Medical Device to Treat ADHD

FDA has announced the marketing of the first medical device called “Monarch External Trigeminal Nerve Simulation System” (eTNS) to treat Attention Deficit Hyperactivity Disorder (ADHD. The marketing permit has been granted to NeuroSigma and directed for use for patients’ ages 7 to 12 years old who are not currently taking prescribed ADHD medication.

ADHD symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and experience very high levels of activity. The diagnosis requires a comprehensive evaluation by a healthcare professional and the eTNS is to be used in the home under the supervision of a caregiver when the child with ADHD is asleep. .

The system delivers low level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. Neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion, and behavior.

The new system should not be used in children under seven years of age and should not be used in patients with an active implantable pacemaker, with active implantable neuro-stimulators, or with patients with devices worn on the body such as insulin pumps.

“This new device offers a safe, non-drug option to treating ADHD in pediatric patients through the use of mild stimulation” reports Carolos Pena, PhD, Director of the Division of Neurological and Physical Medicine Devices within FDA’s Center for Devices and Radiological Health.

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