NeuroSigma Provides Update on Trigeminal Nerve Stimulation (TNS) - the USB Port to the Brain™ Key Phase II TNS epilepsy results to be reported this week in Miami

LOS ANGELES, April 25, 2011 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based medical device company, today announced research progress on three therapies employing trigeminal nerve stimulation (TNS), originally developed at UCLA and exclusively licensed to NeuroSigma.

Background - TNS

NeuroSigma is developing two embodiments of TNS: eTNS™ (TNS with external electrodes and an external pulse generator) and sTNS™ (subcutaneous electrodes and implantable pulse generator).

The eTNS™ system utilizes a self-adhesive conductive pad applied to the forehead to stimulate branches of the trigeminal nerve, which are located very close to the surface of the skin above the forehead.  The trigeminal nerve is one of the largest in the body, offering a high-bandwidth pathway for signals to enter the brain.  In clinical studies, eTNS™ is well tolerated and the low-energy stimulus is confined to the soft tissues of the face without penetration into the brain – thus appropriately coined the USB Port to the Brain™.

The trigeminal nerve projects to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus and the cerebral cortex, which are involved in epilepsy, depression, PTSD and other disorders. PET imaging studies in humans confirms that eTNS™ activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy.

Once approved by regulatory agencies, patients who respond well to eTNS™ can opt to switch to the implantable sTNS™ system.  NeuroSigma is developing its own proprietary eTNS™ system but contemplates partnering for sTNS™ with other medical device companies, which already have commercially available implantable neurostimulation systems.

TNS for Epilepsy

An open-label Phase I eTNS™ trial at UCLA with 13 patients generated very promising efficacy and safety data (http://newsroom.ucla.edu/portal/ucla/unique-nerve-stimulation-device-85136.aspx).  This feasibility study set the stage for a just-completed double-blind Phase II study at UCLA and USC.  

Christopher DeGiorgio, M.D., a UCLA neurologist and the principal investigator of the Phase II eTNS™ double-blind epilepsy trial will be presenting results from the study this Thursday, April 28, 2011, at the Epilepsy Therapy Project's conference in North Miami Beach (http://www.epilepsy.com/etp/aedtrialxi).

TNS for Depression

In a feasibility study of five subjects, eTNS™ was used adjunctively in adults with major depressive disorder who were symptomatic despite the use of appropriate pharmacotherapy. A UCLA team led by Ian A. Cook, M.D. the Joanne and George Miller Family Chair in Depression Research at the Semel Institute, found highly significant decreases in depressive symptom severity using standard depression rating scales over eight weeks of adjunctive eTNS™. (http://newsroom.ucla.edu/portal/ucla/non-invasive-therapy-significantly-169741.aspx)

Based on the results of this feasibility study, UCLA has begun a twenty-subject, Phase II double-blind trial, funding to be provided by NeuroSigma, to assess the safety and efficacy of eTNS™ as a potential adjunctive therapy for the treatment of depression.

TNS For Post-Traumatic Stress Disorder (PTSD)

UCLA just commenced and is actively recruiting subjects for a Phase I feasibility trial, funding to be provided by NeuroSigma, to assess the safety and efficacy of eTNS™ as adjunctive therapy for the treatment of PTSD.

Some research suggests that intervening soon after a traumatic event is likely to reduce the development of chronic PTSD.  This could be important for both civilian and military related cases of PTSD since eTNS™ treatment can be administered on the same day of the trauma and in the field. Information about the trial is available through ClinicalTrials.gov or DepressionLA.com (http://www.clinicaltrials.gov/ct2/show/NCT01335217)

CAUTION: Both eTNS™ and sTNS™ systems are investigational devices and at this time are limited by United States law for investigational use only.

About NeuroSigma, Inc.

NeuroSigma is a Los Angeles-based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice.  Currently we have a specific focus on neuromodulation.  NeuroSigma employs two therapy platforms: Trigeminal Nerve Stimulation (TNS) and Deep Brain Stimulation (DBS).  NeuroSigma has amassed significant intellectual property licensed on an exclusive basis from UCLA, including potential therapies for epilepsy, depression and post-traumatic stress disorder (PTSD) via TNS and for PTSD, obesity and cachexia via DBS.  For more information about NeuroSigma, visit our website at http://www.neurosigma.com

SOURCE NeuroSigma, Inc.



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