FDA Clears First ADHD Treatment Device

The FDA has cleared for marketing the first medical device for the treatment of attention-deficit/hyperactivity disorder (AHDH). The Monarch external Trigeminal Nerve Stimulation (eTNS) System is a prescription-only device indicated for use in patients aged 7 to 12 years who are not currently taking prescription ADHD medication.

The device delivers low-level electrical pulses to the branches of the trigeminal nerve through a wire and small patch adhered to the patient’s forehead. It should be used under the supervision of a caregiver during periods of sleep.

The device’s efficacy was assessed in a clinical trial of 62 children with moderate-to-severe ADHD who used either the eTNS system or placebo for 4 weeks. Overall, those who used eTNS had statistically significant improvement in their ADHD symptoms compared with those using placebo.

The most common side effects observed with the use of eTNS were drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue.

—Michael Potts

Reference:

FDA permits marketing of first medical device for treatment of ADHD [press release]. April 19, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636379.htm.