease patient in the Vancouver area who may have a roughly two-year wait for deep brain stimulation (DBS) surgery describes her efforts to encourage the provincial government to fund an additional operating room to cut waiting times. While she fears missing her therapeutic window, she would like to see access improved for all the patients in her province. International Neuromodulation Society member Christopher Honey, MD, PhD comments in the article that he has trained another neurosurgeon but they need a second operating room so more procedures can be scheduled. The article says that while the average for DBS surgery is one surgeon per two million people, in their province of British Columbia, the rate is one surgeon per 4.5 million people. The journalist has also written a column encouraging others to join the letter-writing campaign. (Abbotsford News)

Company's Physician Programmer Receives FDA Approval

June 13, 2018 - Medtronic said it has won FDA approval for its deep brain stimulation programmer and associated software for its Activa rechargeable system. (Mass Device)

FDA Clears Neurostimulation Device for Reduction in Opioid Withdrawal Symptoms

June 12, 2018 - The FDA has provided clearance for an auricular neurostimulation device, Drug Relief, by DyAnsys Inc. for treatment of opioid withdrawal symptoms. The symptoms include anxiety, agitation, depression, nausea, and opiate cravings. The company said the device is used for 120 hours and may begin reducing symptoms within an hour. It is available by prescription for patients undergoing opioid detoxification. (MD Magazine)

Column Envisions Continued Development of Closed-Loop Neurostimulation to Treat Additional Conditions

June 11, 2018 - A guest column from research leaders at Battelle describes required elements of closed-loop neurostimulation systems, and acknowledges existing commercial closed-loop devices by Saluda and Neuropace. The authors anticipate that "as more is learned about how the nervous system regulates body systems, the potential applications for bioelectronic treatments will continue to grow." They said additional chronic conditions might be addressed by closed-loop systems through identifying biomarkers; further development of biocompatible materials; and creation of better algorithms. (Medical Device Online)

Brain-Machine Interface Startup Receives $7 Million in Seed Funding

June 11, 2018 - A California startup, Paradromics, has received $7 million in seed funding to develop brain-machine interface technology. The company wants to initially develop a way for people with locked-in syndrome to communicate. Earlier, it received $18 million from the U.S.Defense Advanced Research Projects Agency. The company is working on sensors for the cerebral cortex. (Fierce Biotech)

Neurostimulation Company Announces Product Launch in Canada

June 11, 2018 - Bioness said its StimRouter neuromodulation system has been implanted in the first procedures in Canada, at Toronto’s Women’s College Hospital.The minimally invasive peripheral nerve stimulation device is designed to provide adjunctive treatment for chronic pain. (Mass Device)

Article Describes Growing Interest in India in Neuromodulation Treatments for Psychiatric Conditions

June 10, 2018 - International Neuromodulation Society member Paresh Doshi, MBBS, MS (General Surgery), MCh (Neurosurgery), was quoted in an article about access to neuromodulation for depression in India. According to the article, Dr. Doshi said the Mental Health Act of 2017 allows psychiatric surgery to be performed if overseen by an ethics committee or hospital review board. At his hospital in Mumbai, there have been 14 deep brain stimulation surgeries on patients for obsessive compulsive disorder and depression, including three from Australia and two from the U.S. There also are plans to offer repetitive transcranial magnetic stimulation and vagus nerve stimulation for depression. (Daily News and Analysis India)

Television Segment Presents Neurostimulation as an Alternative to Reliance on Pain Medication

June 6, 2018 - A news segment about a woman who was confined to her recliner and depended on a walker for a decade after her car accident says she learned about spinal cord stimulation from a Facebook group for chronic pain sufferers. Since receiving her device, she has been able to reduce her pain medications and become more active. Her physician pointed out the drug-free advantages of neurostimulation. (WSBT)

Overview of Pain Therapy Development Acknowledges Growth in Neuromodulation

June 6, 2018 - A column about the evolution of pain therapies mentions the rise in opioid-based treatments as well as two decades of growth in neuromodulation therapies as neurostimulation devices have become more advanced. (Neurology Reviews)

Non-Invasive Brain Stimulation Device Company Sets Terms for Initial Public Offering

June 5, 2018 - ElectroCore, which makes a non-invasive device to treat migraine, announced terms for its initial public offering. The company seeks to raise $65 million, and will offer 4.3 million shares in a price range of $14 to $16. (Nasdaq)

Company Wins Patent for Neurostimulation with Potential Promise in Diabetes

June 5, 2018 - ReShape Lifesciences announced it has been granted a U.S. patent for devices and methods that provide combined blocking and stimulation of the vagus and celiac nerve branches that innervate the pancreas and liver. The company's product portfolio encompasses treatment of obesity and metabolic disease. The newly patented innovation was shown in a rat model of diabetes to provide better glycemic control, an important factor in diabetes. (Vision)

Company's Deep Brain Stimulation System Now Available in South Korea

June 5, 2018 - Boston Scientific Corporation announced it is now providing its Vercise deep brain stimulation system in South Korea for patients with movement disorder. The system gained reimbursement there beginning June 1. (Korea Biomedical Review)

Auditory Brainstem Implants Now Available in New Zealand

June 5, 2018 - Six patients, aged 4 to 57 years, received the first auditory brainstem implants available in New Zealand, over the course of five days. The implant provides some sense of hearing for people whose auditory nerve is missing or damaged. (Scoop Sci-Tech)

Researchers Envision Prototype Wireless Implant Might Provide Brain Stimulation

June 4, 2018 - Researchers from MIT and Brigham and Women's Hospital in Boston plan to present their preclinical work at a meeting in August on prototype miniaturized implants that can receive power and communicate wirelessly, potentially being able to provide brain stimulation. (UPI)

A Medical Device Registry is Being Launched by the U.S. Department of Veterans Affairs

June 1, 2018 - The U.S. Department of Veterans Affairs hosted a daylong summit on the launch of a registry among its insured populace to track medical implant devices, which might include cardiac pacemakers, joint replacements, and neurosurgical implants. (U.S. Dept. of Veterans Affairs)

Device Maker Announces Launch of Next-Generation Closed-Loop Neurostimulator for Epilepsy

June 1, 2018 - NeuroPace, Inc. announced the first patient with medication-resistant epilepsy has been implanted with its Next Gen RNS System, which has been designed with a longer battery life and more memory. The company's neurostimulation device monitors brain activity for patterns that suggest a seizure onset, and applies stimulation before seizures occur. (Business Wire)

Column Discusses Potential for Neurostimulation and Other Technologies to Address the Opioid Epidemic

June 1, 2018 - A column about a recent FDA call for medical technology to address the opioid epidemic points out that spinal cord and nerve stimulation systems are pain management solutions that could curb opioid use. The article notes that the FDA is "open to developers of currently marketed devices who are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain." In addition, the article notes that a nerve stimulator by the company Innovative Health Solutions received FDA approval last year to be used for opioid withdrawal. (MD+DI)

Clinicians Publish Article About Introducing a Sense of Position to a Prosthetic Limb

May 30, 2018 - Researchers published an article in Science Translational Medicine about implantation of a below-the-knee prosthetic leg  that was designed to give a sense of leg position (proprioception) by interfacing with the peripheral nervous system. (MIT News)

Non-Invasive Brain-Stimulation Device Maker Files for $86 Million Initial Public Offering

June 1, 2018 - Neuronetics, Inc. filed for an initial public offering valued at more than $86 million. The company, which plans to trade on the NASDAQ exchange, said it intends to expand commercialization of its transcranial magnetic stimulation device for treating depression. (Mass Device)

Patient Receives Deep Brain Stimulation for Obsessive Compulsive Disorder in Upstate New York

May 31, 2018 - International Neuromodulation Society member Julie Pilitsis, MD, PhD was interviewed in a news story about a young woman who received deep brain stimulation (DBS) to address medication-resistant symptoms of obsessive compulsive disorder. In the segment, Dr. Pilitsis explained the general theory is that DBS creates a "white noise" that allows the brain to fire normally. The television segment said the Albany facility is the only center between New York City and Boston that offers DBS. (WNYT)

Comment Period Opens About Vagus Nerve Stimulation for Treatment-Resistant Depression

May 30, 2018 - The U.S. Centers for Medicare & Medicaid Services has opened a 30-day comment period after it was formally requested by LivaNova PLC to reconsider its decade-old national non-coverage determination for the company's vagus nerve stimulation system for treatment-resistant depression. The company said significant evidence of the treatment's effectiveness in this indication has emerged over that last decade, and that coverage would aid patients and physicians. (Business Wire)

Collaborators Receive $9 Million, Four-Year Grant to Study Infrared Neuromodulation

May 30, 2018 - The National Institutes of Health is granting researchers at three universities $9 million over four years to study infrared neuromodulation for therapeutic purposes. The research is being led by Case Western Reserve University School of Medicine. A blog post there describes the interest in potentially treating conditions that may involve the autonomic nervous system, such as cardiac arrhythmias, high and low blood pressure, asthma, sleep apnea, and severe diarrhea. Collaborating institutions are Vanderbilt University and the University of Pittsburgh. (Crain's Cleveland Business)

Feasibility Study Monitors Motor Cortex Activity to Adjust Deep Brain Stimulation

May 29, 2018 - A feasibility study demonstrated using a recording electrode on the motor cortex to adjust deep brain stimulation based on the apparent presence of dyskinesias. The study in two patients showed no differences in improvement in movement between traditional constant stimulation or the adaptive stimulation. However, the researchers say the adaptive approach saved about 40% of the battery power. (NIH)

Post-Traumatic Stress Disorder Research Investigates Brain Circuits, Non-Invasive Stimulation

May 29, 2018 - An article describes research into understanding different brain circuits involved in post-traumatic stress disorder (PTSD) and using repetitive transcranial magnetic stimulation, or other methods, as part of the treatment. One researcher has identified four distinct patterns of brain activity after analyzing scans of 106 people with PTSD. Another has designed a clinical trial to offer veterans exposure therapy using virtual reality, combined with brain stimulation using transcranial direct current brain stimulation. (The Daily Beast)

Geneva Hospital Recruits Neuromodulation Practitioners to Staff a New Pain Clinic

May 30, 2018 - An article (in French) describes how International Neuromodulation Society members Blaise Rutschmann, MD and Christophe Perruchoud, MD were recruited to open a new pain clinic in Geneva at l’Hôpital de La Tour. (Tribune de Genève)

Article Summarizes Research Interest in Transcranial Direct Current Stimulation

May 29, 2018 - An article describes potential clinical applications of transcranial direct current stimulation in various mental and cognitive disorders, explaining that interest stems from its ease of use and apparently few adverse effects, although clinical utility has not been established and long-term effects are unknown. (News-Medical.net)

Article Features Young Woman Who Received a Vagus Nerve Stimulator Implant for Epilepsy

May 28, 2018 - A news feature about a 21-year-old woman diagnosed with epilepsy 10 years ago presents vagus nerve stimulation, describing the therapeutic device she had implanted last year by providers with the U.K. National Health Service. (Daily Mail)

Findings from One Deep Brain Stimulation Target Reveal a Role for Dopamine in Insulin Sensitivity

May 28, 2018 - A report in Science Translational Medicine details research into the effects of deep brain stimulation (DBS) of the nucleus accumbens on insulin sensitivity. The study followed the observation that a man with a DBS system for obsessive compulsive disorder (OCD) noticed his need for insulin to control his Type 2 diabetes had decreased 80%. The researchers looked at the effects of brain stimulation on insulin sensitivity in 12 patients who had OCD. They also examined how drugs to reduce dopamine levels in healthy people affected insulin sensitivity. Finally, they used optogenetics in mice and saw that boosting dopamine production improved glucose tolerance. (Greely Tribune)

Neurologists and Physicists Publish a Neuroscience Paper that Suggests Slowing the Rate of Transcranial Magnetic Stimulation

May 27, 2018 - Researchers who analyzed clinical studies and stimulation of cultured cortical neurons say the maximal firing rate of neurons may be lower than presumed, and suggest that a slower rate of repetitive transcranial magnetic stimulation may be more effective. (Times of Israel)

Neurostimulator Study Showed Improvements in Pain, Disability, and Quality-of-Life Scores Over Baseline

May 25, 2018 - International Neuromodulation Society member Vivek Mehta, FRCA, MD, FFPMRCA, presented results of a single-arm prospective safety and efficacy trial of an implantable neurostimulation system to address disabling chronic refectory low back pain, ReActive8-A, during the World Congress of the World Institute of Pain in Ireland in May. To restore stability of the lower back, the device stimulates muscle contractions of the lumbar multifidus. There were 53 enrollees in the trial, who were followed for up to one year. Pain scores improved by 33%±6% at one year, and 94% of patients had a clinically significant improvement in pain, with improvements in disability and quality of life at 86% and 87% respectively. (NeuroNews)

Company Plans Initial Public Offering

May 21, 2018 - ElectroCore filed Monday for a $75 million initial public offering on the Nasdaq, planning to trade under the symbol ECOR. Pricing details were not disclosed. (Nasdaq)

Neuromodulation Discussed at Urology Meeting

May 21, 2018 - A number of presentations at the annual meeting of the American Urological Association concerned neuromodulation. A presenter who discussed third-line therapies for overactive bladder said she considers percutaneous tibial nerve stimulation (PTNS) between second- and third-line treatment, or "level 2.5". She said it is easy to use, minimally invasive, has minimal adverse events, and has level 1 evidence. Meanwhile, she added that advantages of sacral nerve stimulation as a third-line therapy include its efficacy in also treating urinary retention and fecal incontinence.

Another presenter discussed an observational pilot study of 11 patients with sacral nerve stimulators for urinary urge incontinence who did not have their devices explanted before receiving 1.5T MRIs of the lumbar or pelvic area. The authors noted no more than minimal discomfort, and no change in therapeutic efficacy.

Finally, data were presented from 116 drug-naive patients who underwent 12 sessions with a percutaneous tibial neuromodulation system for overactive bladder. The RESET study was a multi-center, single arm, prospective study. (UroToday.com)

Hospital in India Focuses on Chronic Pain Management

May 21, 2018 - A press release announces the availability of neuromodulation and other interventional pain procedures at a 50-bed hospital dedicated to the management of chronic pain in Calcutta, India. The announcement says the facility also provides training for specialists and pain management fellowships. (PR.com)

Study: Deep Transcranial Magnetic Stimulation Increased Beta-Endorphins in Obese Participants

May 20, 2018 - A controlled study of 40 people with obesity found that a 30-minute session of deep transcranial magnetic stimulation at high frequency led to an increase in beta-endorphins in the bloodstream of obese participants. Beta-endorphins are potentially associated with heightened feelings of reward after eating. The study, which examined both low- and high-frequency stimulation, was presented at the European Society of Endocrinology annual meeting in Barcelona. (EurekAlert)

Device Company Announces CE Mark Approval for Wirelessly Powered Sacral Nerve Stimulator

May 17, 2018 - StimGuard LLC announced it received CE Mark approval of its wirelessly powered sacral nerve stimulation system to treat intractable symptoms of overactive bladder. The company plans to launch sales of the device in the European Union in the summer. (Mass Device)

Data Presented Concerning Non-invasive Vagus Nerve Stimulation to Treat Migraine Attacks

May 17, 2018 - International Neuromodulation Society member Peter Staats, MD, described findings presented at the American Academy of Neurology annual meeting about treatment of migraine and episodic cluster headache through noninvasive vagus nerve stimulation, using an FDA-cleared device by electroCore, where he is chief medical officer. The results of a randomized, double-blind trial in 243 migraine patients showed the gammaCore device outperformed sham in treating a migraine attack at 30 and 60 minutes. The hand-held device was also shown to be better than sham at 120 minutes in a post hoc repeated-measures analysis. (Healio)

Television Segment Features Neuromodulation as an Alternative to Opioids

May 17, 2018 - International Neuromodulation Society member Joshua Prager, MD, was interviewed along with a pain patient about how neuromodulation can be a "non-addictive" approach to managing some pain conditions. (Fox 2 Now)

Researchers Create Prototype Non-invasive Brain Stimulation Headgear for Home Use

May 15, 2018 -  Researchers report they have created a prototype headgear for transcranial direct current stimulation in home or clinical settings that can be postponed over the motor cortex and opposite-side supraorbital region without requiring measurements. In a clinic, positioning typically involves taking recordings using electroencephalography (EEG). (Neuromodulation: Technology at the Neural Interface)

Results Presented in Randomized, Controlled Clinical Trial of Deep Brain Stimulation System

May 15, 2018 - According to results presented at the American Association of Neurological Surgeons' annual meeting, the Boston Scientific Corporation's Vercise deep brain stimulation (DBS) system, approved by the U.S. FDA in December 2017, met its primary and many secondary endpoints in the INTREPID trial. The trial of the multiple-source, constant-current system in 160 patients with Parkinson's disease was blinded and sham-controlled during the 12-week randomization period. The primary outcome was the difference between groups in the mean number of waking hours per day with good symptom control in the absence of troublesome dyskinesias or medication increases. The mean difference in these "on" periods was 3.03 ± 4.5 hours for active treatment compared to sham. (Medscape)

Study: Non-Invasive Brain Stimulation Lowered Reactivity to Addiction Cues

May 15, 2018 - Researchers report in Biological Psychiatry they were able to reduce reactivity to addiction cues in study subjects who had cocaine-use disorder or alcohol-use disorder. The reactivity was seen as elevated brain activity in response to cues, such as seeing an image of a liquor bottle. Such responses predict relapse in addiction. In this study, the subjects did not report reduced cravings. Forty-nine subjects participated in the sham-controlled study, which involved a single session of continuous theta burst stimulation to the left ventromedial prefrontal cortex. (R&D Magazine)

Researchers Analyze Non-Invasive Brain Stimulation Effects on Fine Motor Control

May 11, 2018 - In a meta-analysis of published studies about non-invasive brain stimulation on fine motor control, researchers found that transcranial direct current stimulation and transcranial magnetic stimulation may have beneficial effects on fine motor movement in healthy participants and patients undergoing rehabilitation after stroke. (EurekAlert)

Company Begins Clinical Evaluation of Its Noninvasive Brain Stimulation Device for Migraine Pain

May 9, 2018 - Israel-based Neurolief's non-invasive brain stimulation device has begun clinical trials as a potential method to reduce migraine pain. The device provides transcutaneous electrical stimulation to the occipital and supraorbital nerves. The company expects a study in 56 patients to be completed this year. (Globes)

Meta-Analysis: Transcranial Magnetic Stimulation Improved Walking Speed After Stroke

May 9, 2018 - An international team of authors published an analysis of six studies of repetitive transcranial magnetic stimulation (rTMS) following stroke. The studies with 139 patients total showed there was significant improvement in walking speed in patients who received rTMS, especially when stimulation was applied to the same side as the stroke. (Medical Xpress)

Clinicians Use Deep Brain Stimulation Electrodes to Detect a Potential Therapeutic Biomarker

May 2018 - Clinical researchers in Australia studied neural activity in response to deep brain stimulation in 19 patients who have movement disorder. They identified a large‐amplitude resonant neural response to stimulation of the dorsal region of the subthalamic nucleus, a clinically optimal stimulation target for Parkinson's disease. The study authors say the response might serve as a biomarker to facilitate improved targeting of therapeutic stimulation. (Annals of Neurology)

FDA Clears Company's Transcranial Magnetic Stimulation Component

May 6, 2018 - BrainsWay Ltd. announced it has received FDA clearance for a stimulator to be integrated into its deep transcranial magnetic stimulation system for treatment of major depressive disorder. (Globe Newswire)

Company Raises $108 Million in Initial Public Offering

May 3, 2018 - Inspire Medical Systems raised $108 million from an initial public offering of 6.75 million shares, priced at the high end of its range at $16 per share. Trading opened on the New York Stock Exchange Thursday at $24.49 per share. Initially the company anticipated making $75 million from a public offering of 5 million shares. Spun out from Medtronic in 2007, the company makes an implantable neurostimulator for obstructive sleep apnea. It said proceeds would largely go to sales and marketing in the U.S. and Europe, as well as further research and development. (Twin Cities Business)

Study of Transcranial Magnetic Stimulation in Depression Highlights Potential Role of Right Frontal Lobe in Suicidal Ideation

May 3, 2018 - A study in the Journal of Clinical Psychiatry showed that bilateral transcranial magnetic stimulation reduced suicidal thinking in 40 percent of study participants. The study pooled published data from two prospective studies. At the start, 156 participants with depression experienced suicidal thoughts. All participants were randomized to receive bilateral stimulation, or sham stimulation, or stimulation only to the left frontal lobe. Based on the findings, the authors plan to study stimulation to the right frontal lobe, which earlier research suggests may be linked to impulsivity and difficulty with emotional regulation in people with depression and suicidal ideation. The authors added that decreases in suicidal thinking were not strongly linked to reduction in severity of depression. (News-Medical.net)

Neurosurgeons Report a Case of a Deep Brain Stimulator Turning Off During a Lightning Storm, and Offer Recharging Advice

May 1, 2018 - An article in the Journal of Neurosurgery reports that a woman in Slovenia noticed her deep brain stimulation system was turned off an hour after appliances in her apartment were ruined during a lightning storm. The physicians who treat the woman for dystonia recommend that patients use a surge protector to recharge their recharger, then then unplug the recharger before using it to recharge the implantable pulse generator They noted that she was not recharging her system at the time, and that it remained undamaged, apparently having been switched off by an integrated safety system that detects interference from strong electromagnetic fields. (New Scientist)

Clinicians to Assess Vagus Nerve Stimulation During Stroke Rehabilitation

May 2, 2018 - International Neuromodulation Society member Marcia Bockbrader, MD, PhD was interviewed in an article about a clinical trial that will evaluate implanted vagus nerve stimulation during rehabilitation from stroke. The trial will include a control arm of patients who do not receive an implanted device. The study follows an earlier pilot study that showed about 85% of stroke patients who received the stimulation during physical rehabilitation benefited. (Medical Xpress)

Study Results Presented About External Trigeminal Nerve Stimulation to Halt Migraine Attacks

May 1, 2018 - At the 18th Congress of the International Headache Society, results of a multi-center, double-blind, randomized, sham-controlled clinical trial were presented that demonstrated that external trigeminal nerve stimulation -- already approved for prevention of migraines -- was effective in treating acute migraine episodes. (Newswire.net)

Company's Deep Brain Stimulator Receives Approval in U.S. for Epilepsy

May 1, 2018 - The U.S. FDA has granted premarket approval for adjunctive use of Medtronic's deep brain stimulation therapy for adults with medically refractory, partial-onset epilepsy. (MD Magazine)

FDA Clears Non-Invasive Stimulator for Essential Tremor

April 26, 2018 - A wrist-worn, non-invasive stimulator for transient relief of hand tremors in essential tremor has received clearance from the U.S. FDA. The device by Cala Health delivers patterned electrical stimulation through the skin. (Cala Health)

Presentation Suggests Unilateral Deep Brain Stimulation May Suffice for Axial Symptoms of Essential Tremor

April 27, 2018 - In a subsidy of 119 patients with essential tremor, 80 of whom had unilateral deep brain stimulation (DBS), the other who had had bilateral, the group with unilateral DBS was shown to have more than 50% improvement in axial symptoms up to 12 months. The study, presented at the American Academy of Neurology annual meeting, concludes that unilateral DBS may allow patients with axial symptoms avoid some side effects of bilateral DBS to the ventral intermediate nucleus. (Medscape)

Introductory Video Attempts to Demystify Deep Brain Stimulation Technology

April 27, 2018 - Abbott has produced an overview video showing deep brain stimulation (DBS) devices. The video calls DBS "a mind-blowing technology that's changing the future of healthcare." (Diversity Inc.)

Study Intended to Raise Awareness of Spinal Cord Stimulation as an Option

April 26, 2018 - International Neuromodulation Society member Tim Lamer, MD, presented a poster at the American Academy of Pain Medicine annual meeting that summarizes a systemic review of 30 years of randomized controlled trials of spinal cord stimulation (SCS). Among its findings were that newer stimulation modes led to increased odds of pain relief, and that SCS significantly reduced pain compared to medical therapy. (Vision)

Market Study Indicates Shifts in Market Shares for Neuromodulation Device Makers

April 23, 2018 - The Neurotech Reports newsletter predicts that the global market for neurotechnology products will be $8.4 billion in 2018 and grow to $13.3 billion by 2022, a 12-percent compound annual growth rate. It also traces changing market share among the main providers of spinal cord stimulation and deep brain stimulation devices. (Globe Newswire)

Comparative Study: Short Brain Stimulation Sessions Effective in Depression

April 26, 2018 - A comparative study of 414 patients with treatment-resistant depression, published in The Lancet, found that three minutes of repetitive transcranial magnetic stimulation (rTMS) with intermittent theta burst stimulation (iTBS) was as effective as the standard treatment of high frequency (10 Hz) stimulation for 37.5 minutes. The authors reported that 49 percent of patients who received iTBS had significant reduction in symptoms, with 32% reporting remission, compared to a remission rate of 27% in the group that received standard high-frequency stimulation. The study was carried out in Canada, where public health authorities in the provinces of Quebec and Saskatchewan will cover the cost of treatment. Use of rTMS was approved for treating depression by Health Canada in 2002, and by the U.S. FDA in 2008. (EurekAlert)

Control Module Helps Retain Sensation in Prosthetic Arms

April 26, 2018 - Researchers in Illinois demonstrated a way of processing nerve stimulation when providing a sense of touch to a prosthetic limb so that the sensation is durable under real-world usage conditions, for instance, when the electrodes begin to peel off or sweat builds up. The lead author of a published report about the sensory control module has begun a company that develops bionic arms meant to be affordable in developing parts of the world. (Science Daily)

Researchers Report a Novel Approach to Transcranial Magnetic Stimulation for Complex Regional Pain Syndrome

April 25, 2018 - An open-label study published in Neuromodulation: Technology at the Neural Interface of 21 patients who had upper and lower extremity pain from complex regional syndrome showed promise from a novel form of repetitive transcranial magnetic stimulation. The patients received intermittent theta-burst stimulation over the motor cortex corresponding to their pain location. This was followed by 10 Hz high-frequency stimulation using a deep targeting coil. The patients received either a single session or five consecutive sessions. The first group had 60% responders at week 1, and the second group had 58% and 50% responders at weeks 1 and 2, respectively. (Clinical Pain Advisor)

Non-Invasive Spine Stimulation Aided Functional Rehabilitation of Patients with Spinal Cord Injury

April 25, 2018 - Researchers report that eight sessions of transcutaneous spinal cord stimulation combined with neurorehabilitation training allowed six people with spinal cord injuries to recover some functional use of their hands and fingers, allowing them to perform more tasks independently. Also, some physiologic functions, such as blood pressure, improved, as did the ability to sit upright without support. (UCLA)

U.K. Publication Features Phantom Limb Syndrome and Neuromodulation Treatments

April 25, 2018 - International Neuromodulation Society member Nigel Kellow, MBBS, was interviewed in a detailed overview of phantom limb syndrome and treatments, including spinal cord stimulation and deep brain stimulation. (BT Insider)

Analysis Examines Outcomes of Parkinson's Patients with Depression Who Received Deep Brain Stimulation

April 25, 2018 - An analysis of 1,037 patients with Parkinson's disease admitted to the hospital from 2010 - 2014 with an additional diagnosis of major depressive disorder showed that the 70 who underwent deep brain stimulation (DBS), despite increased hospitalization costs, had shorter hospitalizations and lower rates of transfer to acute-care hospitals or skilled nursing facilities. The study was presented at the annual meeting of the American Academy of Neurology. Based on the positive outcomes, the investigators recommend consideration of such patients for DBS in a multidisciplinary team setting that includes psychiatric evaluation and input. (Neurology Advisor)

One-Year Results Presented for U.S. Multi-Center Study of Deep Brain Stimulation in Parkinson's Disease

April 24, 2018 - Boston Scientific Corp. announced one-year results from its INTREPID study of deep brain stimulation for Parkinson's disease, a prospective, double-blind, randomized, sham-controlled study. There were 292 patients enrolled at 23 U.S. centers. The data showed a 49.2% improvement in motor symptoms and longer "on" time and improved quality of life. The results were presented at the American Academy of Neurology annual meeting. (Markets Insider)

Study: Chronic Pain Symptoms, Opioid Use, Decreased at One Year

April 24, 2018 - International Neuromodulation Society member Peter Staats, MD, commented on a subanalysis of the SUNBURST burst-mode spinal cord stimulation study presented at the January 2018 annual meeting of the North American Neuromodulation Society. The analysis of the study, of which he was a co-investigator, showed a link between good pain control among the 69 patients who were followed for one year and reduced opioid use -- even though reducing opioid use was not an explicit goal of the study. (Pain Medicine News)

Company Whose Neurostimulator Addresses Sleep Apnea Looks to Raise $75 Million in Offering

April 23, 2018 - Terms of the initial public offering for Inspire Medical Systems were announced, with the device maker, which sells a neurostimulation system for obstructive sleep apnea, planning to raise $75 million by offering 5 million shares in a price range of $14 - $16. (Renaissance Capital)

Memory Enhancement Through Neurostimulation Draws Potential Commercial Interest

April 23, 2018 - A magazine article mentions two recently reported studies that demonstrated the effects of brain stimulation on memory encoding and recall in volunteers who were being monitored for epilepsy. The article mentions commercial interest from a startup and the prospect of potentially conducting clinical trials with a fully implantable device in the future. (Mach)

Acquisition Complete of Device Maker That Addresses Overactive Bladder

April 23, 2018 - The acquisition of Cogentix Medical, Inc. was completed by Laborie Medical Technologies at $3.85 per share. Cogentix, now a subsidiary, created the percutaneous tibial nerve stimulation system Urgent PC to address symptoms of overactive bladder. (The Virginian-Pilot)

Review Summarizes Spinal Cord Stimulation Clinical Trial Findings

May 2018 - International Neuromodulation Society members Nagy Mekhail, MD; Priya Agrawal, DO; and colleagues have published a review of 21 randomized controlled trials of spinal cord stimulation, providing outcome-specific evidence scores on aspects such as pain relief, quality of life, functional status, psychological impact, patient satisfaction and healthcare costs. (Regional Anesthesia and Pain Medicine)

Authors Observe Spinal Cord Stimulation Benefits Over Time on Function, Pain, and Quality of Life

April 19, 2018 - Clinicians in Italy, including International Neuromodulation Society members Angelo Lavano, MD; Furio Zucco, MD; Paolo Poli, MD; and Laura Demartini, MD, published longitudinal observations from the PRECISE study of 80 consecutive pain patients who received spinal cord stimulation for failed back surgery syndrome (FBSS). The patients were assessed and followed from 2005 to 2007, with 55 patients completing the 24-month assessment. The authors conclude that their results suggest patients whose FBSS is refractory to conventional medical management can obtain improvement in pain perception, functional ability and heath-related quality of life through spinal cord stimulation plus conventional medical management. (Health and Quality of Life Outcomes)

Data to Be Presented on Wrist-Worn Transcutaneous Neurostimulator for Essential Tremor Patients

April 19, 2018 - The American Academy of Neurology released two meeting abstracts in advance of its annual meeting about non-invasive devices, worn on the wrist, that stimulate the median and radial nerves to reduce involuntary hand motion in essential tremor patients. The findings will be reported at the meeting on April 25. (MedPage Today)

Studies Strive to Improve Hand Function After Paralyzing Spine Injury

March 30, 2018 -A profile of a researcher describes research at the University of California, Los Angeles into using epidural spinal cord stimulation to help spine-injured patients regain some use of their limbs and hands. The researchers recently published a pilot study about their research into improving hand function. (Los Angeles Magazine)

Non-invasive Brain Stimulation Improved Talk Therapy Results for Veterans with Post-Traumatic Stress Disorder

April 19, 2018 - In a sham-controlled trial, 103 combat veterans with PTSD were randomized to receive either active, or sham, repetitive transcranial magnetic stimulation prior to sessions of cognitive processing therapy, a cognitive behavioral therapy used for treating PTSD. The group that received active stimulation had significantly greater improvement for up to six months, according to the research team's findings, published in the Journal of Affective Disorders. (UT Dallas)

Quarterly Earnings Report Reflects Growth in Spinal Cord Stimulator Sales

April 18, 2018 - Abbott has attained the No. 1 sales position in the U.S. for spinal cord stimulation devices, industry analysts said at the conclusion of the first quarter of 2018. The company's $212 million in neuromodulation device sales represented nearly 19% organic growth. The neuromodulation business is expected to grow, but not necessarily spike, according to comments the CEO made during a quarterly earnings call. (Star Tribune)

Vagus Nerve Stimulation System for Epilepsy Receives CE Mark Approval in Europe

April 17, 2018 - LivaNova announced it has received CE mark approval for its vagus nerve stimulation system for treatment of drug-resistant epilepsy in the European Union. (Mass Device)

Article Examines Nuances of Deep Brain Stimulation for Depression

April 17, 2018 - An article examines research into deep brain stimulation for treatment-resistant depression, explaining an evolving perspective on patient and target selection and clinical trial timelines and turning points. (The Atlantic)

Neurostimulation Provider Says This Alternative to Opioids is Underutilized

April 17, 2018 - A local television segment about a back-pain patient and her doctor presents spinal cord stimulation for chronic pain as an underutilized option that can be an alternative to opioids. The segment focuses on sub-threshold stimulation as a relatively new treatment choice. (NBC 5 Dallas)

Bioelectronic Medicine Executive Discusses Therapy Potential

April 17, 2018 - The CEO of SetPoint Medical writes about medical devices playing a role in treating inflammatory disease through bioelectronic medicine. The company has begun clinical trials in rheumatoid arthritis and Crohn's disease, and has explored potentially addressing multiple sclerosis. (Mass Device)

Neurosurgeon in Dallas Describes Establishment of Deep Brain Stimulation

April 2018 - A news feature profiles a local neurosurgeon who provides deep stimulation in the Dallas, Texas area. The article describes the evolution of the technology and how it is becoming more commonplace. (D Magazine)

Interview with German Neurosurgeon Summarizes the State of Deep Brain Stimulation Treatment

April 15, 2018 - International Neuromodulation Society member Veerle Visser-Vandevalle, MD, PhD, was quoted in an article about deep brain stimulation for Parkinson's disease and other conditions. She said she hoped to make people less afraid of such an intervention by informing a wider audience about this work. (DW.com)

Column Advocates Patient-Centered Approach to Neuromodulation for Chronic Pain

April 13, 2018 - An article that mentions the importance of neuromodulation in the context of the growing opioid epidemic calls for physicians to respond to rapid evolution in the field by tailoring the therapy to individual patients. (NeuroNews)

Company Begins Listing on Public Stock Exchange

April 11, 2018 - Helius Medical announced a public offering on NASDAQ of 4.14 million shares at $7.47 per share, totaling $14.1 million. The proceeds will be used for commercialization activities for its portable neuromodulation stimulator device. The company anticipates regulatory submissions this quarter in the U.S., Canada, Australia, and the European Union. Potential indications include physical rehabilitation for brain injury or neurological conditions. (Medical Device Investing News)

Noninvasive Neurostimulator Launches in the United Kingdom

April 11, 2018 - The South African company Xavant Technology (Pty) Ltd. announced the launch, in the United Kingdom, of a noninvasive nerve stimulation device for relief of neuropathic pain and adjunctive treatment of post-surgical pain, post-traumatic acute pain problems, and pain control in rehabilitation. (Cision)

A New Brain Stimulation Approach Created Natural Sensations in Paralyzed Hands

April 10, 2018 - A paper in eLife reports the use of intracortical microstimulation to produce naturalistic sensations in the hands of a paralyzed patient. The researchers say they would like to next connect the implanted electrode arrays to prosthetics to potentially create better feedback control for the user. (Neuroscience News)

News Article in Nigeria Presents State of China-Made "Brain Pacemaker"

April 10, 2018 - International Neuromodulation Society member Luming Li, PhD, commented in an article about the spread of deep brain stimulation for Parkinson's disease in China, saying it has become an important method to treat patients in the middle and late stages. The article said the first China-made devices became available in China in 2009, and have been introduced to such countries as Pakistan, Bangladesh and Indonesia. (World Stage)

Device Maker Files Initial Public Offering

April 9, 2018 - Inspire Medical Systems Inc., whose neurostimulator to address obstructive sleep apnea received U.S. regulatory approval in 2014, has filed for an initial public offering to raise $86.2 million. (Minneapolis/St. Paul Business Journal)

Clinicians Investigating Deep Brain Stimulator for Motor Recovery from Stroke Receive $2.5 Million Grant

April 9, 2018 - The National Institutes of Health has given a $2.5 million grant to a team at Cleveland Clinic co-led by International Neuromodulation Society member Andre Machado, MD, PhD, to advance work using deep brain stimulation to improve post-stroke motor rehabilitation. (Crain's Cleveland Business)

Researchers Document Improvement in Primary Headache from Peripheral Nerve Field Stimulation

April 9, 2018 - International Neuromodulation Society member Satoshi Ayuzawa, MD, PhD, and colleagues published an article https://onlinelibrary.wiley.com/doi/abs/10.1111/ner.12772 about a study in which 54 patients with primary headache had improved pain and disability scores following three months of electroacupuncture peripheral nerve field stimulation of the C2 dermatome. (Neurology Advisor)

Newly Approved Spinal Cord Stimulator Implanted in Australia

April 9, 2018 - International Neuromodulation Society member Marc Russo, MD was interviewed in an article about the first chronic pain patient in Australia to receive a rechargeable spinal cord stimulator that was recently approved by the Therapeutic Goods Administration. (Nine.com.au)

News Article Summarizes Three Studies of Brain Stimulation for Alzheimer's Disease

April 8, 2018 - An article summarizing research into deep brain stimulation for Alzheimer's disease describes three completed or current clinical trials involving stimulation to the fornix, or to either the fornix or the the basal nucleus of Meynert. (Alzheimer's News Today)

Crossover Study Compares Spinal Cord Stimulation Frequencies in Relieving Low Back Pain

April 2, 2018 - A prospective, randomized crossover study of 24 patients with lower back pain concluded that 5882 Hz spinal cord stimulation can produce significant pain relief for axial low back pain, compared to lower frequencies and sham stimulation. Furthermore, sham stimulation produced similar analgesic effects to 1200 Hz and 3030 Hz. (Neuromodulation: Technology at the Neural Interface)

Retrospective Study Investigated the Effectiveness of Vagus Nerve Stimulation Plus Medication for Epilepsy

April 2, 2018 - Examining the effects of anti-epilepsy medication and vagus nerve stimulation over five years, researchers in Sweden analyzed 130 consecutive patients who were implanted between 2000 and 2013 with a vagus nerve stimulation (VNS) device for epilepsy. They said their data supports the idea that VNS effectiveness increases over time, and suggest that it should be evaluated for at least two years after implantation, with medication changes kept to a minimum during this evaluation period. (Neuromodulation: Technology at the Neural Interface)

Clinicians Publish Data on Peripheral Nerve Field Stimulation for Low Back Pain

April 2, 2018 - A 12-month follow-up on 50 patients with back and leg pain showed the addition of peripheral nerve field stimulation continued to provide statistically significant, clinically relevant relief of low back pain in patients for whom spinal cord stimulation relieved leg pain only. (Neuromodulation: Technology at the Neural Interface)

Article Summarizes Considerations Concerning Non-Invasive Devices to Address Migraine Pain

April 5, 2018 - An article briefly compares three non-invasive devices, approved relatively recently by the FDA, which are available by prescription for treatment of acute migraine pain. The article notes that insurance coverage differs by device and individual plan. Two of the devices are only available on a rental basis. The article adds that the FDA considers the devices low-risk. Experts commented that clinical experience is growing, and the devices expand options for patients, for instance, if their condition is not adequately controlled by medication, or medication causes intolerable side effects. (Neurology Today)

Prosthetic Hands Gain Tactile Feedback and Refined Control

April 3, 2018 - A news feature profiles emerging work by several companies to bridge prosthetic hands to the nervous system and use systems that refine control, such as machine learning, to provide more precise motor control as well as sensory feedback. (CNET)

Wearable Pain Relief Device Gathers Data

April 4, 2018 - NeuroMetrix began providing a wearable neurostimulation device for pain control in 2015, and gathers automated and self-reported data from about 50,000 contributors. In an interview, the CEO said the company has begun to analyze the digital health data that these contributors provide. (Medgadget)

Sacral Nerve Stimulation Developer Announces New Financing

April 3, 2018 - Axonics Modulation Technologies raised $40.1 million in financing. An equity offering provided $20.1 million and the remainder came from a new credit facility. The financing will support further commercial development of its sacral nerve stimulation system, which is intended to treat bladder and bowel disorders. (Mass Device)

Company Reports Findings Involving Its Hand-held Migraine Prevention Device

April 3, 2018 - The company eNeura reported publication in Cephalgia of findings from its migraine prevention study. The study at eight U.S. centers evaluated its handheld transcranial magnetic stimulation device. (Cision)

Child Receives Deep Brain Stimulation for Rare Movement Disorder

April 3, 2018 - A 9-year-old boy, with a movement disorder arising from a mutation to the GNAO1 gene, is one of less than 10 patients to receive deep brain stimulation for his condition. The robotic-assisted surgery was partially funded by a children's hospital charity. (Daily Mail)

Summary Recounts Evidence Concerning Neurostimulation in Cluster Headache

April 2, 2018 - A overview of cluster headache treatments summarizes emerging evidence about the potential for stimulation of the sphenopalatine ganglion to abort attacks. (Clinical Pain Advisor)

Gym Tries Out Consumer Transcranial Direct Current Stimulation Device

April 2, 2018 - A Hong Kong gym tried out a consumer headset that provides transcranial direct current stimulation. The month-long assessment concerns fitness-related technology that might be distributed to locations throughout the city. The article concludes that the device's novelty may spark motivation and the gains are an incremental effect. (South China Morning Post)

Guidelines Address Bleeding Control in Interventional Pain Procedures

April 2018 - Updated guidelines, on anticoagulation management for interventional pain procedures, have been published by an international team of authors. They update a 2015 version endorsed by the European Society of Regional Anesthesia and Pain Therapy, American Academy of Pain Medicine, the International Neuromodulation Society, North American Neuromodulation Society, and the World Institute of Pain. (Regional Anesthesia and Pain Medicine)

Video Shows Patient Playing Flute During Deep Brain Stimulation Surgery

March 31, 2018 - A medical center in Texas released a video of a 63-year-old dystonia patient playing her flute during deep brain stimulation surgery. Her use of her instrument helped to assess the effect of the stimulation. (Tech Times)

Article: Spinal Cord Stimulation Offers Hope for Chronic Pain Patients

March 29, 2018 - An article about recent spinal cord stimulation (SCS) describes recent offerings by four device companies, and says the therapy "sounds a lot scarier than it really is". The article adds that doctors are wary of prescribing opioids for chronic pain, which increases interest in SCS. (CNBC)

Patient Enrollment Begins in Feasibility Trial of "Microburst" Vagus Nerve Stimulation in Epilepsy

March 28, 2018 - LivaNova announced the first patient has been enrolled in its feasibility trial of its microburst vagus nerve stimulation system in epilepsy. (Mass Device)

Researchers Observe Subcortical Voltage Changes from Transcutaneous Direct Current Brain Stimulation

March 27, 2018 - Data from patients who have deep brain stimulation systems (DBS) indicate transcranial direct current stimulation produces electric fields at subcortical levels. The research was carried out after the initial implantation of the DBS leads, before they were connected to an implantable pulse generator. (Science Daily)

Article Recognizes Patient Care Team's Role in Intrathecal Drug Delivery

March 26, 2018 - An article that mentions the Polyanalgesic Consensus Conference treatment algorithm highlights findings from a literature search about the role of physician assistants, nurse practitioners and registered nurses in working with physicians to provide intrathecal drug delivery. (Pain Medicine News)

Meeting Recap Discusses Recently Approved Neurostimulator

March 23, 2018 - Several potential pain indications were presented at the 2018 annual meeting of the North American Neuromodulation Society for Nevro's Senza II spinal cord stimulation system, which received FDA approval in January. The potential indications include chronic, intractable neck and/or upper limb pain; peripheral polyneuropathy; and nonsurgical refractory back pain. (Pain Medicine News)

Company Starts Trial of Vagus Nerve Stimulation in Rheumatoid Arthritis

March 26, 2018 - SetPoint Medical announced it has begun a pilot trial in 15 subjects with drug-refractory rheumatoid arthritis in the U.S. The trial at seven centers will evaluate its rechargeable wireless vagus nerve stimulator that is intended to activate the body's anti-inflammatory reflex. (Business Wire)

Device Maker Announces MRI-Conditional Labeling

March 23, 2018 - Nevro said it received FDA approval for full-body MRI-conditional labeling for its Senza spinal cord stimulation system. (Mass Device)

Study Explores Possibility of Nerve-Based Approach to Treat Obesity

March 22, 2018 - A presentation at the Society for Interventional Radiology conference described a safety study of a possible nerve-based approach to weight loss. During an office visit, 10 moderately to severely obese people had their posterior vagal trunk "frozen" by a probe for two minutes. They were followed for 90 days. The group averaged an overall weight loss of 3.6%. A larger, controlled clinical trial is planned. (ABC News)

New Stimulation System for Cluster Headache Implanted at U.K. Center

March 21, 2018 - International Neuromodulation Society member Ashish Gulve, MD, was quoted in an article that announced use of a new device for occipital nerve stimulation. The AnkerStim lead and neurostimulation system was used in a patient in the U.K. who has cluster headache. (Gazette)

Column Introduces a Neurostimulation Device for Obstructive Sleep Apnea

March 21, 2018 - An article describes a new device, available in Utah for moderate to severe obstructive sleep apnea, that is implanted on an outpatient basis. (The Spectrum)

Paper Documents a New Research Tool for Studying Brain Function

March 21, 2018 - Researchers studying a new class of temperature-sensitive cation-channel proteins have shown the so-called "thermogenetic tools" can be used to regulate activity of individual neurons in the brain through changes in temperature. The researchers think their laboratory findings, demonstrated in fruit flies, may help inform advances in deep brain stimulation. The findings were published in Scientific Reports. (Science Daily)

Researchers Publish Findings About Neurostimulation in Spine-Injured Patients and Plan an Expanded Study

March 19, 2018 - Researchers have published findings of the effects of epidural spinal cord stimulation on blood pressure regulation in patients with spinal cord injury. They plan to expand the research and are recruiting 36 patients for a six-year study. The study will assess cardiovascular effects as well as motor rehabilitation. (Medical Express)

Company Plans Clinical Trial of Stimulator for Knee Replacement Pain Management

March 19, 2018 - Bioelectronics Corporation announced it is beginning a clinical trial in 40 subjects undergoing knee replacement. In it, patients will be randomized to receive a sham or active device for postoperative pain management and reducing hypersensitization during recovery. The device, RecoveryRx, delivers "pulsed shortwave therapy" at 27.12Mhz. Patients in the study, to take place at New Mazloum Hospital in Tripoli, Lebanon, will be followed for three months. (Nasdaq)

Agency Announces Research Program Into Non-Invasive Brain Devices

March 16, 2018 - The U.S. Defense Advanced Research Projects Agency, DARPA, announced a new four-year program, Next-Generation Nonsurgical Neurotechnology (N3), to demonstrate a bidirectional system for human-machine interactions in defense-related tasks. They are also looking into regulatory issues. (DARPA)

Device Company Outlines Plans for Its Spinal Cord Stimulation Systems, Sacral Nerve Stimulators, and Development of Deep Brain Stimulation Systems

March 13, 2018 - Nuvectra Corporation CEO Scott Drees was interviewed during the North American Neuromodulation Society meeting in January. In the interview, he said the company reached 1,000 implants of its spinal cord stimulation device Algovita in the U.S. in December 2017. The company is now talking about a four-arm clinical study comparing stimulation modes for the device. Meanwhile, it anticipates European approval of its sacral nerve stimulation system Virtis in the second quarter of 2018 and in the U.S., in the second half of 2018. Finally, the company has a development agreement with Aleva Neurotherapeutics to combine Nuvectra's implantable pulse generator technology with Aleva's lead technology, to create a deep brain stimulation system. (SmartTRAK)

In Study, Patients Compare Spinal Cord Stimulation Waveform Options

March 14, 2018 - An article summarizes results of the WHISPER study presented at the 2018 annual meeting of the North American Neuromodulation Society. In it, 70 spinal cord stimulation patients, with pain scores of at least 6 out of 10, tried subperception stimulation and superperception stimulation randomly for three months each. Given a choice after that, 55 patients chose subperception stimulation. These patients were followed for 12 months. (Pain Medicine News)

Government Program in France Will Help Fund a Study of Neurostimulation in Cluster Headache

March 13, 2018 - Autonomic Technologies announced the French National Authority for Health will support a randomized controlled trial of the company's sphenopalatine ganglion stimulation system in patients with cluster headache. The funding comes through the Forfeit innovation program, which is designed to accelerate introduction of promising medical technology and collect data for a longer-term reimbursement decision. (NeuroNews)

Case Study Reports Improved Blood Pressure Control from Spinal Cord Stimulation in a Spine-Injured Patient

March 13, 2018 - A case study reports effects of neuromodulation on a spine-injured patient with motor paralysis and autonomic symptoms, such as vertigo related to positional changes in blood pressure. With spinal cord stimulation in the lower back, the patient maintained stable blood pressure when moved to an upright position on a tilt table. The study appeared as a research letter online in February in JAMA Neurology. (Ubyssey)

Maker of a Neurostimulation System for Overactive Bladder Strikes Acquisition Agreement

March 12, 2018 - Cogentix Medical, the maker of the percutaneous tibial nerve stimulation system Urgent PC Neuromodulation System, has agreed to be acquired for $239 million in cash to become a wholly owned subsidiary of Laborie Medical Technologies. The acquisition represents a per-share premium of 28% over the average closing price of the company's stock over the last 30 days. The deal is expected to be completed early in the second quarter of 2018. (Equities.com)

Researchers Compare Awake vs. Asleep Deep Brain Stimulation for Parkinson's Disease

March 13, 2018 - International Neuromodulation Society members Lars Wojtecki, MD; Philipp Slotty, MD; Jan Vesper, MD; and colleagues have published a retrospective comparison of outcomes at three and 12 months in 96 patients with Parkinson's disease who received deep brain stimulation targeting the subthalamic nucleus. Half (48) of the patients were awake during the surgery and half were asleep. The comparison showed overall motor function improved faster in the awake group with the difference disappearing at one year. Freezing and speech symptoms, meanwhile, were worse after asleep surgery at three months and one year, respectively. (Neuromodulation: Technology at the Neural Interface)

Neurosurgeons Publish a Study Protocol for Deep Brain Stimulation to Address Morbid Obesity

March 12, 2018 - Clinicians in Brazil have published a feasibility study protocol for deep brain stimulation of the ventromedial hypothalamus in up to six patients with morbid obesity. According to the published information, weight loss of at least 3% will be considered adequate after three months of stimulation. (Neurosurgery)

Stroke Survivor Describes Her Neurostimulation Treatment During Rehabilitation

March 11, 2018 - An article features an interview with a stroke survivor in Scotland who has been using vagus nerve stimulation in conjunction with rehabilitation exercises to restore upper limb function. (The Sun)

Researchers Demonstrate a Stimulation Treatment for Tinnitus

March 11, 2018 - A double-blinded, sham-controlled, crossover study in 20 people with tinnitus showed that 28 days of bimodal stimulation reduced the loudness and intrusiveness of the disorder. Research in an animal model of tinnitus had shown that a pattern of combined auditory and somatosensory stimulation reduced activity of the cochlea nucleus, where fusiform cells integrate auditory and somatosensory inputs. The research was published in Science Translational Medicine. (Bel Marra Health)

Company Plans Clinical Trial of Implanted Tibial Nerve Stimulator for Overactive Bladder

March 9, 2018 - Valencia Technologies Corporation said it has won FDA approval to launch a pivotal clinical trial to evaluate its eCoin neurostimulation device in the treatment of overactive bladder. About the size of a nickel, the device would be implanted subcutaneously above the tibial nerve. The eCoin has electrodes integrated into its housing, which contains a small battery that is designed to deliver intermittent stimulation. (Mass Device)

New Clinical Trial Attempts to Restore Movement After Paralysis

March 8, 2018 - A spinal cord injury patient who became paralyzed in a fall while sleepwalking 11 years ago is one of the first participants in a Minnesota clinical trial of epidural spinal cord stimulation to restore volitional motor control. She said already she has regained some movement in her toes, and she hopes to continue using the device beyond the initial study period. (Jamestown Sun)

Column Describes Evolving Definition of Bioelectronic Medicine

March 2018 - A column describes bioelectronic medicine as being geared toward improving organ function, and suggests the taxonomy may later be based upon physiology rather than technology. It also raises the concept of "pricing device therapies by the dose, rather than hardware cost," which would be more familiar to professionals who originally worked in biopharmaceutical development. (Neurotech Reports)

Pilot Study Assessed Novel Transcranial Magnetic Stimulation Protocol in Complex Regional Pain Syndrome

March 4, 2018 - A pilot study of a novel transcranial magnetic stimulation (TMS) treatment in 21 patients with CRPS I or CRPS II showed at least 30% reduction in pain in more than half the participants, with four participants experiencing more than 50% pain relief beyond six to eight weeks. The authors found no difference in pain reduction between a single session or five consecutive sessions. Treatment consisted of intermittent theta-burst stimulation to the motor cortex, followed by 10 Hz high-frequency stimulation to deeper regions. The placement of the stimulating coil above the motor cortex was individualized based on the patient's pain location. (Neuromodulation: Technology at the Neural Interface)

U.S. Health Insurer to Cover Peripheral Nerve Stimulator

March 7, 2018 - Bioness Inc. announced its StimRouter peripheral nerve stimulation system has received coverage from Highmark Blue Cross Blue Shield, the fourth-largest Blue Cross Blue Shield provider in the U.S., for chronic intractable neurogenic pain. (PR Newswire)

More States Will Provide Medicare Reimbursement for Company's Retinal Prosthesis

March 6, 2018 - Second Sight Medical announced expanded Medicare reimbursement coverage for its Argus II retinal prosthesis system for patients with retinitis pigmentosa. This new coverage from Medicare Administrative Contractor Palmetto GBA applies to Alabama, Georgia and Tennessee. The coverage area now totals 31 states, two territories, and the District of Columbia. (Mass Device)

Article Features Neural Interface Research in Paralysis

March 4, 2018 - A news feature about the BrainGate research program, to restore some motion or function to paralyzed people with neural implants, highlights the project as being considered to be named one of 50 ideas with the potential to change the world. (Financial Times)

Past International Neuromodulation Society President Reflects on Progress of Field

March 2, 2018 - International Neuromodulation Society Emeritus Director-at-Large Simon Thomson, MBBS, FRCA, FIPP, a past president of INS, was interviewed about how he has seen the field of neuromodulation grow and change. He describes his interest in seeing neuromodulation be a standard of care for neuropathic pain, which "is associated with severe deficits of health-related quality of life and responds poorly to opioids," saying, "Neuromodulation must be positioned ahead of opioids. To do that it has to be much more accessible with shorter times from diagnosis of refractory pain to neuromodulation." (NeuroNews)

Study: Memory Improvement from Non-Invasive Brain Stimulation Seen in Younger, But Not Older, Adults

March 1, 2018 - A 96-person study of transcranial magnetic stimulation in two age groups -- adults over age 60 or under age 35 -- showed it improved the ability of study subjects to recall names associated with faces only in the younger group. The younger adults showed an average 50% improvement in memory, both immediately after the stimulation, and one day later. (Daily Mail)

Column: How Neurostimulation Treatment Can Gain Uptake

Feb. 27, 2018 - Writing as president of the International Neuromodulation Society, Timothy Deer, MD, published a column about neurostimulation as part of the solution to the opioid crisis. He lists ways to make the next decade the time of electrical medicine. Dr Deer says, "we now are ready to launch the modern world into a time when neurostimulation is thought of as a normal part of medical care." (NeuroNews)

Device Maker Announces Plans for Comparative Study of Nerve Stimulation Devices in Overactive Bladder Syndrome

Feb. 28, 2018 - StimGuard LLC announced it will initiate a U.S. head-to-head study of its implantable percutaneous tibial nerve stimulator, compared to sacral nerve stimulation, to address urgency urinary incontinence, in patients with refractory overactive bladder syndrome. (Business Wire)

Pain Patient Describes Back Pain Relief From Spinal Cord Stimulation in a Syndicated U.S. Television Talk Show

Feb. 20, 2018 - International Neuromodulation Society member Kasra Amirdelfan, MD, was interviewed with a pain patient on a five-minute television segment about medical treatments, discussing how she found relief for back pain from degenerative disc disease -- after having become more debilitated over 15 years despite escalating pain medication -- through trying a newer spinal cord stimulation system. (The Doctors via YouTube)

Pilot Clinical Trial Suggests Non-Invasive Brain Stimulation May Aid Therapy for Cerebral Palsy

Feb. 22, 2018 - A randomized, sham-controlled, blinded pilot clinical trial of rehabilitation for cerebral palsy in 20 patients aged 7 - 21 compared physical therapy alone to physical therapy plus transcranial direct current stimulation. Both groups improved hand strength over six months. The researchers noted that children whose brains retained connections to their weaker hand showed greater improvement specifically from the brain stimulation. (University of Minnesota)

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)

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)

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)

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)

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)

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)

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 Abbott 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.

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)

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)

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)

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)