FDA Approves First, Non-Drug Medical Device To Treat Children With ADHD

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The treatment would replace drugs like Adderall and Ritalin, which have serious side effects.

According to CBS, the FDA has just approved the first, non-drug medical device to treat children with ADHD. The device delivers low-level electrical pulses through a patch attached to the child’s forehead. Children aged 7 to 12 years-old will be able to use this treatment.

The device, which is approximately the size of a cell phone with a wire that attaches to the patch, increases the activity in areas of the brain important for regulating attention and behavior. The patch is worn overnight.

"It emits a low level electrical pulse that essentially stimulates a cranial nerve called the trigeminal nerve and the idea is that nerve then sends signals into the brain particularly to the areas that are important for attention, for functioning and behavior," Dr. Tara Narula said on "CBS This Morning." "And they did see in this small study of about 60 kids over four weeks it did reduce symptoms. It seems to be on par with the effects seen with non-stimulant medications."

Some side effects occurred, such as drowsiness, fatigue, increased appetite, teeth clenching, and headaches.

"But as I said it was a small study and it was over a short period of time. We don't know what it would be like if kids were on medication when they used this," she said.

In the U.S. alone, it is estimated that 6.1 million children have been diagnosed with ADHD. It is extremely difficult to diagnose.

"The important thing is that it's pervasive, so you see it at school and at home. It persists for longer than six months and it affects function. If their function is limited academically, socially, emotionally, that's when you might want your child to be seen and evaluated and they may in fact have it," Narula said.

"We know that a third of these kids have other disorders like anxiety disorders or mood disorders," she explained. "A third will go on to get symptoms into adulthood and the issue is that it really can be associated with increased risk of substance abuse, injuries, either accidental or intentional, poor self-esteem, poor academic performance. So it's important to identify it – really truly identify it – and get kids treated for it."

ADHD is usually treated by drugs like Ritalin or Adderall, which have side effects like anorexia and cardiovascular difficulties.

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