eTNS therapy can impact symptoms in pharmacoresistant major depression

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.

This Phase Ib study was an open-label clinical trial of eTNS™ therapy in adults with non-psychotic unipolar MDD that had lasted more than 4 months and had not responded to at least one antidepressant, with a median of 4 medication failures.  Clinical improvements were consistently found across several different ways to measure symptom burden.  

The TNS technology, including eTNS™ for the treatment of depression, was invented and originally 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. Cook and his talented and dedicated team at UCLA," said Dr. Leon Ekchian, President and CEO of NeuroSigma.  "We look forward to helping make his vision of a safe, non-invasive, non-pharmacological therapy for depression available to patients worldwide."

NeuroSigma has completed development of its external TNS (eTNS™) system and is developing its implantable subcutaneous TNS (sTNS™) system.  Once approved by regulatory agencies, patients who respond well to eTNS™ can opt to switch to the implantable sTNS™ system.  Near term milestones include filing a CE Mark application in mid-2012 for approval to commence marketing the eTNS system for the treatment of epilepsy and depression in Europe, and in the second-half of 2012, NeuroSigma is planning to file an IDE with the FDA for a multi-center epilepsy Phase III pivotal trial in the United States.