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Testing High-Definition Transcranial Direct Current Stimulation for Fibromyalgia

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www.ProHealth.com • February 28, 2013

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News Release:

Soterix Medical Inc. reports positive results from High-Definition tDCS Fibromyalgia Trial at Harvard Medical School
– Source: PRNewswire, February 20, 2013

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 [resistant] 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 [resistant] 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.

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.

1http://www.sciencedirect.com/science/article/pii/S1526590012009674
2http://www.ncbi.nlm.nih.gov/pubmed/23130002

Abstract:

Focal Modulation of the Primary Motor Cortex in Fibromyalgia Using 4×1-Ring High-Definition Transcranial Direct Current Stimulation (HD-tDCS): Immediate and Delayed Analgesic Effects of Cathodal and Anodal Stimulation.
– Source: Journal of Pain, February 14, 2013

By Mauricio F. Villamar, et al.

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. Given previous evidence supporting analgesic properties of noninvasive brain stimulation techniques in this condition, this study examined the effects of a novel, more focal method of transcranial direct current stimulation (tDCS), using the 4×1-ring configuration of high-definition (HD)-tDCS, on overall perceived pain in fibromyalgia patients.

In this patient- and assessor-blind, sham-controlled, crossover trial, 18 patients were randomized to undergo single 20-minute sessions of anodal, cathodal, and sham HD-tDCS at 2.0 mA in a counterbalanced fashion. The center electrode was positioned over the left primary motor cortex. Pain scales and sensory testing were assessed before and after each intervention. A finite element method brain model was generated to predict electric field distribution.

We found that both active stimulation conditions led to significant reduction in overall perceived pain as compared to sham. This effect occurred immediately after cathodal HD-tDCS and was evident for both anodal and cathodal HD-tDCS 30 minutes after stimulation. Furthermore, active anodal stimulation induced a significant bilateral increase in mechanical detection thresholds. These interventions proved well tolerated in our patient population.

PERSPECTIVE: 4×1-ring HD-tDCS, a novel noninvasive brain stimulation technique capable of more focal and targeted stimulation, provides significant reduction in overall perceived pain in fibromyalgia patients as compared to sham stimulation, irrespective of current polarity. This technique may have other applications in research and clinical settings, which should be further explored.


Source: Journal of Pain, February 14, 2013. By Mauricio F. Villamar, Pakorn  Wivatvongvana, Jayanton  Patumanond, Marom  Bikson, Dennis Q.  Truong, Abhishek  Datta, Felipe  Fregn. Laboratory of Neuromodulation, Department of Physical Medicine & Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; School of Medicine, Pontifical Catholic University of Ecuador, Quito, Ecuador.



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