FDA clears NeuroSigma’s Monarch device to treat ADHD

23 April 2019 (Last Updated April 23rd, 2019 11:13)

The US Food and Drug Administration has granted marketing clearance for Monarch, an external trigeminal nerve stimulation system developed by NeuroSigma, to treat attention deficit hyperactivity disorder.

FDA clears NeuroSigma’s Monarch device to treat ADHD
Monarch is a nerve stimulation device designed to generate and deliver electrical pulses to the trigeminal nerve. Credit: Pete Linforth from Pixabay.

The US Food and Drug Administration (FDA) has granted marketing clearance for Monarch, an external trigeminal nerve stimulation (eTNS) system developed by NeuroSigma, to treat attention deficit hyperactivity disorder (ADHD).

The device, which is indicated for patients aged 7-12 years who are not on prescription medication, is the first FDA-authorised non-drug treatment for ADHD.

Monarch is designed to generate and deliver electrical pulses to the trigeminal nerve, which directs signals to the parts of the brain that are believed to be associated with ADHD.

The device is connected to a small patch that adheres to a patient’s forehead. It is meant for at-home use during sleep and requires caregiver supervision.

Data from clinical trials showed that a response to eTNS may become evident in up to four weeks.

Commenting on the new device, FDA Division of Neurological and Physical Medicine Devices director Carlos Peña said: “This new device offers a safe, non-drug option for treatment of ADHD in paediatric patients through the use of mild nerve stimulation, a first of its kind.”

“This new device offers a safe, non-drug option for treatment of ADHD in paediatric patients through the use of mild nerve stimulation.”

The regulatory agency noted that the device proved its efficacy in treating ADHD in a trial that compared it to a placebo device. Conducted over four weeks, the trial enrolled a total of 62 children with moderate to severe ADHD.

Primary endpoint of the study was improvement on a clinician-administered ADHD Rating Scale (ADHD-RS), which tracks ADHD symptoms severity and frequency.

Patients treated with the Monarch eTNS system experienced a statistically significant improvement in their ADHD symptoms compared to subjects in the placebo arm.

At the end of week four, the average ADHD-RS score in the eTNS group was observed to decrease from 34.1 points at baseline to 23.4 points, while the decrease was 33.7 to 27.5 points in case of placebo.

The most common eTNS-related side effects during the trial were drowsiness, increase in appetite, difficulty in sleeping, teeth clenching, headache and fatigue. The trial did not find any serious adverse events.

Monarch previously secured the European CE-Mark to treat epilepsy and major depressive disorder, and Health Canada approval for drug-resistant epilepsy (DRE), major depressive disorder (MDD) and treatment-resistant depression.