First medical device approved to treat children with ADHD

Known as the Monarch external Trigeminal Nerve Stimulation System, the device is approved for ADHD patients between the ages of 7 and 12 who are not currently taking prescription drugs to treat their condition.

"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 Dr. Carlos Peña, director of the FDA's division of neurological and physical medicine devices. 

The cellphone-sized device stimulates the trigeminal nerve by delivering a low-level electrical pulse through a wire connected to a small patch placed on the patient's forehead. The pulse sends therapeutic signals to portions of the brain believed to be involved in ADHD.

Neuroimaging studies show that it increases activity in the areas of the brain responsible for regulating attention, emotion and behavior, according to the FDA. Still, the exact mechanism of the system remains unknown.

The Monarch eTNS System should be used during periods of sleep and under the supervision of a caregiver, the FDA said. 

Clinical trials suggest it can take up to four weeks for an improvement in symptoms. 

Side effects include drowsiness, increased appetite, difficulty sleeping, teeth clenching, headaches and fatigue.

ADHD, which begins in childhood, affects millions of people.

Children with ADHD have difficulty staying focused and controlling their behavior. They also have high levels of activity. 

Diagnosis requires a comprehensive evaluation by a health care professional. Symptoms must be shown to be chronic, impair functionality and prevent typical development.