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

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From USA TODAY: “Called theĀ 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 ā€“ an instrument the size of a cellphone ā€“ is designedĀ for useĀ 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 ā€“ used to measure ADHD ā€“ 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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4 COMMENTS

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

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    • Duh, you think?????? I’m not directing this to you Marie but towards these idiots who never make the important connections. I agree with you; how can the things named not be serious in nature for kids? I agree with you 100%, these are serious, adverse events.

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