NEW YORK, Feb. 20, 2013 /PRNewswire/ -- Soterix Medical, Inc. is pleased to report positive results of a double-blind, sham-controlled, crossover trial of 18 patients with Fibromyalgia conducted at Harvard Medical School1. Fibromyalgia is a prevalent chronic pain syndrome characterized by altered pain and sensory processing in the central nervous system, which is often refractory to multiple therapeutic approaches. The Harvard clinical trial examined the effects of the Soterix Medical's exclusive 4x1 High Definition - Transcranial Direct Current Stimulation (HD-tDCS) on overall perceived pain in patients. HD-tDCS proved well tolerated and produced a significant reduction in overall perceived pain in Fibromyalgia patients as compared to sham stimulation.
"We are thrilled at these positive results in Fibromyalgia," said Dr. Abhishek Datta, CTO of Soterix Medical, "Patients with Fibromyalgia are often refractory to pharmacological intervention and experience side-effects, so the ability of just one session of HD-tDCS to reduce pain without side-effects is striking. The effects observed in a single session were larger than with either conventional tDCS or FDA approved Transcranial Magnetic Stimulation (TMS). We expect that with repeated HD-tDCS, both the magnitude and durability of effects will increase and this is precisely the objective of our enhanced HD-tDCS Fibromyalgia multi-center trial – which is now recruiting, including at Harvard Medical School. These results are only possible with the proprietary Soterix Medical HD-tDCS where unique electrode and specialized arrays provide non-invasive targeted Neuromodulation not possible with any other technique. Soterix Medical will continue to pioneer HD-tDCS and its investigation in Fibromyalgia and other pain syndromes."
These results follow mechanistic findings at University of Michigan - tDCS using the Soterix Medical 1x1 promotes release of endogenous opioids providing a mechanistic substrate for the treatment of pain disorders and Migraine2.
CAUTION: tDCS and HD-tDCS are limited by Federal (or United States) law to investigational use only.
BACKGROUND: High-Definition tDCS (HD-tDCS) is an exclusive Neuromodulation technology developed by Soterix Medical Inc. Invented at The City College of New York, it is the only technology platform that allows tolerated non-invasive delivery of therapeutic current to desired brain regions. As a result, HD-tDCS offers potential for safe and effective treatment of neuropsychiatric disorders not possible with any other technology. HD-tDCS is made possible through innovations in electrode design allowing safe and tolerated passage of current through proprietary "High-Definition" electrodes, individualized brain current-flow modeling and through patented targeting algorithms indicating how to place and energize HD-electrodes on the head.
Fibromyalgia (FM or FMS) is a medical disorder characterized by chronic widespread pain and allodynia (a heightened and painful response to pressure). Fibromyalgia is one of the most common chronic pain conditions. The disorder affects an estimated 10 million people in the U.S. and an estimated 3-6% of the world population. It is most prevalent in women —75-90% of people who have FM are women. Fibromyalgia symptoms are not restricted to pain, leading to the use of the alternative term Fibromyalgia Syndrome for the condition. Other symptoms include debilitating fatigue, sleep disturbance, and joint stiffness. Some patients also report cognitive dysfunction.
Soterix Medical Inc. is a Biomedical Engineering company based in New York City committed to developing innovative medical therapies. Soterix Medical is the leader in non-invasive electrical Neuromodulation including the exclusive High-Definition tDCS. Soterix Medical Inc. supports clinical trials aimed at treatment of neuropsychiatric disorders. Soterix Medical's patented Limited Total Energy (LTE-tDCS) is the only Neuromodulation technology optimized for susceptible populations. The Soterix Medical Clinical Trials (CT-tDCS) is being used in multi-center clinical trials internationally.
SOURCE Soterix Medical, Inc.