NeuroSigma Congratulates Spanish Team for their Results in Randomized Controlled Trial of eTNS in Drug Resistant Epilepsy
LOS ANGELES, June 24, 2020 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders today announced that results from a randomized controlled trial of external Trigeminal Nerve Stimulation (eTNS®) for treating drug resistant epilepsy (DRE) were published in the June 2020 issue of the journal Brain Stimulation.
The trial, conducted at the Hospital Clinic de Barcelona, in Barcelona, Spain, randomized forty subjects with frontal or temporal DRE who were not candidates for surgery to receive either eTNS or their usual medical treatment. Subjects were evaluated at 3, 6, and 12 months for reductions in seizure frequency, side effects and quality of life. At the 6 and 12-month timepoints, there was a 50% responder rate in subjects receiving eTNS versus a 0% responder rate among subjects randomized to the control group (p < 0.001). Similarly, after 12 months there was a median reduction in seizure frequency of 43.5% in the eTNS group versus 0% in the control group (p = 0.0013). There were no significant adverse events associated with use of eTNS and the treatment was well tolerated for the duration of the trial. The trial was funded by the Sanitary Research Fund of the Carlos III Institute of Health (Spain) and conducted with Monarch eTNS Systems® purchased from NeuroSigma.
"We are very pleased to report these results from our trial, which was conducted completely independent from NeuroSigma," said Mar Carreño, M.D., principal investigator of the trial, Director of the Epilepsy Unit at the University of Barcelona Hospital, and President of the Spanish Epilepsy Society. "Treatment was well tolerated by patients randomized to receive eTNS, and we observed significant improvements in seizure frequency over time. Based on thee findings, we believe that eTNS is an interesting new option for patients with drug resistant epilepsy," added Carreño.
"We would like to congratulate Dr. Carreño and her team for completing this important clinical trial of eTNS as an adjunctive therapy for patients with DRE," said Ian Cook, M.D., Chief Medical Officer of NeuroSigma. "These findings validate NeuroSigma's strategy to develop eTNS as a platform technology for neurological and neuropsychiatric conditions," said Colin Kealey, M.D., NeuroSigma's VP of Advanced Development and Medical Affairs.
NeuroSigma's Monarch eTNS System received marketing clearance from FDA in 2019 as a treatment for pediatric ADHD in children ages 7-12. In the European Union, the Monarch eTNS System is approved as adjunctive therapy for drug resistant epilepsy and major depressive disorder, as well as monotherapy for ADHD, all in patients 7 years and older.
Background – TNS
Trigeminal Nerve Stimulation (TNS) is mild 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.
eTNS, Monarch, and Monarch eTNS System are trademarks of NeuroSigma, Inc.
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