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Interim Results Reported for Phase I Open-Label Clinical Trial for the Treatment of PTSD and MDD Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™
Date:5/30/2012

LOS ANGELES, May 30, 2012 /PRNewswire/ -- Today, at the 52nd annual New Clinical Drug Evaluation Unit (NCDEU) Conference in Arizona, Ian Cook, M.D., Professor of Psychiatry at the University of California, Los Angeles (UCLA) and a Senior Medical Advisor to NeuroSigma, Inc., presented the results from the first 6-subject cohort of a 10-subject Phase I open-label clinical trial studying the effects of external trigeminal nerve stimulation (eTNS™) on Post-Traumatic Stress Disorder (PTSD) and depressive symptoms in Major Depressive Disorder (MDD) as an adjunct to pharmacotherapy.  The trial is being conducted at UCLA and is funded by NeuroSigma.  Mean decreases in PTSD measures of 36% and depression measures of over 50% were reported.

The study was conducted over an 8-week period and followed similarly designed eTNS trials conducted at UCLA, in which promising results were generated in treating both major depression and epilepsy.  Subjects had a mean age of 54 with a median of 28 years since traumatic exposure and suffered from both PTSD and MDD.  Current episodes were required to be of at least four months in duration, with non-response to at least one antidepressant.  In this outpatient trial, subjects placed stimulating eTNS electrodes on their foreheads for approximately eight hours each night while asleep, and the severity of PTSD and depression symptoms was measured every two weeks using standard recognized rating scales. 

"These findings are very encouraging," said Dr. Cook.  "The combination of depression and an anxiety disorder, like PTSD, is usually difficult to treat effectively.  The participants in the study told us that eTNS was easy to use at home and led, in some instances, to the best mental health they had experienced in years.  We expect these results, along with results from the remaining subjects in this Phase I trial, to form the basis for an upcoming Phase II clinical trial
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