The Food and Drug Administration will allow marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD), said the agency in a news release. The Monarch external Trigeminal Nerve Stimulation (eTNS) System, available from NeuroSigma by prescription only, is a cell-phone sized neve stimulator for use by young patients ages 7 to12 years old who are not currently taking prescription ADHD medication. This is the first non-drug treatment for ADHD granted marketing authorization by the FDA, said the agency.
“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in an agency release.
The Monarch eTNS System is for home-use with help from a caregiver. Used during periods of sleep, the device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows, and should feel like a tingling sensation on the skin, explained the FDA. The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.
Clinical trials suggest that a response to eTNS may take up to 4 weeks to become evident but did show efficacy in treating ADHD during a clinical trial of 62 children which compared eTNS as the sole treatment, or monotherapy, to a placebo device.
A clinician-administered ADHD Rating Scale, ADHD-RS was used to monitor severity and frequency of ADHD symptoms, which higher scores pointing to worsening symptoms. Kids who used the eTNS device had much less symptoms compared with the placebo group. At the end of week four, the average ADHD-RS score in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the placebo group.
The FDA said it reviewed the Monarch eTNS System through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
