INS 11th World Congress in Berlin
Retrospective Analysis Indicates Spinal Cord Stimulation Success Increases When Started Within Two Years
March 6, 2014 - International Neuromodulation Society member Krishna Kumar, MD, presented a poster at the annual meeting of the American Academy of Pain Medicine showing that in 443 patients with chronic pain, those who waited less than 2 years for spinal cord stimulation had a 75% success rate, compared to 15% for patients who waited 20 years, (American Academy of Pain Medicine)
Clinical Trial Starts That Pairs Audio Tones and Vagus Nerve Stimulation to Reduce Tinnitus Symptoms
March 6, 2014 - The National Institutes of Health is starting a study that pairs vagus nerve stimulation and exposure to audio tones to try to reduce symptoms in patients who have moderate to severe tinnitus. The vagus nerve stimulation, provided by a device manufactured by MicroTransponder, Inc., is supposed to help re-wire the brain in response to the audio stimulation that is intended to reduce the perception of ringing in the ears that occurs in tinnitus. The clinical trial at four U.S. centers involves daily 2.5-hour sessions over six weeks. (Health Day)
Company Formed to Commercialize Implantable System Conducive to Infusion of Biologic Agents
March 6, 2014 - The Alfred Mann Foundation announced creation of a Minnesota-based life sciences company to commercialize an implantable infusion pump that provides capability for delivery of large molecules associated with emerging biologic therapies for neurodegenerative diseases. The new company, Medallion Therapeutics, is conducting a pivotal clinical evaluation for pre-market approval of the device in the United States, and is pursuing CE Mark certification in Europe. The foundation said in a news release that the technology is the result of more than 10 years of development, and could address unmet need and expand indications for implantable drug delivery. International Neuromodulation Society member Don Deyo, a seasoned industry executive, is chief executive officer, and Eric S. Harris, also an industry veteran, is chief commercial officer. (Jewish Business News)
Physician Describes New Experiences with Auditory Brainstem Implants in Children
March 4, 2014 - An interview, an implanting physician describes the intricacies of new work in the United States with auditory brainstem implants for children who lack the neural structures for a cochlear implant. Three pediatric patients have been implanted so far by Craig Buchman, MD, professor of Otolaryngology and Head and Neck Surgery at the University of North Carolina School of Medicine, who directs the university's Ear and Hearing Center. (Ivanhoe Newswire via My Suncoast)
Transcranial Magnetic Stimulation Research Indicates Greater Plasticity in Brains of Insomniacs
March 4, 2014 - A research study comparing the ease of training insomniacs on a motor task to controls suggests that insomniacs may have a more-plastic brain. The study used transcranial magnetic stimulation (TMS) to the motor cortex to trigger a thumb movement. Subjects were asked to learn to counter the movement. Although it was hypothesized that insomniacs would be less-rested and do more poorly, they surprisingly did better, suggesting there is an association between this plasticity and "dysregulation of arousal" seen in insomnia. Potentially TMS might be used to treat insomnia, according to the author of the study at Johns Hopkins University. (Live Science)
Texas Medical Center Initiates Study of Emerging Deep Brain Stimulation Target in Treatment-Resistant Depression
March 4, 2014 - A clinical trial is starting at the University of Texas Health Science Center at Houston in which five adults with treatment-resistant major depression will receive deep brain stimulation to the supero-lateral branch of the medial forebrain bundle, part of the brain's reward system between the limbic system and prefrontal cortex, an area that showed promise in a Bonn-based pilot study in seven patients in which preliminary findings were published in June 2013. (Newswise)
Concern About Medicare Distinctions Potentially Curbing Research into Deep Brain Stimulation
March 3, 2014 - International Neuromodulation Society member Andre Machado, MD, PhD, and co-authors point out that a centralization of Medicare reimbursement policies for investigational medical devices, instituted in January 2014, offers two investigational device exemption categories, neither of which balances well reflecting potential therapeutic risks of applying these devices to emerging targets and indications while also being conducive to investment in development of these therapies. (Journal of the American Medical Association)
Deep Brain Stimulation Associated with Neural Stem Cell Proliferation in Parkinson's Disease Patients
March 3, 2014 - A comparative post-mortem tissue examination of the brains of individuals without Parkinson's disease, those with Parkinson's disease who did not receive deep brain stimulation (DBS), and 12 patients who had idiopathic Parkinson's disease and received deep brain stimulation from 0.5 - 6 years before dying of other causes showed that there was a 2-6 fold greater cell proliferation in the subventricular zone of the lateral ventricles, an area of neural stem cell growth that lies close to the electrode trajectory, in the brains of the subjects who had DBS. The results suggest DBS may increase cellular plasticity, potentially in areas beyond the electrode location. The effects on Parkinson's disease symptoms and therapy are not clear. (PLoS ONE)
Effects of "Asleep" Deep Brain Stimulation Surgery Comparable Over Time to "Awake" Method for a Common Parkinson's Disease Brain Target
March 3, 2014 - Of 213 patients who received deep brain stimulation surgery targeting the subthalamic nucleus for management of Parkinson's disease symptoms while under general anesthesia, 188 were followed up after one year and 65 after five years. The resulting short-term and long-term motor effects were similar to intervention under local anesthesia, the authors state, and there were no more adverse effects. (Journal of Neurology, Neurosurgery & Psychiatry)
Neuromodulation: Technology at the Neural Interface Adds an Enhanced Article Web Interface
March 3, 2014 - The International Neuromodulation Society journal, Neuromodulation: Technology at the Neural Interface, has added a new Enhanced Article (HTML) viewing option, accessible for logged-in readers from the Table of Contents page, that facilitates online viewing on any mobile interface, from as small as the screen of a smart phone to larger-sized devices. Called "Anywhere Article," the capability from publisher Wiley-Blackwell also allows readers to offer feedback or suggestions about the new display option. INS and chapter members may read the journal by logging in at http://www.neuromodulation.com/login and clicking on the image of the journal at the member menu item "Read Neuromodulation Journal Online" (International Neuromodulation Society)
Researchers Describe Early-Stage Neurostimulation Research in Anorexia Nervosa
March 3, 2014 - The start of a Phase II trial of deep brain stimulation in anorexia nervosa, is described by Toronto-based researchers who have implanted 15 adults with chronic, treatment-resistant, or malignant cases of the eating disorder. Based on experience tracking response in depression to stimulation of the anterior cingulate, the team is focusing on the subcallousal cingulate of the anterior cingulate, noting that mood appears to be involved in the pathogenesis of anorexia nervosa. Another six patients have been enrolled and were awaiting surgery. (Psychiatric Times)
Biological Chemist in Munich Publishes Research Papers on Potential "Light Switches" for Sensory Processing
March 2, 2014 - A biological chemist has developed a light-sensitive compound, DENAQ, that acts on specific ion channels in response to white light, which has allowed it to restore light-sensitivity in the eyes of blind mice. The research on electrophysiological remodeling of mouse retinal ganglion cells was published Feb. 19, 2014 in Neuron; in Angewandte Chemie on Feb. 12, 2014, his research group showed that the painkiller fentanyl, when modified with an azobenzene unit, will bind opioid receptors and change shape when exposed to different frequencies of light, activating or deactivating receptor function. (Ludwig-Maximilians-Universität München)
March 1, 2014 - International Neuromodulation Society member Kaare Meir, MD, PhD and colleagues in Denmark studied 26 chronic pain patients who received spinal cord stimulation, measuring both the area of spontaneous neuropathic pain and the pain intensity. The study found a correlation in increased quality of life with decreased pain intensity, but not with decreased area of spontaneous pain. (Clinical Journal of Pain)
Feb. 26, 2014 - Using low-level transcranial direct current stimulation that makes neurons more or less likely to fire, a clinical research team was able to elicit briefly increased levels in awareness in 15 of 55 study subjects who had shown fluctuating awareness ("minimally conscious state") or an ability to be aroused but not aware (vegetative state). In the crossover trial published online in Neurology, patients received 20 minutes of active or sham stimulation to the dorsolateral prefrontal cortex one day, and then crossed over to sham or active stimulation, respectively, the next. The responders included 13 brain-injury patients who were in minimally conscious state and 2 who had been classified as being in a vegetative state. (New Scientist)
Feb. 20, 2014 - The National Pain Foundation has re-emerged as a nonprofit organization, having transferred its assets to the American Pain Foundation in 2010, which disbanded in 2012. The National Pain Foundation announced a goal of creating a "digital footprint" of people in pain, their behaviors, treatments, and needs -- through online communities, surveys and forums. (Pain Medicine News)
Feb. 25, 2014 - Saying neuromodulation is poised for major growth in the coming years, Fierce Medical Devices provides an overview of the four main global competitors -- Medtronic, Inc., Boston Scientific Corporation, St. Jude Medical, and Cyberonics, Inc. Part of the anticipated growth, the article says, would come from wider and long-term use of neuromodulation therapies. (Fierce Medical Devicesl)
Feb. 20, 2014 - International Neuromodulation Society member Jonathan Carlson, MD, will be offering a peripheral nerve stimulation technique for chronic migraine in the Phoenix, Arizona area, according to a news release from the Migraine Treatment Centers of America. (Digital Journal)
Feb. 20, 2014 - Cyberonics, Inc. has received CE Mark approval for its 6th-generation generator for vagus nerve stimulation, the AspireSR generator, which provides automatic stimulation in response to detection of a seizure as indicated by an increase in heart rate. (Wall Street Journal)
Feb. 20, 2014 - Stroke patients who receive brain stimulation and occupational therapy recovered more than twice the arm and hand movement six months after their stroke than those who received occupational therapy alone, according to research presented at the American Stroke Association's International Stroke Conference 2014. (Clinton Herald)
March 2014 - Repetitive transcranial magnetic stimulation (rTMS), deep rTMS, and deep brain stimulation are discussed as possible interventions for cocaine dependence in an article that also suggests potential genetic markers for risk and objective treatment outcome measures. (Addictive Disorders & Their Treatment)
Feb. 20, 2014 - A columnist calls electroCore's external vagus nerve stimulation system "digital health's big secret" and adds that the company is working on a screening tool to predict responders. (Forbes)
Feb. 19, 2014 - Cyberonics, Inc.'s Chief Financial Officer Greg Browne will meet individually with investors and participate in a neuromodulation panel discussion in New York City next week. The panel takes place Feb. 26 at the Citi 2014 Global Healthcare Conference. On March 11, the company's president and chief executive officer, Dan Moore, will present at the Barclays Global Healthcare Conference in Miami, with a live audio webcast available from the company's website, http://www.cyberonics.com, at 2:30 PM Eastern Time. (Market Watch)
Feb. 18, 2014 - Animal research and evaluations of patients who received deep brain stimulation for treatment resistant depression indicate that immediate symptom relief is mediated by local inflammation, suggesting that post-surgical analgesics that are not anti-inflammatory would be preferable, say researchers from the University of Cadiz, Spain. They are trying to discern the molecular effects in case the therapeutic effect can be replicated less invasively. In May 2013, the team published findings in Molecular Psychiatry, "Early responses to deep brain stimulation in depression are modulated by anti-inflammatory drugs". (Medical News Today)
Feb. 18, 2014 - The importance of quickly processing and acting upon information during military conflicts is prompting military funding of research into transcranial direct current stimulation as a potential way to enhance cognitive alertness, according to an article and accompanying graphic in the Boston Globe. The New York Daily News said the soldiers in the tests were kept awake for 30 hours and reviewed digital surveillance or footage from drones. The volunteers in the five tests at Air Force Research Laboratory at Wright-Patterson Air Force Base in Ohio reportedly performed twice as well with active stimulation. (Boston Globe)
Feb. 18, 2014 - A power-efficient wireless transceiver circuit for use in body area networks for medical applications that adheres to the 400MHz-band international standard has been developed by Fujitsu Laboratories Ltd. and imec Holst Centre. Rather than require more than 12 milliwatts to monitor brainwaves or other vital signs as typically is needed, the circuit power requirements are reduced by more than a factor of 10 to 1.6mW for receiving data and 1.8mW for transmitting. (Today's Medical Developments)
Feb. 14, 2014 - In a review, the current evidence for peripheral neurostimulation is summarized for treatment of chronic migraine, trigeminal autonomic cephalagias and occipital neuralgia, and other secondary headache disorders. (Headache - The Journal of Head and Face Pain)
Feb. 13, 2014 - Neuroelectrics, a Spanish spinoff of Starlab Neuroscience Research, has opened its first U.S. office, which is based at the Cambridge Innovation Center in Massachusetts, where it will be near research laboratories that may use its non-invasive brain stimulation research products, a transcranial direct current stimulation device, Starstim, and a wireless EEG brain monitoring device, Enobio. (BioFlash)
Feb. 17, 2014 - Brainsway Ltd. announced it has installed deep transcranial magnetic stimulation systems at Karolinska University Hospital for depression treatment. The Swedish health system is public, the company noted, enabling more access to this mode of treatment than in the U.S. (Globes)
February 2014 - The International Annual BCI Award submission deadline is July 1, 2014; the award -- $3,000 -- recognizes outstanding, innovative research in brain-computer interfaces and has been supported since 2010 by the Australian BCI equipment supplier g.tec. (g.tec medical engineering GmbH)
February 2014 - Up to two years of funding for neuromodulation research into Parkinson's disease to relieve motor symptoms is offered by the Michael J. Fox Foundation for Parkinson's Research. Pre-proposals are due March 19. Ideal proposals involve clinical research or late-stage preclinical research in non-primates. The call for proposals calls deep brain stimulation a viable therapeutic option that provides benefit at low risk in appropriate patients although noting that the varying efficacy and side effects among subjects limits its full potential. (Michael J. Fox Foundation for Parkinson's Research)
Feb. 13, 2014 - An overview of new treatments for depression in Current Psychiatry mentions neuromodulation approaches and discusses theories about differences in neuron density; feedback pathways, and the role of stress in inflammatory response and cell turnover. (Medical Xpress)
Feb. 6, 2014 - Surgeons from the Neurogastroenterology Unit at Aarhus University in Denmark report that in a randomized, controlled crossover study of sacral nerve stimulation (SNS) for irritable bowel syndrome (IBS), IBS-specific symptoms were significantly reduced during stimulation in the 21 participants, and conclude that SNS improves quality of life for highly selected IBS patients. The study subjects had a minimum baseline IBS symptom score of 40 points, reduced at least 30% during a percutaneous nerve evaluation prior to implantation. At one-year follow-up, the median IBS symptom sore had dropped from 62 to 25. (Annals of Surgery)
Feb. 11, 2014 - International Neuromodulation Society member Richard North, MD and co-authors report a retrospective series of patients in which percutaneous lead anchors were secured with a small amount of adhesive in 291 patients from 1998 to 2006. When one case of migration was observed involving a short anchor, from 2007 to 2013, in 142 consecutive patients, only a long anchor was used and a fascial incision was added to accommodate its tip, as well as stronger suture material. With a mean follow-up of 2.86 years, no migration was observed in the second set of patients; in the first series, over a mean follow-up of 4.75 years, 1.37% (4) patients experienced lead migration requiring revision. (Neuromodulation: Technology at the Neural Interface)
Feb. 11, 2014 - The CEO of Autonomic Technologies, Inc. and a patent attorney write in an opinion piece that proposed anti-patent-infringement legislation is unnecessarily too broad and could harm companies that assemble goods with components sourced from many manufacturers. The article describes the benefits of the startup company's ATI Neurostimulation System, a small implant designed to halt headache. (San Jose Mercury News)
Feb. 11, 2014 - A column in the Wall Street Journal looks at research at Oxford University into whether noninvasive transcranial electrical stimulation can help improve performance in math. (Wall Street Journal)
Feb. 11, 2014 - Biomarkers are needed to screen for patients who would be most likely to respond to deep brain stimulation (DBS) for depression, according to Helen Mayberg, MD, who spoke to the Royal College of Surgeons of Ireland. Mayberg said the treatment relieves psychic suffering so patients can be re-trained to engage in life in ways they are unused to, and that their previous therapeutic interventions continue. She said about 200 people have received DBS and about 80% of those in a clinical trial based in Atlanta have a sustained response, and 63% in a clinical trial based in Toronto have a sustained response. She also discussed her collaborations on brain imaging before and after cognitive behavioral therapy, which impacts the frontal cortex primarily, while drugs primarily impact the brain stem and limbic system. (Irish Times)
Feb. 9, 2014 - International Neuromodulation Society member Esmiralda Henderson, MD's first patient where she established a deep brain stimulation (DBS) service at Mercy Medical Center in Des Moines -- Iowa's second DBS center -- was videotaped showing how much the stimulation calms his essential tremor symptoms. The news coverage included a description of the therapy. (Des Moines Register)
Feb. 7, 2014 - A retrospective study in the Journal of Trauma and Acute Care Surgery of 22 spinal cord-injury patients who had received neurostimulation to aid breathing through diaphragm pacing just 40 days after injury found that 72% were able to breathe independently without a respirator after an average of 10 days. All the others had delayed or partial weaning but one who was taken off life-prolonging support after entering long-term acute care. Eight patients completely recovered the ability to breathe and the neurostimulation wires were removed. The study looked at 29 patients, seven of whom not did receive an implant because laparoscopic diaphragm mapping to electronically read diaphragm nerves showed their phrenic nerves were not intact. The Diaphragm Pacing System by Synapse Biomedical, Inc., NeuRx, has FDA humanitarian device approval for spinal cord injury patients and patients with amyotrophic lateral sclerosis. It received Health Canada approval in November 2013 for patients with ventilator-dependent spinal injury, and CE Mark approval in 2007 for diaphragm dysfunction. (Medical Express)
Feb. 6, 2014 - A 32% growth in neuromodulation in the last three months of 2013 for Boston Scientific Corporation and a 6% growth in Medtronic Inc.'s most recent quarter were mentioned in a column that asks if the medical device industry is the biggest player in health care. (Motley Fool)
Feb. 6, 2014 - Independence Blue Cross of southeastern Pennsylvania will cover percutaneous tibial nerve stimulation for treatment of overactive bladder, device maker Uroplasty, Inc. announced. The addition of 2.2 million people covered by the carrier brings to some 150 million people who are covered by private insurance or Medicare who now have access to the therapy. (Wall Street Journal)
Feb. 5, 2014 - Depression is called the likely biggest incremental driver for value of shares of Cyberonics, Inc., whose vagus nerve stimulation systems are FDA-approved for treatment of epilepsy and depression. (Seeking Alpha)
Feb. 5, 2014 - International Neuromodulation Society member Brian Kopell, MD was interviewed regarding a patient whose more extreme tics caused by Tourette syndrome were quieted instantly when his deep brain stimulation system was programmed in September 2013. The patient's tics had included stumbling, punching himself in the head, and uttering profanities. A news report focused on the fact that the patient and his wife can finally go for walks while holding hands. (Good Morning America)
Feb. 2, 2014 - An analysis of randomized controlled trials comprising almost 1,200 patients up to April 2013 indicates that deep brain stimulation for Parkinson's disease "significantly improves patients’ symptoms, functionality and quality of life," a research team writes in The Journal of Neurology. They add that although the number of studies included (6) is small, the relatively large sample size does confirm treatment efficacy. (Journal of Neurology)
Dec. 19, 2013 - A psychiatrist who teaches bioethics at Columbia University presents emerging clinical experience involving deep brain stimulation in addiction and other behavioral conditions. (Scientific American)
Feb. 4, 2014 - In consultation with the Australian Department of Health's Therapeutic Goods Administraton, Medtronic Australasia has issued a hazard alert and recall for product correction concerning deep brain stimulation (DBS) and spinal cord stimulation (SCS) models that may pose a potential for loss of stimulation or over-stimulation or stimulation in the wrong area under certain conditions: DBS models Activa PC, Activa RC and Activa SC models 37601, 37602, 37603, 37612 (Activa SC models 37602 and 37603 are not affected by the over-stimulation or stimulation in the wrong area issue); and SCS RestoreUltra and RestoreSensor models 37712, 37714. Avoiding over-discharge is advised for reducing the likelihood of over-stimulation or stimulation in the wrong area -- patients should call 1800 688 670 if their device is over-discharged. At the next visit a software upgrade to the clinician's programmer will correct the potential loss of stimulation issue. (Australian Therapeutic Goods Administration)
Feb. 4, 2014 - Boston Scientific Corporation's fourth quarter results for the three months ending Dec. 31, 2013 showed a 33% increase in the neuromodulation sector of its medical-surgerical division -- the second quarter in a row that neuromodulation revenue topped 30% -- and overall 5% operational revenue growth and 1% revenue growth on a reported basis compared to the prior year period. (Yahoo! Finance)
Feb. 4, 2014 - Los Gatos, Calif.-based CIRTEC Medical Systems has released a development platform for neuromodulation devices, VeraSTIM, that offers 4 channels, 32 electrodes, up to 10,000 HZ frequency, remote transcutaneous charging, and multiple pulse modes (burst, ramp up, ramp down, etc.). The flexibility enables testing multiple parameters during device development. (PR Newswire)
Feb. 4, 2014 - A researcher says her optogenetics work in rats might be used to understand and possibly treat other conditions by using similar viral vectors to infuse therapeutic genes into relevant brain regions. In her research, rats sought alcohol less after low-frequency, prolonged stimulation of dopamine neurons in the ventral tegmental area led to accumulation of dopamine in the nucleus accumbens, which had been thought to play a role in regulating alcohol consumption. Conversely, inducing phasic release of dopamine with brief high-frequency stimulation did not lead to less drinking of alcohol by the rats. (State University of New York at Buffalo)
Feb. 3, 2014 - A research team that took extracellular single-unit recordings in the pedunculopontine nucleus of 10 Parkinson's disease patients during "awake" surgery for implantation of deep brain stimulators writes in Nature Neuroscience that different synchronous networks were activated during initial motor planning and actual motion, suggesting that changes in gait initiation in Parkinson's disease may result from disrupted network activity. (HealthCanal)
December 2013 - The BROADEN (BROdmann Area 25 DEep brain Neuromodulation) Study has been closed, reportedly after a futility analysis did not support continuing St. Jude Medical's clinical investigation of the intervention in treatment-resistant major depressive disorder, following an FDA-approved expansion in 2011 of up to 20 sites and 231 patients. (Neurotech Business Report) (Neurotech Reports)
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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Clinical trials that involve a wide range of emerging neuromodulation approaches are listed on our Resources and Research pages. Neuromodulator trials address symptom control through nerve stimulation in such condition categories as:
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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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