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FDA OKs first medical device to treat ADHD in children

The device delivers a low-level electrical pulse to the parts of the brain responsible for ADHD symptoms.

Posted: Apr 22, 2019 7:18 AM
Updated: Apr 22, 2019 7:22 AM

(CNN) -- The first medical device to treat childhood attention deficit hyperactivity disorder, or ADHD, was OK'd Friday by the US Food and Drug Administration.

Designated for children ages 7 to 12 who are not currently on medication for the disorder, the device delivers a low-level electrical pulse to the parts of the brain responsible for ADHD symptoms.

"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, director of the Division of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, said in a statement.

Called the Monarch external Trigeminal Nerve Stimulation System, eTNS,and marketed by NeuroSigma, the treatment is only available by prescription and must be monitored by a caregiver.

The pocket-sized device is connected by wire to a small adhesive patch placed on the child's forehead above the eyebrows.

Designed to be used at home while sleeping, it delivers a "tingling" electrical stimulation to branches of the cranial nerve that delivers sensations from the face to the brain.

The device was previously approved for the treatment of epilepsy and depression in Europe and Canada and has also been investigated as a possible treatment for traumatic brain injury in veterans.

The device should not be worn by children under the age of 7, or any child on an insulin pump, pacemaker or implanted neurostimulator.

It should also not be used near a cell phone, the FDA said, because the phone's low levels of electromagnetic energy may interrupt the therapy.

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