FDA Approves New Device to Help Kids with ADHD

The U.S. Food and Drug Administration (FDA) has approved the first medical device to help children with attention-deficit/hyperactivity disorder (ADHD). The Monarch external Trigeminal Nerve Stimulation (eTENS) system is available for children with ADHD aged 7 to 12 who are not currently taking medication. The device offers the first non-drug treatment for the condition.

What is ADHD?

ADHD is a common condition that can be difficult to manage and begins in childhood. Symptoms of ADHD include difficulty focusing, inattention, impulse control issues, and increased physical activity. To be diagnosed with ADHD a person must demonstrate persistent inattention and hyperactivity that has a long-lasting effect and interferes with their daily life.

The eTENS System

The device requires a prescription and is intended to be used under the close supervision of a caregiver. It is about the size of a cell phone and is designed to generate a low-level electrical pulse to the trigeminal nerve from a wire to a small patch placed above the child’s eyebrows. The trigeminal nerve then sends therapeutic signals to the parts of the brain that are believed to affect ADHD. The child may feel a tingling sensation when the device is working. The device is intended to be used at home while the child is sleeping.

Clinical trials of the device have indicated that it may take up to four weeks to begin working properly. A test showed a significant improvement in ADHD symptoms for those patients who used the device for four weeks or more. Side effects of the device include drowsiness, increased appetite, and trouble sleeping. Long term side effects are not currently known because the device is so new. The device should not be used by children under the age of 7 or those that have pacemakers or active implantable neurostimulators.

The eTENS system is currently available in Canada, Australia, and Europe and has been used as a device to treat depression. No U.S. release date has been advertised yet. The system is not currently covered by insurance.

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