The Food and Drug Administration (FDA) has permitted for marketing the first medical device indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

The Monarch external Trigeminal Nerve Stimulation (eTNS) System (NeuroSigma) is approved for patients 7-12 years of age who are not being treated with ADHD medications; the device is intended for use at home under caregiver supervision during periods of sleep. The Monarch eTNS works by delivering a low-level electrical pulse to the trigeminal nerve through a small patch that is placed on the patient’s forehead.

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The safety and efficacy of the device was evaluated in a clinical trial involving 62 children with moderate to severe ADHD. Patients were randomized to the eTNS device or placebo device for 4 weeks. The primary outcome measure of the study was improvement in clinician-administered ADHD Rating Scale (ADHD-RS), with a higher score indicating worsening symptoms.

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Results showed that treatment with the eTNS device led to statistically significant improvement in ADHD symptoms compared with placebo (eTNS: ADHD-RS score decreased from 34.1 points to 23.4 points; placebo: ADHD-RS score decreased from 33.7 points to 27.5 points). With regard to safety, drowsiness, increased appetite, sleep disturbance, teeth clenching, headache, and fatigue were the most common adverse reactions associated with eTNS therapy.

The eTNS device should not be used by patients with an active implantable pacemaker or implantable neurostimulator, and in those with body-worn devices (i.e., insulin pumps); it should also not be used in the presence of radiofrequency energy, such as with MRI or cell phones.

“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, PhD, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.

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This article originally appeared on MPR