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.
(Photo: http://photos.prnewswire.com/prnh/20110705/NY29679
)
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
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