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 these 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
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 attention-deficit hyperactivity disorder (ADHD), drug resistant epilepsy, major depression, and other disorders.
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.
About NeuroSigma, Inc.
NeuroSigma is a California-based life sciences company established to develop bioelectronic technologies with the potential to transform medical practice and patients' lives. NeuroSigma is focused on TNS neuromodulation therapies based on intellectual property, licensed on an exclusive basis from the University of California, Los Angeles (UCLA), covering a wide-spectrum of neurological and neuropsychiatric disorders. For more information about NeuroSigma, please visit www.neurosigma.com.
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
SOURCE NeuroSigma, Inc.