FDA clears first device treatment for childhood ADHD

NeuroSigma's Monarch system previously received CE marks for ADHD in adults and children over age 7, and in major depressive disorder in patients older than 9. (FDA)

The FDA has cleared the first medical device for treating attention deficit hyperactivity disorder (ADHD): an at-home nerve stimulation system designed for children ages 7 to 12.

The prescription-only treatment—NeuroSigma’s Monarch external trigeminal nerve stimulation system—is designed for children who are currently not taking any medications. About the size of a cellphone, the device delivers a mild electrical pulse to a wired patch placed on the patient’s forehead while sleeping.

By stimulating the branches of the trigeminal cranial nerve, it is believed the system triggers therapeutic signals sent to the parts of the brain involved in ADHD, although the exact mechanism is not known. Neuroimaging studies have shown that eTNS increases brain activity in regions related to attention, emotion and behavior, according to the FDA.


How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

“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, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, which granted the device a de novo clearance.

In a placebo-controlled clinical trial of 62 children, the Monarch system demonstrated significant improvements in an ADHD symptom scale after four weeks. According to the FDA, it may take at least one month for the treatment to deliver a noticeable effect; after that time, caregivers should consult their providers to reassess the treatment.

While no serious adverse events were observed, the most common side effects were drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. The device should not be used in patients with implanted pacemakers or neurostimulators, nor wearable insulin pumps.

The Los Angeles-based NeuroSigma previously received a CE mark for its device in late 2015 for use in adults and children over age 7, representing the first nondrug ADHD treatment in the EU. The Monarch system has also received a CE mark in major depressive disorder in patients older than 9.

Suggested Articles

Medtronic has received FDA approval for a drug-coated balloon designed to clear the access points used by patients undergoing dialysis treatments.

J&J's DePuy Synthes division has launched a new fixation system to expand treatment options for patients with frail bones in the neck and upper back.

Horizon Therapeutics is expanding its U.S. footprint to the Bay Area—the company unveiled a new R&D and manufacturing site in South San Francisco.