The FDA has permitted marketing of the first, prescription-only medical device for ADHD — the Monarch external Trigeminal Nerve Stimulation, or eTNS, System — for children aged 7 to12 years not currently taking prescription ADHD medication, according to a press release.
“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, PhD, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in the release.
The Monarch eTNS System, a cellphone-sized device that generates a low-level electrical stimulation to the branches of the trigeminal nerve and connects via wire to patches that adhere to the patents’ forehead, should be used at home under caregiver supervision during sleep, according to the release.
The FDA has permitted marketing of the Monarch external Trigeminal Nerve Stimulation System for children with ADHD aged 7 to12 years not currently taking prescription ADHD medication, according to a press release.
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Prior research has indicated that eTNS therapy was effective and safe for pediatric ADHD.
In a trial, children with ADHD who used either eTNS therapy each night for 4 weeks had statistically significant improvement in their ADHD symptoms using the eTNS device compared with those using a placebo device and had a greater decrease in clinician-administered ADHD Rating Scale score after 4 weeks of treatment, according to the release. No serious adverse events were associated with use of eTNS; common adverse effects included drowsiness, increase in appetite, trouble sleeping, teeth clenching, headache and fatigue.
Patients may not show response to eTNS for up to 4 weeks and should consult with their health care professional after 4 weeks of use to examine treatment effects, according to the release. The FDA granted marketing authorization of the Monarch eTNS System to NeuroSigma.