The U.S. Food and Drug Administration (FDA) sparked headlines this month when it approved a nerve-stimulation device to treat ADHD in children. This is the first time the FDA has approved an ADHD treatment that is not a drug.
Who is the ADHD device for?
It has been approved in the United States as an ADHD treatment for children ages 7 to 12. The device has also been approved in Europe and Canada to treat epilepsy and depression.
How does it work?
Kids wear the device, which is about the size of a cell phone, when they sleep. It’s connected by wire to a patch that sticks to the forehead. The device generates a low-level electrical pulse. It stimulates a large nerve called the trigeminal nerve. That’s why this treatment approach is called trigeminal nerve stimulation (TNS).
TNS increases activity in key parts of the brain. These areas “are known to be important in regulating attention, emotion, and behavior,” the FDA said in a press release about approving the device.
What does FDA approval mean?
It means the device can be marketed in the United States as a medical treatment for ADHD.
“It’s exciting to have more treatment options. But we need to be cautious,” says Harstad. She’s a developmental-behavioral pediatrician at Boston Children’s Hospital. She’s also a pediatrics instructor at Harvard Medical School.
“FDA approval doesn’t necessarily mean that TNS is definitely a safe and effective treatment for ADHD,” says Harstad. “The results of one small clinical trial doesn’t mean a new treatment is ready to be widely used in clinical care.”
Which studies helped the device get FDA approval?
The FDA cited a clinical trial that compared the ADHD symptoms of two groups of kids: those using the device and those using a placebo. That study showed that ADHD symptoms improved more in kids using active devices than in kids using sham ones.
Kids tolerated the treatment pretty well. The most commonly reported side effects were feeling sleepy, wanting to eat more, and having trouble sleeping.
The study was designed so families and clinicians wouldn’t know which kids had active devices and which kids had placebos. And that’s a good thing. This approach kept people’s beliefs from biasing the results.
But the study has some shortcomings, according to Dorta. He’s a pediatric neuropsychologist in New York City. He’s also an assistant professor at Columbia University’s College of Physicians and Surgeons.
Here are some of his concerns about the clinical trial:
- Size: The study wasn’t very big. With a total of 62 children, 32 used active devices and 30 used sham ones.
- Length of time: The study was short. Kids were observed for just four weeks of nightly treatment and one week without any treatment.
- Financial disclosures: The maker of the device—NeuroSigma—has ties to two of the study’s co-authors. One of them is NeuroSigma’s chief medical officer.
“This kind of disclosure always raises concern about a study’s results,” says Dorta. “I want the device to be studied by other teams that don’t have any ties to the company. I want these other researchers to confirm the device is safe and effective before I’d suggest using it.”
Anything else families need to know?
The device is available only by prescription. According to the FDA, the device should not be used:
- Near a cell phone, because the phone’s signals may interrupt the therapy
- By children with pacemakers or insulin pumps
- By children who are currently taking ADHD medication
The device has only been studied as a “monotherapy” for ADHD. This means it’s used by itself—not in combination with other treatment.
But what about the kids with ADHD who also need to be treated for other health conditions? Harstad notes that ADHD often co-occurs with conditions like depression and autism. “The study’s results need to be replicated in larger, more diverse samples of children,” she says.
Dorta agrees. “In general, the FDA doesn’t require as much data to approve a device as it does to approve a medication,” he says. “This new ADHD treatment is still highly experimental. More research is needed on the safety and benefits of using TNS to treat ADHD.”
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Julie Rawe is the special projects editor at Understood.