FDA Approves First Device for Treatment of ADHD

The Food and Drug Administration (FDA) announced that it is permitting the marketing of the first medical device for the treatment of attention-deficit/hyperactivity disorder (ADHD). The device is the Trigeminal Nerve Stimulation (eTNS) System by Monarch. It will be available by prescription only and is indicated for children aged 7 to 12 years who are not taking ADHD medications.

The Monarch eTNS System delivers low-level electrical pulses to a child’s trigeminal nerve via wires and a small patch adhered to the child’s forehead while the child sleeps. The exact mechanism of eTNS is not yet known, but neuroimaging studies have shown that the trigeminal nerve connects to brain regions that are important in regulating attention, emotion, and behavior.

The efficacy of the Monarch system was shown in a recently published clinical trial of 62 children with ADHD. The participants randomly received either eTNS or sham nerve stimulation nightly for four weeks. At the study’s completion, the children using the eTNS device had a statistically significant improvement in their ADHD symptoms compared with the sham group, as measured with the clinician-administered ADHD Rating Scale. The device was well tolerated; the most common side effects observed with eTNS were drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue.

Source: Psychiatric News (APA)