Monarch eTNS Nerve Stimulation System receives EU CE Mark approval for Attention-Deficit/Hyperactivity Disorder- NeuroSigma

NeuroSigma has received CE Mark approval for its Monarch eTNS System as treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children age 7 and older. This CE Mark approval is the first for any non-drug treatment of ADHD in the European Union (EU).

The Monarch eTNS system is composed of a cell-phone sized pulse generator and a single-use electric patch that is applied to the forehead. Signals are transmitted through lead wires to the patch in order to stimulate the trigeminal nerve in the skin of the forehead; triggering these nerve fibers sends signals to targeted brain regions and changes the activity there. Patients may conveniently self-administer the Monarch eTNS system at home and typically use the device while sleeping.

Currently, a 90-subject double-blind Phase II trial of eTNS for ADHD is being conducted at UCLA with funding from the U.S. National Institutes of Health. The trial is led by James McGough, Professor of Clinical Psychiatry at UCLA.