First Non-Drug Device for Treating Kids With ADHD Gets the Green Light in the U.S.

ADHD is one of the most common behavioral disorders in kids, affecting around 3 to 5 percent of Filipino children. Kids diagnosed with the disorder have trouble paying attention, act without thinking or are very impulsive, and tend to be overly active. These symptoms do not go away or lessen on their own, and along with therapy, children with ADHD may need medication. But a new device that promises to help manage the disorder without the use of drugs has been approved for sale in the United States.

The U.S. Food and Drug Administration (FDA) recently granted clearance to market the first non-drug treatment for ADHD, described as a “cellphone-sized” device that sends a low-level electrical pulse to areas of the brain responsible for ADHD symptoms.

Formally known as "Monarch external Trigeminal Nerve Stimulation (eTNS) System," the device is designated for children ages 7 to 12 who are NOT currently taking any medication for the disorder.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.

Manufactured by NeuroSigma, a life sciences company based in California, the eTNS system will only be made available through a prescription and must be used at home under the supervision of a parent, guardian, or caregiver.

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How the eTNS system works

The device generates a low-level electrical pulse and connects via a wire to a small patch that sticks to the child’s forehead, just above the eyebrows. “The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD,” according to the FDA.

It is designed to be connected while the child is sleeping and will feel like a “tingling sensation” on the skin. Neuroimaging studies have shown that the device increases activity in areas of the brain that regulate attention, emotion, and behavior, but the FDA says it might take up to four weeks of use to see noticeable differences.

To test the device’s efficacy, 62 children with moderate to severe ADHD were asked to participate in a clinical trial that compared the eTNS as the sole treatment to a placebo device. Every night for four weeks, the kids used either the eTNS therapy or the placebo device. At the end of the trial, children who used the eTNS recorded lower ADHD symptoms, which includes difficulty staying focused and paying attention, compared to those who used the placebo.

While the trial concluded with no serious side effects, the FDA did note common side effects like drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache, and fatigue.

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Studies are needed for this ADHD-related device

While the trial seems promising, experts believe that further research is needed to see whether the device is truly effective or not. Stephen Hinshaw, a professor of psychology at University of California, tells CNN that the FDA approval was based on a “single, small, short-term trial — which did not compare eTNS to established treatments.”

Kids diagnosed with ADHD are typically treated through a combination of therapy and medication. “For preschool-aged children (4 to 5 years old) with ADHD, behavior therapy is recommended as the first line of treatment,” according to the US Centers for Disease Control and Prevention.

Older children may be prescribed drugs. “Certain medicines assist people with ADHD in their focus and task commitment. Methylphenidate drugs affect chemical signals in the central nervous system, helping those with ADHD to perform better in school or work,” writes Frances Mijares-Magtoto, a special education specialist, in a previous SmartParenting.com.ph article.

Currently, the eTNS device is available in the United States and costs over $1,000 (around Php53,000) for the starter kit. It was previously approved for the treatment of epilepsy and depression in Europe and Canada, according to CNN.

The device is not intended for kids under 7 years old nor for patients with an active implantable pacemaker or neurostimulators. Those who use body-worn devices like insulin pumps are also not advised to use the eTNS system.

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