NINDS awards NeuroSigma STTR Phase I grant to support development of eTNS therapy for epilepsy

NeuroSigma, Inc., a Los Angeles-based medical device company, today announced it has received a notice of award for an NIH Small Business Technology Transfer (STTR) Phase I grant from the National Institute of Neurological Disorders and Stroke (NINDS).  This will support further development of external trigeminal nerve stimulation (eTNS™) therapy for the treatment of drug-resistant epilepsy, for which NeuroSigma is the exclusive worldwide licensee of intellectual property developed by the University of California, Los Angeles (UCLA).  The STTR program requires that the small business collaborates with a non-profit research institution, which must perform at least 30% of the work.  UCLA's role as a subcontractor in this project is primarily focused on conducting the human clinical studies.

NeuroSigma's grant award from NINDS extends over a period of approximately two years and will provide total funding of approximately $750,000, with the second year of funding subject to the availability of funds and satisfactory progress during the first year.  The NINDS STTR program may provide up to an additional $3 million of follow-on Phase II funding for additional clinical studies.  The major focus of the project is clinical testing of a new proprietary eTNS™ pulse generator and animal and human testing of a new generation of electrodes designed to mitigate minor skin irritation, which was the primary side-effect reported by subjects in the Phase I and recently completed Phase II clinical trials.

NeuroSigma's 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 of the forehead.  The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain.  

Drs. Christopher DeGiorgio and Ian Cook, UCLA faculty in the Departments of Neurology and Psychiatry, are the principal investigators of this project.  Together they have pioneered TNS for epilepsy, depression, post-traumatic stress disorder and other indications.

"We have already seen the safety and efficacy of our non-invasive eTNS™ therapy in prior clinical trials and look forward to the opportunity to further validate our therapy through the valuable funding provided by NINDS," said Dr. DeGiorgio.  "We are also very pleased to receive this grant knowing that NIH's highly regarded peer review process includes a rigorous review by leading medical experts."