Preliminary Scientific Program
Aug. 28, 2015 - Abstracts from the 12th World Congress of the International Neuromodulation Society in June in Montreal are now available in the online issue of Neuromodulation: Technology at the Neural Interface. (Neuromodulation: Technology at the Neural Interface)
Aug. 27, 2015 - BioControl Medical announced completion of enrollment in its INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) clinical trial that assesses its vagus nerve stimulation system in the treatment of congestive heart failure. The neurostimulation system includes a stimulator that targets the right vagus nerve in the neck, and a sensor that is place in the right ventricle of the heart. Enrollment began in 2011, and consists of 725 patients at 86 centers in the United States and Europe. In the randomized controlled study, for each three patients who are implanted with the CardioFit device, two are placed in the control group and receive standard, evidence-based management. The system is designed to stimulate the parasympathetic branch of the autonomic nervous system, in order to reduce stress on the heart. Based on an earlier pilot study, the system was CE certified in 2008. (Business Wire)
Aug. 27, 2015 - A team of researchers from Deakin University and the Mayo Clinic propose making biocompatible silicon enclosures for deep brain stimulation parts on a three-dimensional printer in a paper in Procedia Technology. (3D Print.com)
Aug. 27, 2015 - Select audio files and links to a number of slide presentations from the International Neuromodulation Society (INS) 12th World Congress are now available for members to access from the INS Members Only section of the INS website. Members may use their credentials to log on and access the material. (International Neuromodulation Society)
Aug. 27, 2015 - A retrospective review of 199 patients who received permanent spinal cord stimulator implants at one center between 2001 and 2011 found that at 6 and 12 months, all patients in all indications had lower numerical pain scores, and that oral morphine equivalents decreased significantly in patients treated for failed back surgery syndrome or complex regional pain syndrome. In addition, patient satisfaction was significant at one year for all groups. (Pain Practice)
Aug. 26, 2015 - The National Institutes of Health has given SPR Therapeutics a $1.6 million grant to study whether the company's peripheral nerve stimulation system could be used to control the post-operative pain of knee replacement surgery. Biospace reported that the company has received permission to undertake a clinical trial of the stimulation for up to 60 days in post-operative knee-replacement patients. (Crain's Cleveland Business)
Aug. 26, 2015 - Mainstay Medical International plc announced issuance of a new U.S. patent, “Apparatus and Methods for Rehabilitating a Muscle And Assessing Progress of Rehabilitation.” The company is developing a new implantable neurostimulation system to treat chronic low back pain. (Business Wire)
Aug. 25, 2015 - A long-term follow-up of 24 patients with treatment-resistant obsessive compulsive disorder indicates that deep brain stimulation of the bed nucleus of the stria terminalis is a promising therapeutic option, according to a journal article by researchers in Belgium. (Molecular Psychiatry)
Aug. 25, 2015 - People in the eastern part of Scotland who have had to travel to England to receive deep brain stimulation surgery and follow-up care may no longer have to if a proposal for a single national service in Scotland is adopted when it is considered next month, according to a news report about the issue. The site under discussion for the service is the new Queen Elizabeth University Hospital in Glasgow. The article quotes patients who have had to travel to Newcastle in England for this type of care. (BBC News)
Aug. 24, 2015 - St. Jude Medical Inc. announced receiving CE Mark approval for magnetic resonance imaging-conditional labeling of its soon-to-be-launched implantable pulse generator, the Prodigy MRI chronic pain system, saying the approval applies with select leads. (Business Wire)
Aug. 24, 2015 - Mainstay Medical International plc has secured $15 million in debt financing for commercialization of its neurostimulation device that is designed to address low back pain by contracting the muscles that provide stability. The funding from IPF Partners includes milestone payments for progress toward CE Mark approval of the device for the Dublin-based company. (Business Wire)
Aug. 21, 2015 - A research group at the China Academy of Chinese Medical Sciences in Beijing has published a clinical trial protocol to compare six months of daily treatment using two potential interventions in pediatric epilepsy, transcutaneous auricular non-vagus nerve stimulation (tan-VNS), or transcutaneous auricular vagus nerve stimulation (ta-VNS). The two treatment arms will be compared to a control group. (Trials)
Aug. 19, 2015 - An article describes one man's deep brain stimulation surgery as part of a 10-person clinical trial that investigates addressing treatment-resistant depression with stimulation to the supero-lateral branch of the medial forebrain bundle. (Houston Chronicle)
Aug. 19, 2015 - A company that is developing a therapy for loss of the visual field that involves 10 daily sessions of non-invasive electrical brain stimulation, EBS Technologies of Berlin, has raised 1.1 million Euros. The external device, operated by a technician, delivers alternating current to the retina. The stimulation is intended to activate the optic nerve and visual cortex, with the stimulation adjusted in response to monitoring of the patient's EEG. (Market Watch)
Aug. 17, 2015 - Beaumont Hospital in Royal Oak, MI highlighted three presentations made by urologist Ken Peters, MD, at the International Neuromodulation Society 12th World Congress in June about neuromodulation for bladder dysfunction and pelvic pain. (Newswise)
Aug. 18, 2015 - A single-blind, sham-controlled study of 24 healthy subjects showed that a commercial transcranial direct current stimulation device decreased cognitive performance on a standard test of working memory. (Experimental Brain Research)
Aug. 17, 2015 - Stanford University researchers have demonstrated that a fully enclosed implant can deliver light stimulation to the leg-muscle nerves of a mouse, powered by the animal's own body. (Stanford Report)
Aug. 17, 2015 - A 5-year-old boy born without a cochlea is participating in a clinical trial of pediatric patients who are receiving auditory brainstem implants to provide some sense of sound. The procedure had been previously approved in the U.S. for patients 12 years and older with neurofibromatosis type II. (The Blaze)
Aug. 14, 2015 - In a lecture at the National Institute of Mental Health concerning patients who participated in clinical research of deep brain stimulation for depression, Neurologist Helen Mayberg said that mapping white matter connections around Area 25 in the brain has guided stimulation parameters and demonstrated that initial non-responders can be converted to responders. She added that response rates using refined new methods now exceed 70% in a recent studies of 13 new patients. (NIH Record)
Aug. 13, 2015 - A product design innovator in the U.K., Cambridge Consultants, is publicizing its vision of future neuromodulation devices that it says might address what a news column terms "lifestyle" issues -- such as migraine, obesity and incontinence. (Business Weekly)
Aug. 13, 2015 - Second Sight Medical will get a new CEO this month when Robert Greenberg, MD, PhD steps down from that position and becomes chairman of the board, replacing Alfred Mann who will become chairman emeritus. The new CEO, Will McGuire, was an executive at medical-device-industry companies Volcano, Covidien and AtheroMed. An article notes that Greenberg had said the company intends to treat most types of blindness, such as glaucoma and diabetic retinopathy. The company's next-generation device "would bypass the retina with an electrode array implanted directly on the portion of the brain that deals with signals from the retina." (Mass Device)
Aug. 11, 2015 - A post-hoc analysis of patients involved in a pilot study of deep brain stimulation in early Parkinson's disease shows the therapy may reduce the risk of the condition worsening in clinically important ways by 50-80% .(Parkinsonism & Related Disorders)
Aug. 12, 2015 - Assessing the network effects of deep brain stimulation will be critical to better understanding the underlying pathophysiology of various brain disorders, according to a review of the literature concerning studies using cerebral blood flow and metabolic imaging, functional imaging, and electrophysiology (including scalp and intracranial electroencephalography, and magnetoencephalography). (Journal of Neurophysiology)
Aug. 11, 2015 - Dublin-based Allergan announced it has closed its purchase of dry-eye disease, neuromodulation-device developer Oculeve for $125 million in up-front payments plus commercialization milestone payments. (Mass Device)
Aug. 6, 2015 - An analysis of the scientific literature about functional electrical stimulation in children with spinal cord injuries or cerebral palsy examined three systematic reviews, six randomized controlled trials, and six non-randomized studies. The analysis concluded that the majority of studies found the intervention to be effective and well-tolerated by patients. (Canadian Agency for Drugs and Technologies in Health)
Aug. 3, 2015 - A five-year follow-up study of deep-brain stimulation of the anterior nucleus of the thalamus in epilepsy suggests seizure control improves with time and notes that there may be greater benefits in patients with temporal lobe epilepsy compared to frontal lobe epilepsy, with reductions in seizure frequency of 76% and 59% respectively. (Epilepsy Currents)
Aug. 11, 2015 - A double-blind, randomized, sham-controlled clinical trial has begun that will investigate the safety and effectiveness of a noninvasive cranial nerve stimulation device to augment physiotherapy for a chronic balance deficit due to mild-to-moderate traumatic brain injury. The device stimulates cranial nerves through the tongue, and the study is intended to precede marketing approval applications in the U.S. and Canada. The clinical trial of up to 120 subjects is taking place in Montreal, the Pacific Northwest, and Orlando, Florida through Helius Medical Technologies and the U.S. Army Medical Research and Materiel Command. (Business Wire)
Aug. 10, 2015 - The UK epilepsy health research charity announced plans to work alongside the National Health Service in England with hope of overturning a recent decision to not allow deep brain stimulation in refractory epilepsy. It had been expected that a handful of cases would be allowed each year. Now only patients in clinically critical need may be considered as exceptions. Provision of the treatment had been sought by the health charity because it can help reduce seizure activity. (The National Society for Epilepsy)
Aug. 10, 2015 - A news column describes research into brain-to-brain communication using brain-computer interfaces and non-invasive stimulation. Some researchers interested in this area are also looking into trying to create networks of linked individuals (such as laboratory research animals), or develop brain-wave synchronization; while others hope to apply insights to better understand the neural basis of social behavior. (Irish Business Times)
July 30, 2015 - A 13-year-old girl with epilepsy was the first in Minnesota to receive a vagus-nerve-simulation-system implant that provides stimulation based on sensing changes in heart rate. The device was FDA approved in June. (KARE)
July 30, 2015 - Greatbatch Inc., proposes a tax-free spin-off of its subsidiary, the QiG Group, into a medical device company, Nuvectra Corporation. In a Form 10 registration statement filed with the U.S. Securities and Exchange Commission, Greatbatch said neuromodulation industry veteran Scott Drees will be chief executive officer of Nuvectra; and Joseph A. Miller, Jr., PhD, its director and chairman of the board. (Globe Newswire)
July 30, 2015 - In a study funded in part by the National Institutes of Health, researchers in California and Russia have demonstrated the ability of five men with complete motor paralysis to make voluntary step-like movements after about 18 weekly sessions of noninvasive electrical stimulation to their spinal cord. The results, published in the Journal of Neurotrauma, reportedly represent the first time this voluntary motion was achieved using transcutaneous stimulation. The lead researcher was quoted as saying he is interested in finding if autonomic functions may also be enhanced with similar therapy, saying the studies seem to have reawakened some networks and could contribute to a clinical toolbox to aid patients by widening the selection of available therapies. (EurekAlert)
July 29, 2015 - An article summarizing a recent workshop on noninvasive neuromodulation says there is increasing interest from clinicians, patients, health systems, payers and industry. Although these devices may lead to more personalized care, the article says, their use could blurr the distinction between medical and non-medical approaches, which could potentially make it harder to develop an evidence base. (Medscape)
July 28, 2015 - A randomized controlled clinical trial reported in Anesthesiology showed a superior response rate for high-frequency spinal cord stimulation, compared to traditional, in back or leg pain among 171 study subjects at three months. The ratio of responders was 1.9 for back pain and 1.5 for leg pain. The authors report that the superiority was sustained through 12 months. (UPI)
July 28, 2015 - Co-authors who reviewed the charts of 50 patients who received sacral neuromodulation to treat neurogenic lower urinary tract dysfunction conclude that the treatment might be an additional therapy option in carefully selected patients. They report that 94% of the patients who received a permanent implant were either very satisfied or satisfied with the therapy. (Spinal Cord)
July 28, 2015 - A sham-controlled clinical trial of deep brain stimulation (DBS) to the ventral capsule and ventral striatum failed to show a significant difference in reduction of depression symptoms, according to results published in Biological Psychiatry. The clinical trial involved 30 patients. After 16 weeks, three of 15 patients (20%) responded to active stimulation, while two of 14 patients (14.3%) improved in the control group. Patients then entered a two-year open-label phase, in which the response rate was 20%, 26.7%, and 23.3% at 12, 18, and 24 months. The authors suggest that alternative study designs and stimulation parameters might be considered. (EurekAlert)
July 27, 2015 - International Neuromodulation Society member Simon Thomson, MBBS FRCA FIPP FFPMRCA, was quoted about the importance of early detection and a multi-disciplinary approach in an article about a patient with complex regional pain syndrome who received dorsal root ganglion stimulation for her condition. (The Guardian)
July 16, 2015 - In preclinical brain-stimulation research, a team reports developing wireless optofluidic neural probes that combine ultrathin, soft microfluidic drug delivery with cellular-scale inorganic light-emitting diode arrays. The researchers say they demonstrated these devices in freely moving animals "to modify gene expression, deliver peptide ligands, and provide concurrent photostimulation with antagonist drug delivery to manipulate mesoaccumbens reward-related behavior." (Cell)
July 24, 2015 - Interim results were presented at the Alzheimer's Association International Conference regarding a Phase II clinical trial of patients with early Alzheimer's disease who were implanted with deep brain stimulation (DBS) systems targeting the fornix, a part of the memory circuit. Half of the 42 patients in the clinical trial did not have their DBS system turned on for the first 12 months. Results from the first year show similar changes in cognitive measures between the two groups. Evalulation of the two groups will continue for four years. The researchers said an examination of trends among subgroups, who showed differences in glucose metabolism, can inform the design of future clinical trials. (Medpage Today)
July 23, 2015 - In a "Beyond the Abstract" feature, authors say they found that sacral nerve stimulation that is guided solely by motor provocation during the implant procedure is more straightforward and requires less reprogramming, compared to procedures that include guidance from sensory feedback from patients. They encourage consideration of prospective studies to confirm those results. Their observational study appeared online in Neuromodulation: Technology at the Neural Interface in April. (Uro Today)
July 22, 2015 - Twenty patients who never had been treated for their infrequent migraine without aura were enrolled in a safety-and-efficacy trial of transcutaneous supraorbital neurostimulation. These patients used the device more than 2/3rd of the time expected and experienced fewer migraine attacks and migraine days, with most having a reduction in symptoms of at least 50%. (The Journal of Headache and Pain)
July 21, 2015 - A meta-analysis of clinical trials of transcranial direct current stimulation for neuropathic pain resulting from back injury indicated a moderate effect that was not maintained at follow-up. (Spinal Cord)
July 21, 2015 - A physiotherapy professor at the Graduate School of Health at the University of Technology Sydney is conducting clinical research into non-invasive brain stimulation for dystonia. She is comparing transcranial magnetic stimulation in neck dystonia and earlier results of transcranial direct current stimulation in patients who have hand dystonia. She anticipates later combining brain stimulation with more traditional physiotherapy treatments. (Brisbane Times)
July 20, 2015 - Ten daily sessions of repetitive transcranial magnetic stimulation reduced tinnitus symptoms in a randomized, blinded, placebo-controlled clinical trial carried out and funded by the Veterans Affairs Rehabilitation Research and Development Service in Portland, OR. The study involved 64 participants, half of whom received sham stimulation. The responder rate in the active stimulation group was 56% and in the sham stimulation group, 22%. The symptom improvement seen in the group that had active stimulation was sustained for 26 weeks, according to the researchers' paper in JAMA Otolaryngology – Head & Neck Surgery. (Pharmabiz.com)
July 2015 - A case report describes an effect on irritable bowel syndrome (IBS) that was noticed in a woman who received deep brain stimulation (DBS) to the anterior limb of the internal capsule for obsessive compulsive disorder. The patient reported substantial relief of her IBS symptoms after DBS. The authors noted in their report that "the reduction depended on specific stimulation parameters, was reproducible over time, and was not directly associated with improvements in obsessive compulsive disorder symptoms." (Clinical Gastroenterology and Hepatology)
July 16, 2015 - The FDA has approved St. Jude Medical's Invisible Trial System, which patients can control with an iPod Touch and clinicians can program and track with an iPad Mini. The wirelessly controlled trial spinal cord stimulation system includes a small external pulse generator. (Fierce Medical Devices)
July 15, 2015 - Mainstay Medical International plc announced issuance of two U.S. patents concerning its neurostimulation therapy for chronic low back pain. The company's device stimulates muscles in the lower spine to provide more control over these stabilizing muscles. (Business Wire)
July 15, 2015 - An article about a prototype neurostimulator-delivery tool in development by Cambridge Consultants says the Chimaera hand-held instrument is designed to be used in conjunction with a wearable optical device such as Google glass to provide the operator a visual overlay of the target area. It combines pre-operative 3D imaging and real-time sensing of nerves. (Reuters)
July 14, 2015 - Bioness, Inc. received clearance from the U.S. Patent Office for a patent claiming use of high-frequency stimulation with its implantable peripheral nerve stimulation device, StimRouter. The device is FDA-approved to treat chronic, intractable pain of peripheral nerve origin as an adjunct to other modes of therapy. (Business Wire)
July 13, 2015 - International Neuromodulation Society (INS) member Andre Machado, MD, PhD, was interviewed about his preclinical studies into the potential for deep brain stimulation to aid in stroke rehabilitation. INS member Konstantin Slavin, MD, was also quoted in the story about unanswered questions posed by the potential to translate the findings through possible future clinical trials. (Wall Street Journal)
July 12, 2015 - A man who has been chronicling his exploration of whether to have spinal cord stimulation decides to go forward with a permanent implant. (National Pain Report)
July 11, 2015 - Researchers undertook a safety study of a novel approach to rehabilitation for foot drop in patients who had chronic impairment from stroke. They had nine study participants use an EEG cap while the peroneal nerve was stimulated. Over the course of 12 hour-long sessions, patients followed cues to flex or relax their foot. A post-hoc analysis suggests there was statistically significant, but not clinically significant, improvement of lower motor performance such as gait speed, walk distance and range of motion. (Journal of Neuroengineering and Rehabilitation)
July 9, 2015 - International Neuromodulation Society member Yun Guan, MD, PhD, and colleagues write that they have developed a simple simulation test bed that goes beyond existing models by including fundamental underlying sensory activity transmitted in dorsal column fibers. They say they have found so far that "interactions between stimulation-evoked and underlying activities are mainly due to collisions of action potentials and losses of excitability due to the refractory period following an action potential." (Cornell University Library)
July 9, 2015 - A study presented at the American Society of Clinical Psychopharmacology annual meeting in Miami indicates external trigeminal nerve stimulation may help alleviate symptoms of major depressive disorder. In the study, 43 patients were randomly assigned to active or sham treatment for six weeks. Patients wore electrode patches for eight hours at night. Data collected at six weeks showed that symptoms, and their severity, improved on average after six weeks in patients who had failed at least one antidepressant. The treatment was originally investigated for drug-resistant epilepsy, and later has been explored for potential efficacy in psychiatric disorders like depression, PTSD, and ADHD. (Medscape)
July 9, 2015 - A 4-year-old girl who was born without a cochlea and auditory nerve had an auditory brainstem implant at 23 months of age, and is making progress in understanding spoken language. (Daily Mail)
July 8, 2015 - A column recaps brain research into increasing responsiveness of patients who are in a minimally conscious state, including findings from investigations involving deep brain stimulation. (Wall Street Journal)
July 6, 2015 - Authors of a scholarly article propose that excess extracellular potassium may mediate some effects of deep brain stimulation, through affecting inhibition and excitation of cells and axons, thereby interrupting pathological activity. (The Neuroscientist)
June 26, 2015 - International Neuromodulation Society member Robert van Dongen, MD, PhD, and colleagues report a 24-month follow-up of a prospective randomized controlled trial of spinal cord stimulation in painful diabetic peripheral neuropathy. From 17 patients who were implanted after a positive trial stimulation phase at two centers, 11 (65%) reported treatment success at 24 months. (Diabetes Care)
July 7, 2015 - Helius Medical Technologies, Inc.'s NeuroHabilitation Corporation division has entered into a cost-sharing contract with the U.S. Army Medical Research and Materiel Command to support a clinical trial investigating the safety and effectiveness of the company's non-invasive Portable Neuromodulation Stimulator (PoNS™) for the treatment of balance disorder in patients with mild-to-moderate traumatic brain injury. The (PoNS™) device is placed on the tongue to stimulate cranial nerves that innervate muscles there. (Business Wire)
July 6, 2015 - Allergan of Dublin, Ireland will pay $125 million acquire South San Francisco-based Oculeve, a development-stage company that is developing a nasal neurostimulation device designed to increase tear production in patients with dry eye disease. The deal includes milestone payments for development of Oculeve's OD-01 neurostimulation therapy. Two pivotal trials are planned, with commercialization potentially occurring in 2017 after FDA approval, the company said. (Mass Device)
To see select neuromodulation news by category, as well as news about the INS in particular, please visit the Newsroom. To see archived news briefs dating back to January 2011, visit the News Archive.
How Has Neuromodulation Been Developed and Used?
Conventional medicine has typically had four modes of treating diseases or disorders: counseling or “talk therapy”; physical therapy involving manipulation and strengthening of muscles and range of motion; pharmaceuticals that act on a chemical level; and altering or augmenting tissue through surgery, injections, or filtering methods like dialysis. The growing field of neuromodulation is a new class of therapies that involves directly treating the nervous system itself, often through small implanted devices that target a specific area, to rebalance the activity of neural circuits and manage symptoms.
Progress has been spurred by advances in our understanding of the nervous system, as well as new technologies and clinical experience, enabling treatments to modify nerve cell activity in brain, spinal cord and periphery to restore function, minimize pain, and treat disease symptoms. Developed over the last 45 years, neuromodulation has grown rapidly into a family of therapies that applies stimulation or agents directly to the nervous system, often using small implanted medical devices that are powered in a similar fashion to a cardiac pacemaker. By delivering electrical or chemical stimulation, neuromodulation has increasingly been used to treat motor disorders such as Parkinson’s disease, refractory chronic pain ranging from neuropathy to cancer related pain to severe headaches, spasticity, epilepsy, and incontinence. It is also under study for conditions ranging from gastroparesis to medically refractory depression. Providers of such therapies include neurosurgeons, pain physician specialists and rehabilitation physicians. They may often work with other specialists such as neurologists, psychiatrists, psychologists, gastrointestinal or colorectal specialists, urologists, primary care physicians, and physical therapists to achieve best outcomes.
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Medical Professionals can learn about various considerations concerning neuromodulation and clinic contacts. Once your preliminary questions have been answered, please use the Contact Us facility to find out more and to discuss specific objectives. Others may simply wish to join the INS and one of its related chapter societies, please use Membership Application.
Clinical trials that involve a wide range of emerging neuromodulation approaches are listed on our Resources and Research pages. Neuromodulator trials address symptom control through nerve stimulation in such condition categories as:
If you are not a medical professional and you are searching for information about neuromodulation and how these types of treatment could benefit a specific condition such as treatment-resistant headache or other chronic pain syndromes, you may find the sections titled Therapies, About Neuromodulation or FAQs particularly helpful.
The International Neuromodulation Society (INS) is a non-profit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation - the alteration of nerve activity through the delivery of electrical stimulation or chemical agents to targeted sites of the body. Founded in 1989 and based in San Francisco, CA, the INS educates and promotes the field through meetings, its peer-reviewed journal Neuromodulation: Technology at the Neural Interface, explanatory content, and chapter websites.
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