September 7, 2012 — An external trigeminal nerve stimulation (eTNS) system (Monarch, NeuroSigma, Inc) has received European Union (EU) CE Certification for the adjunctive treatment of epilepsy and major depressive disorder for adults and children aged 9 years and older.
The device has been evaluated in clinical trials conducted at the University of California, Los Angeles (UCLA) and the University of Southern California. It consists of an external pulse generator and disposable electric patches placed on the forehead that are replaced daily and are worn primarily during sleep.
“In clinical studies, eTNS was well tolerated and has been shown to substantially reduce seizures in patients with epilepsy and improve mood in patients with depression,” note the manufacturers in a written release. The company says that they are planning to make the device available in the fourth quarter of 2012 in the EU and will seek approvals in other parts of the world.
In the United States, the company will be submitting a request to the US Food and Drug Administration for an Investigational Device Exemption to commence a multicenter eTNS pivotal trial in epilepsy.
According to the release, trigeminal nerve stimulation was developed at UCLA and is exclusively licensed to NeuroSigma. Research efforts were led by Dr. Christopher DeGiorgio, MD, vice-president of neurology at NeuroSigma and professor of neurology at UCLA School of Medicine.
“As a non-invasive neuromodulation therapy, trigeminal nerve stimulation may represent a paradigm shift in the way we treat major depression and offers the potential to significantly improve the lives of millions of people without the side-effects common to medication treatment,” said Ian A. Cook, MD, who led clinical and human mechanism of action studies of the device in depression.
Dr. Cook is a senior medical advisor to NeuroSigma and a professor-in-residence at UCLA School of Medicine’s Department of Psychiatry, where he serves as director of the UCLA Depression Research and Clinic Program.
The company is currently developing an implantable TNS system, the release notes.