The Food and Drug Administration (FDA) announced the approval of a new medical device to treat attention-deficit hyperactivity disorder (ADHD) on April 19, 2019. This is the first time that a medical device to treat ADHD has been approved for use in the United States. The Monarch external Trigeminal Nerve Stimulation System, or the Monarch eTNS System for short, is intended primarily for children with ADHD between the ages of 7–12.

How The Device Works

The Monarch eTNS System is about the size of a cell phone and uses a small wire that attaches to the forehead. The wire sends weak electrical signals to the nerves located in the area near a specific group of nerves called the trigeminal nerves. These nerves send a therapeutic signal to the parts of the brain that are thought to cause ADHD symptoms. The Monarch eTNS System can be used at home and is typically operated at night during sleep. A clinical trial showed that the Monarch eTNS System was effective in treating ADHD symptoms and that it took about four weeks of therapy to become effective.

Approved Use in Children

The FDA reports that the Monarch eTNS System has been approved for marketing as a treatment for ADHD in the United States. This device is intended for use in children with ADHD between the ages of 7–12 who are not taking medication for their ADHD. The Monarch eTNS System is currently only approved for sale with a doctor’s prescription.

While the Monarch eTNS System is only approved for use in the United States for children with ADHD, it has been approved in Europe and Canada for treatment of depression and epilepsy. It is possible that, at some point, the Monarch eTNS System may be approved by the FDA for the treatment of these other conditions in the United States.

Possible Side Effects

During the clinical trial for the Monarch eTNS System, there were no serious side effects discovered. Potential side effects that were found during testing included:

  • Fatigue
  • Trouble sleeping
  • Teeth clenching
  • Headache
  • Increased appetite

These side effects are not likely to be dangerous, and treatment with the Monarch eTNS System is thought to be quite safe. While these side effects are currently the only significant side effects that have been discovered, the Monarch eTNS System is a relatively new technology, and it is possible that there may be other side effects that have not yet been discovered. Given the newness of this technology, it is also uncertain if there are any effects on long-term development in children.

One warning given by the FDA is that using the Monarch eTNS System near cell phones,  pacemakers, insulin pumps or other electronic devices should be avoided. This is because the Monarch eTNS System and these devices may interfere with each other.

How to Get Monarch eTNS

The Monarch eTNS System is sold exclusively by NeuroSigma and can only be purchased with a prescription. The device costs about $1000 and is not currently covered by insurance. Someone interested in obtaining or using a Monarch eTNS System should speak with their physician about the potential benefits of this device. If you have questions about the device or how to obtain it, you can contact NeuroSigma for more information.

What This Means for the Future of ADHD Treatment

Until the approval of the Monarch eTNS System, ADHD treatment had been highly dependent on behavioral therapy that could involve several visits to a therapist or physician over a long period and potentially addictive drugs. While still a new technology, the Monarch eTNS System may be an essential first step in getting away from the use of potentially addictive medications to treat ADHD and may help to promote more research and innovations for devices that can potentially be used for ADHD treatment.

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