Soterix Medical Inc. announces today a new clinical trial for Chronic Pain (Fibromyalgia)
Soterix Medical Inc. announces today a Phase-1 trial for Chronic Pain and Fibromyalgia at Harvard Medical School and Spaulding Rehabilitation Hospital. The trial will be headed by Dr. Felipe Fregni, one of the foremost international neuromodulation specialists worldwide with the support of the Wallace H. Coulter Foundation and in collaboration with The City College of New York of CUNY.
Dr. Abhishek Datta, CTO of Soterix Medical states “Soterix Medical is excited that High-Definition tDCS will be evaluated for efficacy in chronic pain at the one of the best clinical trial centers for neuromodulation. There is tremendous interest in the application of neuromodulation for chronic pain disorders but only HD-tDCS allows safe and targeted delivery of DC current to targeted brain structures. As a result we expect both increased efficacy and limited side-effects. This study will use our proprietary HD-electrodes which allow safe and well tolerated stimulation.”
From ClinicalTrials.Gov “The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation. The study will determine whether anodal or cathodal HD-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the HD-tDCS stimulation sessions and after the HD-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.
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