NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company, announced that it 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).
"ADHD is estimated to affect up to 9.5 per cent of school age children and 4.4 per cent of adults, and many people have concerns about using stimulant medications. In research conducted at the University of California, Los Angeles (UCLA), eTNS was well accepted by children and their parents, and produced significant improvements in the behavioural symptoms of ADHD as well as in cognition," said Ian A. Cook, M.D., NeuroSigma's chief medical officer.
"eTNS is non-invasive, can be administered at home, and has none of the serious side effects of the stimulant medications that are currently being used to treat ADHD. As a result, we believe that eTNS will become a preferred, drug-free treatment for many children and adults in the EU with ADHD."
Currently, a 90-subject double-blind trial of eTNS for ADHD is being conducted at UCLA with funding from the US National Institutes of Health (www.ADHD-LA.com). The trial is led by James McGough, M.D., M.S., professor of clinical psychiatry at UCLA.
"I am excited and encouraged that we found a significant improvement in ADHD symptoms with eTNS in our Phase I open-label trial, and am eager to complete the current double-blind trial," said Dr. McGough.
NeuroSigma is focused on commercialisation of its non-invasive eTNS technology for the treatment of neurological and neuropsychiatric disorders. With this approval, NeuroSigma's Monarch eTNS system is now available in the European Union for the treatment of ADHD and for the adjunctive treatment of major depressive disorder and epilepsy for adults and children seven years and older.
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.
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. The trigeminal nerve projects directly or indirectly to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus, and the cerebral cortex, which are involved in epilepsy, depression, ADHD, post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and other disorders.
Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, including those located near the surface of the forehead. Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.
