First Medical Device Cleared by FDA to Treat Childhood ADHD

The at-home system from NeuroSigma stimulates nerves in children ages 7-12.


While there are many drugs on the market to treat attention deficit/hyperactivity disorder (ADHD), many parents of children with the disorder would prefer not to be medicating their children.

Fortunately, they will soon have a non-drug option. The U.S. Food and Drug Administration (FDA) has approved a medical device from NeroSigma to the treatment of children ages 7–12 with ADHD.


The Monarch external trigeminal nerve stimulation system is the first medical device approved by the agency for ADHD — it is intended for use by children that are not currently taking any medications. The cell phone–sized device delivers a mild electrical pulse to a wired patch placed on the patient’s forehead while sleeping. Although the exact mechanism of the therapeutic effect is not known, it has been shown that the resulting trigeminal cranial nerve stimulation triggers therapeutic signals sent to the parts of the brain involved in ADHD that increase brain activity in regions related to attention, emotion and behavior.

The FDA’s approval was based on the results of a clinical study conducted with 62 children. The device was shown to result in significant improvements in an ADHD symptom scale after four weeks compared with placebo. At least one month of treatment may be required before noticeable effects are observed, but no serious adverse events were observed.

Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications