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First Medical Device To Treat ADHD Gets FDA Clearance


The first medical device to treat attention deficit hyperactivity disorder, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, has been given clearance by the FDA.

Developed by NeuroSigma Inc., a Los Angeles based medical device company, this prescription-only device is indicated for patients of ages 7 to 12 years who are not currently taking prescription attention deficit hyperactivity disorder (ADHD) medication.


ADHD is one of the most common neurodevelopmental disorders of childhood, whose symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. Although the exact cause of this disorder is not known, genetics is said to play an important role.

A combination of behavior therapy and medication is mostly recommended as a treatment for ADHD.

According to a report by the Centers for Disease Control and Prevention (CDC), 6.1 million American children were diagnosed with ADHD in 2016, compared to 4.4 million in 2003.

The Device

The Monarch eTNS system is a cell-phone sized device, composed of an external electric patch and a very low current external electric pulse generator.

The external electric patch is attached to a patient's forehead, just above the eyebrows, to safely stimulate branches of the trigeminal nerve through the skin. The electric patches are replaced daily for effective therapy and can be worn primarily in the evening while asleep, according to NeuroSigma.

The device can be used in the home under the supervision of a caregiver.

Monarch's efficacy in a trial

In a trial, a total of 62 children with moderate to severe ADHD were enrolled, and they were randomized to receive either the Monarch eTNS therapy each night or a placebo device at home for four weeks.

At the end of week four, the average ADHD Rating Scale score in the active group decreased from 34.1 points at baseline to 23.4 points, which was a statistically significant improvement, compared to a decrease from 33.7 to 27.5 points in the placebo group.

Side effects

Drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue are some of the side effects associated with the Monarch eTNS System. No serious adverse events have been observed with the use of the device.

The Monarch eTNS System should not be used in children under seven years of age. Patients with an active implantable pacemaker or with active implantable neurostimulators, or those using insulin pumps should not use this device.

Other regulatory approvals

The Monarch eTNS System received CE Mark approval for ADHD in the European Union in November 2015, and is also approved for the treatment of depression and epilepsy there.

The device is also approved in Canada for the treatment of epilepsy and depression, and in Australia for the treatment of epilepsy.

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