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Positive Results Reported for Phase I Clinical Trial at UCLA for the Treatment of ADHD in Children Using External Trigeminal Nerve Stimulation (eTNS)
Date:5/20/2013

LOS ANGELES, May 20, 2013 /PRNewswire/ -- Today, at the American Psychiatric Association (APA) Meeting in San Francisco, James McGough , M.D., M.S., principal investigator and Professor of Clinical Psychiatry at the Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at the University of California Los Angeles (UCLA), and director of clinical teaching programs in both Child and Adolescent Psychopharmacology and ADHD at UCLA, presented the results of a Phase I open-label pediatric clinical trial. The study commenced in November 2011 and investigated the effects of external Trigeminal Nerve Stimulation (eTNS™) on Attention Deficit Hyperactivity Disorder (ADHD) as stand-alone monotherapy (i.e., without use of medications of any kind).

Mean improvements of over 40% were recorded after 4 weeks and over 45% after 8 weeks (both results p<0.001 versus baseline) using the total scores of the a priori primary outcome metric, the clinician-rated ADHD Rating Scale (ADHD-RS). These results are in line with improvements reported in other clinical trials that used stimulant medications, and form the basis for proceeding with larger clinical trials under double blind conditions to better establish its effects.  In the eTNS trial, 20 subjects, aged 7 to 14 years with APA Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of ADHD, had stimulating electric patch electrodes placed on their foreheads on a nightly basis while asleep.  Their ADHD symptoms were assessed every four weeks.  eTNS was well tolerated and no serious adverse events occurred during the 8-week treatment period.

The investigator-initiated study was funded entirely by NeuroSigma and conducted at UCLA.  Project design, data collection, analyses, and conclusions, were solely the work of the UCLA study investigator
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