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4 Things to Know About the New ADHD Treatment Approved by the FDA

Normally, we talk about treating ADHD with medications, not with “devices.” But the FDA recently gave the green light to market a new medical device for treating ADHD. In their press release, the FDA points out that this is the first time approval has been given to a non-drug ADHD treatment.

If that sounds like a big deal, well, it might be and it might not be. That will come down to how successful the treatment actually is. Here are 4 things you should know about it.

1. What is this new treatment?

The new device uses something called Trigeminal Nerve Stimulation, or TNS. Basically, you have a weak battery connected to an electrode that you attach to your forehead. According to the FDA, you’ll feel a “tingling sensation on your skin” when you apply the device.

BrainwavesSome research suggests that delivering an electrical pulse to your forehead in this way might help with ADHD symptoms. The reason for that is unclear, but one hypothesis is that certain brain regions get activated.

The device in its current form is intended for children between 7 and 12 years of age, and is supposed to be applied for 8 hours every night. It’s prescription-only, and something tells me that the black market for this device will be considerably less lucrative than the black market for Adderall.

2. What does it mean that it’s approved by the FDA?

So it’s “FDA-approved,” it must work! This term gets thrown around a lot, but basically all it means for something to be FDA-approved is that, based on what we know so far, the benefits appear to outweigh the risks.

And as far as we know, the risks of this treatment are low. Saying it’s FDA-approved doesn’t mean it’s a miracle cure, or that it’ll work for everyone. It just means that, going by the current evidence, it’ll probably help more than it hurts.

3. What’s the evidence behind this treatment?

The main basis for the FDA’s decision to approve this device is a clinical trial of 62 children led by researchers at UCLA. Half the children did the treatment for 4 weeks, and half did a “sham” placebo treatment.

Both groups rated their ADHD symptoms as improving, but the ones who underwent the real treatment saw their symptoms improve more. On the ADHD Rating Scale, the treatment group went from an average score of 34.1 to 23.4 while the placebo group went from 33.7 to 27.5.

This difference was statistically significant, suggesting that the TNS device really did help. Still, you’re not wrong if you’re a little underwhelmed by the results: the number of participants in the study was relatively small, some of the improvement is apparently from a placebo effect, and there’s no telling what the results would look like for a span of time more than four weeks.

The bottom line is that the results are promising, but still somewhat tentative. On the other hand, the risks appear to be minimal, hence the decision to approve the treatment.

4. Should I try it?

I’ll give the cop-out answer by saying that’s up to you. Ultimately it’s going to depend on how open you are to trying non-drug ADHD treatments.

The device, per the clinical trial, is apparently quite safe, and there’s at least some evidence that’s promising. So if you’re still trying to find the right ADHD treatment for your child (for now, the device is only for children), I can’t think of a reason not to try it other than the potential inconvenience. Either way, you’ll have to get a prescription to use it, so talk to your doctor!

Image: Flickr/TMAB2003

4 Things to Know About the New ADHD Treatment Approved by the FDA

Neil Petersen

Neil Petersen writes regularly on education, learning disabilities and technology. He received his B.A. in 2014 and was diagnosed with ADHD at the beginning of his college studies. Neil also works for a music education non-profit and hopes to help create an education system that can better serve students with ADHD.

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APA Reference
Petersen, N. (2019). 4 Things to Know About the New ADHD Treatment Approved by the FDA. Psych Central. Retrieved on June 16, 2019, from


Last updated: 1 May 2019
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