FDA Approves First Medical Device for Treating ADHD in Children
The nerve stimulation device cleared by the FDA generates low-level electrical stimulation to the forehead, which is shown to improve ADHD symptoms including inattention, impulsive behavior, and hyperactivity in children aged 7 to 12 years old after roughly four weeks of use.
April 23, 2019
The U.S. Food and Drug Administration (FDA) has approved marketing of the first non-drug medical device to treat attention deficit disorder (ADHD or ADD) in children aged 7 to 12 years old who are not currently taking prescription ADHD medication. The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, delivers a low-level electrical pulse to the patient’s forehead, stimulating branches of the trigeminal nerve and sending therapeutic signals to regions of the brain impacted by ADHD.
“The cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient’s forehead, just above the eyebrows, and should feel like a tingling sensation on the skin,” according to an FDA press release. “While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.”1
Patients should use the device during periods of sleep under the supervision of a caregiver. Results may take up to four weeks to appear — at which time patients should consult with their health care professionals to assess treatment effects, according to the FDA.
A small clinical trial of 62 children2 completed in 2018 showed a statistically significant improvement in ADHD symptoms among patients using the eTNS device compared to those in a placebo group. Using a clinician-administered ADHD Rating Scale (ADHD-RS) to measure outcomes, the researchers found that the average ADHD-RS score dropped from 34.1 to 23.4 points within the active group after four weeks. The average score for the placebo group dropped from 33.7 to 27.5 points during the same time period.
Observed side effects associated with the eTNS System included drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache, and fatigue. Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, says the device is the first of its kind to offer a “safe, non-drug option for treatment of ADHD in pediatric patients.”
1 FDA permits marketing of first medical device for treatment of ADHD. U.S Food and Drug Administration. (Apr. 2019) https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636379.htm
1 Trigeminal Nerve Stimulation for ADHD (TNS for ADHD). U.S National Library of Medicine. (Apr. 2019) https://clinicaltrials.gov/ct2/show/study/NCT02155608