NeuroSigma Systems today released preliminary data from a trial of its Monarch trigeminal nerve stimulation system designed to treat combat veterans with traumatic brain injuries, citing improvements in memory, anxiety and brain activity.
The results were presented at the North American Neuromodulation Society’s meeting in Las Vegas, the company said.
The trial was performed at the Veterans Affairs West Los Angeles Medical Center, and results showed improvements in symptoms of TBI and desired changes in brain activity, according to the company.
“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. 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. We look forward to continued positive results and completion of this Phase I trial,” chief medical officer Dr. Ian Cook said in a press release.
The Monarch eTNS system is composed of a small pulse-generator and single-use electric patch applied to the forehead, with signals transmitted through lead wires into the patch to stimulate the trigeminal nerve, NeuroSigma said.
In November, NeuroSigma said it won CE Mark approval in the European Union for its Monarch eTNS system indicated to treat attention-deficit/hyperactivity disorder in adults and children 7 and older.
Los Angeles-based NeuroSigma said it is the 1st and only non-drug treatment for ADHD approved in the European Union.