FDA approves first medical device to treat child inattention – Xinhua


WASHINGTON, April 20 (Xinhua) – The US Food and Drug Administration this week approved the first medical device to treat attention deficit hyperactivity disorder (ADHD) for children.

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

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

"This new device offers a safe and non-medical option for the treatment of ADHD in pediatric patients through the use of mild first-of-kind nerve stimulation," said Carlos Pena, director of the Devices Division of Physical and Neurological Medicine at the Center for Devices and Radiological Health of the FDA.

ADHD is a common disorder that begins in childhood. Patients with ADHD have difficulty keeping focus and paying attention.

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

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

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

Stimulation looks like a tingling sensation in the skin, and the device should be used at 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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