NeuroSigma announced it has received a notice of award for a National Institutes of Health (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, USA.
The STTR program requires that the small business collaborate with a non-profit research institution, which must perform at least 30% of the work. The University of California will be conducting the human clinical studies.
The award from NINDS extends over a period of approximately two years and will provide total funding of approximately US$750,000, with the second year of funding subject to the availability of funds and satisfactory progress during the first year. The NINDS STTR programme may provide up to an additional US$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.
The eTNS system utilises a self-adhesive conductive pad applied to the forehead to stimulate branches of the trigeminal nerve which is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain.
Christopher DeGiorgio and Ian Cook, Departments of Neurology and Psychiatry, University of California, are the principal investigators. Together they have pioneered trigeminal nerve stimulation 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 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.”