FDA approves the first medical device to treat the inattention of children – Xinhua

WASHINGTON, April 20 (Xinhua) – The Food and Drug Administration (FDA) this week approved the first medical device to treat Attention Deficit Hyperactivity Disorder (ADHD) in children.

This device, called the external Monarch Trigeminal Nerve Stimulation (eTNS) system, is the first non-drug treatment for ADHD approved for marketing by the FDA.

The device reserved for the prescription is indicated for patients aged 7 to 12 years not taking medication for the treatment of ADHD.

"This new device offers a safe, non-drug option for the treatment of ADHD in pediatric patients through light nerve stimulation, a first of its kind," said Carlos Pena, director of Physical Medicine Devices Division and in the region. FDA Center for Appliances and Radiation Health.

ADHD is a common disorder that starts in childhood. Patients with ADHD have trouble staying focused and attentive.

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

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

Brain imaging has shown that eTNS increase activity in brain regions recognized to play an important role in the regulation of attention, emotions and behavior, but the exact mechanism of eTNS does not Is not yet known.

The stimulation provides a tingling sensation on 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 treatment with eTNS may take up to four weeks before becoming evident.