Soterix Medical,Inc. announced today the completion of its Phase-1 Stroke-Aphasia trial using its revolutionary and proprietary non-invasive brain targeting platform called High Definition-Transcranial Direct Current Stimulation HD-tDCS.
Stroke is the fourth leading cause of death in the U.S. affecting 800,000 every year.
“We are proud to complete our Phase-1 trial. This is a major milestone for Soterix Medical and enhances our efforts to transform the way Stroke rehabilitation is managed. I wish to thank National Institute of Health for funding this study, the partnering clinical site of University of South Carolina and recognize each and every patient in our clinical trial” said Dr. Abhishek Datta, Chief Technology Officer, Co-Founder of Soterix Medical, and Co-Inventor of HD-tDCS. “We are thrilled to see the fruition of our vision of using small electrode arrays to deliver targeted stimulation to desired brain targets. Our patented approach allows individualized tDCS therapy and initial studies indicate more tolerable stimulation than conventional-tDCS using sponges”.
Soterix Medical has secured FDA-Investigational Device Exemption (IDE) in anticipation of a muti-site Phase-2 trial.
In a recent landmark study from the group that introduced tDCS in its current form, Dr. Michael Nitsche and Dr. Walter Paulus found that HD-tDCS produced larger and longer-lasting brain excitability changes than conventional-tDCS.
Background:HD-tDCS platform HD-tDCS was invented after years of compelling modeling evidence and comprehensive animal/ pre-clinical studies conducted at City University of New York (CUNY). Dr. Abhishek Datta spearheaded the modeling approach as part of his doctoral study at the CUNY laboratory of Dr. Marom Bikson and Dr. Lucas C. Parra. HD-tDCS was developed to combine the benefits of tDCS, namely low-intensity currents, safety profile, and neuromodulation plasticity with targeting control matching Transcranial Magnetic Stimulation - an FDA approved therapy. The HD-tDCS platform comprises either the basic 4-channel Adapter (4x1) or the advanced 8-channel Stimulator (MxN). HD-tDCS dose (electrode placement and individual electrode currents) is determined using individualized brain current-flow modeling in combination with the Neurotargeting Softwares: HDTargets and HDExplore.
HD-tDCS,1x1,4x1,MxN, HDTargets, HDExplore are trademarks of Soterix Medical Inc
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