FDA Signs Off on First Medical Device for Treating ADHD in Children


From USA TODAY: “Called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, the prescription-only device is for children ages 7 to 12 who are not taking ADHD prescription medication.

The Monarch eTNS – an instrument the size of a cellphone – is designed for use at home with adult supervision. It connects via wire to a small patch placed on the forehead of the patient, generating a low-level electrical pulse to the brain. […]

A trial of 62 children with moderate to severe ADHD showed subjects using the eTNS had ‘statistically significant improvement’ compared with ADHD children who were given a placebo device.

After four weeks into the study, the average ADHD-RS score – used to measure ADHD – had decreased from 34.1 points to 23.4 points. That’s compared with a decrease of 33.7 to 27.5 points among the placebo group.”

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  1. “The FDA said the Monarch eTNS has several side effects – drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue – but no serious adverse events associated with its use.” To me, a child that suffers from these symptoms has serious adverse events.