LOS ANGELES, Dec. 10, 2015 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), today announced positive preliminary findings from a clinical study using non-invasive external Trigeminal Nerve Stimulation with the Monarch eTNS System® to treat combat veterans. Results were presented at the North American Neuromodulation Society (NANS) meeting in Las Vegas and mark the first report of using eTNS® in patients with Traumatic Brain Injury (TBI).
The clinical trial was performed at the Veterans Affairs West Los Angeles (VAWLA) Medical Center and showed improvements in symptoms of TBI and desired changes in brain activity. Jean-Philippe Langevin, M.D., an expert in neurotrauma and a neurosurgeon at VAWLA, is the Principal Investigator utilizing the Monarch eTNS System to treat combat veterans in the study. TBI is a condition that can arise from mechanical injury to the brain.
"We are pleased by the preliminary results reported by Dr. Langevin and his colleagues. Neuroimaging data indicate that 8 weeks of nightly eTNS treatment can produce a lasting desired influence on the activity of specific brain areas that are linked to TBI, along with improvements in memory, anxiety, and other symptoms that are common in patients with TBI," said Ian A. Cook, M.D., NeuroSigma's Chief Medical Officer. "TBI not only affects many of our combat veterans, but may also result from motor vehicle accidents and sports-related injuries, as highlighted by recent attention to chronic traumatic encephalopathy, or CTE, among players from the National Football League (NFL). We look forward to continued positive results and completion of this Phase I trial," added Dr. Cook.
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. The Department of Defense has reported approximately 200,000 cases of TBI in troops between 2000 and June 2010. While many individuals recover fully, approximately 15 to 34 percent of individuals with mild or moderate TBI have persistent symptoms that may interfere with their return to work or school, including difficulties with memory, decision making, attention, movement, and emotional functioning. These issues not only impact the injured individuals, but can also have lasting effects on their families and communities.
The Monarch eTNS System is composed of a cell-phone sized pulse generator and a single-use electric patch that is applied to the forehead. Signals are transmitted through lead wires to the patch in order to stimulate the trigeminal nerve in the skin of the forehead; triggering these nerve fibers sends signals to targeted brain regions and changes the activity there. Patients may conveniently self-administer the Monarch eTNS system at home and typically use the device while sleeping.
About Trigeminal Nerve Stimulation
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. The trigeminal nerve projects directly or indirectly to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus, and the cerebral cortex, which are involved in epilepsy, depression, attention-deficit hyperactivity disorder (ADHD), post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and other disorders.
Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, including those located near the surface of the forehead. Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.
CAUTION: In the United States, the Monarch eTNS System is an investigational device and is limited by Federal law to investigational use.
eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a California-based life sciences company focused on commercialization of its non-invasive eTNS technology for the treatment of neurological and neuropsychiatric disorders, including epilepsy, depression, PTSD, ADHD, and TBI. The Monarch has received CE mark approval in the European Union as well as regulatory approvals in Canada and Australia.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS system. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.
Dr. Leon Ekchian, President & CEO
+1 (310) 479-3100
+1 (415) 202-5678
SOURCE NeuroSigma, Inc.