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FDA approves first medical device to treat child inattention

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The U.S. Food and Drug Administration (FDA) approved this week the first medical device to treat attention deficit hyperactivity disorder (ADHD) for children.

The device called the Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD authorized for marketing by the FDA.

The prescription-only device is indicated for patients ages 7 to 12 years old who are not taking ADHD medication.

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

ADHD is a common disorder that begins in childhood. ADHD patients have difficulty in staying focused and paying attention.

The cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows, according to FDA.

The device delivers the low-level electrical stimulation to the branches of the trigeminal nerve, sending therapeutic signals to the parts of the brain thought to be involved in ADHD.

Brain imaging showed that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior, but the exact mechanism of eTNS is not yet known.

The stimulation feels like a tingling sensation on the skin, and the device should be used in the home under the supervision of a caregiver during periods of sleep. Clinical trials suggest that a response to eTNS may take up to four weeks to become evident.

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