Published 16 October 2014 NeuroSigma a California-based life sciences company focused on commercialization of its non-invasive Monarch eTNS System for the treatment of neurological and neuropsychiatric disorders, has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Veterans Affairs (VA) for a clinical trial to evaluate the benefits of non-invasive, external Trigeminal Nerve Stimulation (eTNS) for patients with traumatic brain injury (TBI) in a Phase I clinical trial. Jean-Philippe Langevin, M.D., an expert in neurotrauma and a neurosurgeon at the Veterans Affairs Greater Los Angeles (VAGLA) medical center, will lead the study as Principal Investigator. The project will enroll U.S. military veterans with TBI in an eight-week treatment protocol, and will examine change in cognitive function and regional brain activity as people receive nightly eTNS treatment at home. TBI is a condition that arises after mechanical injury to the brain. According to the Centers for Disease Control and Prevention, an estimated 5.3 million Americans currently live with TBI-related disability, with an annual total cost in 2010 estimated at $76.5 billion, including $11.5 billion in direct medical costs and $64.8 billion in indirect costs including lost wages, lost productivity, and nonmedical expenditures. The Department of Defense has reported … Continue reading
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