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NeuroSigma Announces Presentation of Clinical Trial Data Showing Increased Brain Activity and Improved Cognition in Children with ADHD Treated with eTNS
LOS ANGELES, June 27, 2019 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders announces the presentation of new clinical trial data showing statistically significant changes in brain activity on EEG and improved cognition in children with ADHD treated with external Trigeminal Nerve Stimulation (eTNS®). The data will be presented today, June 27, 2019, by Sandra Loo, Ph.D., Professor of Psychiatry at the UCLA Semel Institute for Neuroscience and Human Behavior, at the International Society for Research in Child and Adolescent Psychopathology meeting held in Los Angeles, California. The research was conducted as part of the pivotal trial of eTNS for pediatric ADHD that supported FDA clearance of the Monarch eTNS System.
Dr. Loo's presentation entitled, Trigeminal Nerve Stimulation for ADHD: Predictors of Response, concluded that children successfully treated with eTNS had increased brain activity on EEG as well as significant improvements in certain aspects of cognition as compared to non-responders.
"Our work with eTNS suggests that successful treatment response to eTNS appears to address a number of cognitive and neural deficits typically associated with ADHD," said Dr. Loo. "Additional investigations of this new treatment modality are warranted to better understand these effects, to predict which children may benefit prior to initiating treatment, and to provide independent replication in larger samples of children with ADHD," added Loo.
"Dr. Loo and her colleagues have done outstanding work in advancing our understanding of the eTNS mechanism of action," said Ian Cook, M.D., NeuroSigma's Chief Medical Officer. "The EEG findings are an objective biomarker that demonstrates a significant effect from 4-weeks of nightly eTNS in this patient population. We look forward to continued investigations of these effects as we advance our eTNS portfolio," added Cook.
Background – eTNS
For more information on eTNS, please visit the Monarch eTNS website.
NeuroSigma's Monarch eTNS System is indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep. The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events have been associated with use of the device.
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) 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 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 disorders, including ADHD. 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
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SOURCE NeuroSigma, Inc.