Soterix Medical Inc. awarded $2.5M NIH grant to run Phase-2 Efficacy Trial to treat Aphasia after Stroke with HD-tDCS
Soterix Medical, Inc. (SMI), the leading non-invasive neuromodulation medical technology company, announces the award of a $2.5 million grant from the National Institute of Neurological Disorders and Stroke to support a Phase-2 Clinical Trial aimed at establishing the effectiveness of individualized High-Definition transcranial Direct Current Stimulation (HD-tDCS™) for adjunctive treatment of anomia in chronic post-stroke aphasia. The multi-center, randomized, sham-controlled, double-blind trial includes collaborators from Georgetown University, University of North Carolina, Medstar Research Institute, The City College of New York (CCNY) and University of South Carolina.
Additional trial information can be found here.
Aphasia is an impairment of language, affecting production or comprehension of speech and the ability to read or write. It is a debilitating long-term consequence for 1 in 5 stroke cases. For these patients, HD-tDCS, combined with speech therapy, has the potential to improve language function. HD-tDCS delivers current to an individually targeted brain region to enhance plasticity during speech therapy and thus improve functional outcomes. Individualized targeting is particularly important in stroke rehabilitation where the presence of brain lesions leads to drastically altered stimulation pattern. Based on each patient brain scan (MRI), therapy can be targeted by clinicians to specific viable brain areas determined with functional MRI, making HD-tDCS, the first non-invasive individualized neuromodulation technique.
The Phase-2 Clinical Trial follows a successful Phase-1 Clinical Trial that demonstrated that Soterix Medical’s exclusive Neurotargeting™ software could be used to individualize therapy to each patient, with the goal to boost plasticity in the targeted brain regions. The hardware system uses patent protected "HD" electrode arrays.
Dr. Abhishek Datta, Scientist and CTO of SMI and Dr. Lucas C. Parra, Professor of Biomedical Engineering at CCNY will lead the study as Principal Investigators.
"This grant from the National Institute of Health will advance the validation of HD- tDCS as the only neuromodulation platform that is non-invasive, low-intensity, and targeted. Soterix Medical is the technology leader in non-invasive neuromodulation with a commitment to enhance the treatment of neuropsychiatric disorders and neuro-rehabilitation after injury. This trial supports our mission to translate medical research in neuromodulation to clinical practice." said Dr. Datta. "I am very pleased that NIH has funded this extremely important Phase-2 trial. The full development of this electrical stimulation platform and the safety outcomes have potentially broader clinical applicability included motor recovery in stroke and analgesic effects in central pain" said Dr. Parra.
CAUTION: Investigational device. Federal (or United States) law limits device to investigational use.
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.
See full press release here