news 4 months ago

FDA just approved an electric ‘shock’ device to treat kids with ADHD

BGR — Mike Wehner

Shock therapy might sound outdated and even somewhat archaic, but low levels of electric stimulation has proven to have a variety of benefits when used appropriately. The FDA just gave a thumbs up to the first-ever “shock” device for use on children with ADHD, but it’s not nearly as intense as it might sound.

Far from a powerful electric “zap,” the device, called the Monarch external Trigeminal Nerve Stimulation System (eTNS for short), produces what doctors consider to be therapeutic levels of stimulation to parts of the brain that have been linked to symptoms of ADHD.

An FDA press release offers a summary of how the device is used:

As an alternative to prescription drugs, a device like this could be hugely beneficial while mitigating side effects, but the fact that it has to be worn on the forehead may significantly limit its appeal. The eTNS system is meant to be used while a child sleeps, and it’s being marketed for children between the ages of 7 and 12. Noticeable results can take up to four weeks.

It’s also worth mentioning that while the eTNS system seems to have real benefits in enhancing attention and managing behavior in hyperactive children, scientists still don’t know exactly why it works. Clinical studies have shown that the stimulation is indeed affecting the brain, but “the exact mechanism of eTNS is not yet known,” the FDA notes.

The FDA has given clearance for marketing of eTNS via its streamlined review system for what it considers to be “low- to moderate-risk devices of a new type,” which is an important distinction from its rigorous testing of products like prescription drugs. NeuroSigma, the company behind the device, is now free to sell and advertise the gadget as a potential treatment for ADHD in children.

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