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Results Reported for Phase Ib Open-Label Clinical Trial for the Treatment of Depression Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™
Date:5/8/2012

LOS ANGELES, May 8, 2012 /PRNewswire/ -- Earlier today, at the American Psychiatric Association Annual Meeting in Philadelphia, Dr. Ian Cook, Principal Investigator and Professor of Psychiatry at UCLA, and a Senior Medical Advisor to NeuroSigma, Inc., presented the results of a Phase Ib open-label clinical trial that studied the effects of eTNS™ on depressive symptoms in Major Depressive Disorder (MDD) as an adjunct to pharmacotherapy.  Results from the 17-question Hamilton Depression Rating Scale (HDRS-17), a clinician-rated scale, showed a 50.0% reduction in depression and the Beck Depression Inventory (BDI), a self-reported scale, showed a 58.0% reduction in scores.  Both scales achieved statistical significance.  In the trial, subjects placed stimulating eTNS™ electrodes on their foreheads for 8 hours each night and their depression was measured every two weeks using recognized standard tests.  eTNS was well tolerated and no serious adverse events occurred during the 8-week treatment period.

The 11-subject study was conducted at the University of California, Los Angeles (UCLA).  A previous initial report of the first five subjects also found positive results.  "These findings confirm our preliminary observations that eTNS can impact symptoms in pharmacoresistant major depression.  The participants in the study told us that it was easy to use at home, and most noticed that they were feeling substantially better within the first two weeks, with even more improvement in the subsequent weeks.  As a result of these findings, a Phase II clinical trial, to test this potential adjunctive therapy under double-blind conditions, is being conducted at UCLA with funding provided by NeuroSigma.  I'm confident that the transfer of the technology from academia to industry will continue to proceed smoothly and hope this treatment will be made available to many patients in the near future," Dr. Cook said.


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