Yet Another Success for the Epilepsy Therapy Project - eTNS Approved in Europe
Earlier this year, two ETP-supported projects, the Visualase MRI-Guided thermal laser ablation system for epilepsy surgery and the SmartWatch motion detector and caregiver notification device became available for patients with epilepsy. The ETP is now proud to announce that a third ETP-supported project has been formally approved in Europe. Approval in the United States is pending. ETP support is a 50-50 partnership with the Epilepsy Foundation.
Trigeminal nerve stimulation (TNS) for the treatment of epilepsy was originally developed at UCLA. In 2007, UCLA School of Medicine received a $167,000 New Therapy grant for a clinical trial of its innovative TNS system for intractable epilepsy. In 2010, the rights to it were exclusively licensed to NeuroSigma, a company based in Los Angeles, California. The good news is that the first of two NeuroSigma systems, the Monarch external Trigeminal Nerve Stimulation (eTNS) system has been approved in Europe. The Monarch is indicated as an adjunctive treatment of epilepsy and major depressive disorder for patients over 9 years of age, according to the announcement. The eTNS is a non-invasive stimulator of the forehead branches of the trigeminal nerve. Daily disposable patches are applied to the forehead and connected to a belt-worn pulse generator that delivers electric signals to the nerve. Users will typically wear it at night during sleep, although, depending on what their doctors say, they may choose to use it during their daily routines as well.
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain. The trigeminal nerve projects to specific areas of the brain which are involved in epilepsy, and other disorders. Imaging studies in humans confirm that eTNS activates or inhibits key brain regions implicated in these disorders—changes in the brain were often observed within minutes of therapy.
A second device, sTNS, uses small subcutaneous electrodes and an implantable pulse generator to stimulate the trigeminal nerve. Although the recently-approved eTNS is a stand-alone therapy, patients who respond well to eTNS may eventually opt for the implantable sTNS system, which NeuroSigma is currently developing.
See ETP's Epilepsy Therapy Pipeline for other therapies in development