The FDA has permitted the marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for patients 7 to 12 years of age who are not currently taking prescription ADHD medication.
The Monarch eTNS System offers a safe, non-drug option for pediatric patients with ADHD through mild nerve stimulation. The device connects via a wire to a small patch that adheres to a patient’s forehead. The system, available by prescription only, is designed for home use, under caregiver supervision, while the patient is sleeping.
Monarch delivers low-level electrical stimulation to the trigeminal nerve branches, which sends therapeutic signals to the parts of the brain believed to play a role in ADHD. Neuroimaging studies show that eTNS increases activity in brain regions that are important in regulating attention, emotion, and behavior.
The system’s efficacy in treating ADHD was shown in a clinical trial with 62 children comparing eTNS (as the sole treatment) to a placebo device. Patients had moderate to severe ADHD and used either the eTNS therapy or a placebo device at home each night for four weeks.
Patients using eTNS had statistically significant improvement in their ADHD symptoms compared with placebo. At the end of week four, the average ADHD Rating-Scale score in the eTNS group had decreased from 34.1 points at baseline to 23.4 points, compared with a decrease from 33.7 to 27.5 points in the placebo group.
Among the most common side effects observed with eTNS were drowsiness, increased appetite, difficulty sleeping, teeth clenching, headache, and fatigue. No serious adverse events were associated with use of the device.
The FDA reviewed the Monarch eTNS System through the de novo premarket review pathway, and granted marketing authorization of the system to NeuroSigma.
Source: FDA, April 19, 2019