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.”