Soterix Medical Inc., announces the launch of a Phase-2 clinical trial that will evaluate the combination of REMOTE-tDCS and a brain training program for the treatment of long COVID.The trial will be administered through NYU Langone Health's home-based remotely supervised (RS) tDCS program, which includes a clinical service that is available to patients across the United States.
Led by the National Institutes of Health (NIH), the Researching COVID to Enhance Recovery (RECOVER) Initiative was created to address the widespread and diverse impacts of long COVID. The specific study called RECOVER-NEURO will examine accessible interventions for cognitive dysfunction related to long COVID, including brain fog, memory problems and difficulty with attention, thinking clearly and problem solving. Interventions under this protocol include digital cognitive training program by Posit Science, the PASC-Cognitive Recovery, a web-based goal management training program, developed by Mount Sinai Health System, and the home-based transcranial direct current stimulation (tDCS) system designed by Soterix Medical for use in RS-tDCS. RECOVER-NEURO is expected to test a group of up to 315 participants.
Dr. Abhishek Datta, CEO of Soterix Medical commented that, "The Soterix Medical REMOTE-tDCS platform is the most validated hardware and software system for home-based tDCS. REMOTE-tDCS combines unique accessories, tDCS-LTE hardware, and telemedicine which can be customized for each clinical indication. NIH RECOVER-NEURO develops a Long COVID treatment based on digital therapy and Soterix Medical's REMOTE-tDCS platform."
"It's a great advance to see incorporation of tDCS treatment arms in the RECOVER initiative," said Dr. Leigh Charvet, PhD, professor in the Department of Neurology and director of the tDCS program at NYU Langone. "This trial was informed by previous findings that the combination of tDCS and online cognitive training can assist in recovery from long COVID, including improved cognitive function."
Mr. Kamran Nazim, Chief Product Officer of Soterix Medical adds, "Soterix Medical tDCS-LTE platforms have been shown in prior studies to improve cognition in healthy adults, and have shown promise in a variety of clinical conditions, including many conditions associated with cognitive or attention impairment or brain fog. Basic science studies have shown a dual action of tDCS-LTE deriving from both boosting brain plasticity and enhancing brain blood flow. This provides a strong rationale for testing tDCS-LTE for Long COVID."
More information about RECOVER-NEURO can be found at: https://trials.recovercovid.org.
CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.
See full press release here.
BACKGROUND:
tDCS-LTE by Soterix Medical is the only technology optimized for robust deployment in a wide variety of environments including emergency medicine, field-work, home-use, etc.
Media Contact: Chaya Edelman
Tel: +1-888-990-8327
Email: contact@soterixmedical.com
