LOS ANGELES, July 5, 2011 /PRNewswire/ -- NeuroSigma, a Los Angeles-based neuromodulation company, today announced that a recent Phase I clinical trial revealed that external Trigeminal Nerve Stimulation (eTNS™) increased regional cerebral blood flow in brain regions associated with depression and mood regulation. eTNS™ was shown to be a potential therapy for depression, with significant reductions in depression severity during the 8-week adjunctive treatment period. These encouraging results have led to a Phase II double-blind trial with expected completion later this year.
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eTNS™ and Depression
Trigeminal Nerve Stimulation (TNS) is a promising new therapy for the treatment of major depression without the typical side effects of antidepressants. TNS was invented by researchers at UCLA and is exclusively licensed to NeuroSigma.
In June of last year, UCLA investigators reported preliminary results from the first five patients of the open-label Phase I TNS feasibility trial, noting a 70% reduction in symptom severity over the 8-week acute phase of treatment, resulting in an 80% remission rate. ( http://newsroom.ucla.edu/portal/ucla/non-invasive-therapy-significantly-169741.aspx ).
Last month, at the New Clinical Drug Evaluation Unit (NDCEU) 51st Annual Meeting in Boca Raton, Florida, Ian Cook, M.D., the Joanne and George Miller Family Chair in Depression Research at the Semel Institute at UCLA, and a medical advisor to NeuroSigma, presented additional data from four new subjects enrolled in this Phase I trial, which included functional neuroimaging PET data. Cook noted that "with just brief exposure to eTNS™, significant increases in regional cer