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Positive Results Reported for Phase II Randomized Double-Blind Clinical Trial for the Treatment of Drug-Resistant Epilepsy Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™
Date:4/28/2011

LOS ANGELES, April 28, 2011 /PRNewswire/ -- This afternoon, at the Antiepileptic Drug Trials XI Conference in Miami, Florida, (http://www.epilepsy.com/etp/aedtrialxi) Dr. Christopher DeGiorgio, principal investigator and neurologist at UCLA, presented the results of a Phase II randomized double-blind clinical trial for the treatment of refractory epilepsy.  The 50-subject study was conducted at UCLA and the University of Southern California.  "I'm excited to see that our non-invasive and very safe approach to neuromodulation demonstrates efficacy under double-blind controlled conditions and compares favorably with pharmaceutical and surgically-invasive approaches.  We look forward to proceeding to the next phase of the regulatory approval process and clinical development for our epilepsy therapies," DeGiorgio said.

This study was a randomized double-blind, active-controlled clinical trial of external TNS (eTNS™) therapy in 50 people with drug resistant epilepsy.  All subjects in the study were aged between 12 – 70 with a history of intractable seizures and exposure to at least two antiepileptic drugs at adequate doses.

The study was funded by investigator-initiated grants from the Epilepsy Therapy Project, the Epilepsy Foundation, Boston Scientific and the Milken Family Foundation.  The TNS technology, including eTNS™ for the treatment of epilepsy, was originally invented and developed at UCLA.

NeuroSigma, Inc., a Los Angeles-based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice, is the exclusive worldwide licensee of UCLA's TNS intellectual property.  "We are extremely pleased to be working closely with Dr. DeGiorgio and his talented and dedicated team at UCLA, to help make his vision of a safe, non-invasive therapy for epilepsy a reality," said Dr. Le
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SOURCE NeuroSigma
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