FDA Approves First Device to Treat ADHD

The first medical device to treat ADHD has been approved by the U.S. Food and Drug Administration for marketing by the device maker, NeuroSigma, Inc.

The Monarch external Trigeminal Nerve Stimulation (eTNS) System will be available, by prescription only, to children ages 7 to 12 who do not take ADHD medication.

According to an article in USA Today, the Monarch eTNS is a device about the size of a cell phone that is designed for home use by kids, with adult supervision.

It connects via wire to a small patch placed on the forehead of the patient, generating a low-level electrical pulse to the brain.

The connection provides a tingling sensation on the skin, and delivers a low-level electrical stimulation to the branches of the trigeminal nerve, which then sends therapeutic signals to the parts of the brain associated with ADHD. The FDA says that the eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.

In clinical trials with 62 kids who have moderate to severe ADHD, the Monarch eTNS proved significantly more effective in reducing ADHD symptoms after 4 weeks compared to the group using a placebo device.

The FDA lists several side effects associated with the device, including drowsiness, increased appetite, sleep trouble, teeth clenching, headache, and fatigue—but found “no serious adverse events associated with its use.”