FDA clears commercialization of first medical device for ADHD treatment

The Food and Drug Administration (FDA) has authorized the marketing of the first medical device indicated in the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The Monarch External Trigeminal Nerve Stimulation System (NeuroSigma) is approved for patients 7 to 12 years of age who are not treated with ADHD medications; the device is designed to be used at home under the supervision of a health care provider during periods of sleep. Monarch eTNS works by sending a low-level electrical pulse to the trigeminal nerve via a small patch placed on the patient's forehead.

The safety and effectiveness of the device have been evaluated in a clinical trial involving 62 children with ADHD of moderate to severe intensity. Patients were randomized to the eTNS device or placebo device for 4 weeks. The primary endpoint of the study was the improvement in the scale of badessment of ADHD administered by clinicians (ADHD-RS), a higher score indicating a worsening of symptoms.

The results showed that treatment with eTNS resulted in a statistically significant improvement in ADHD symptoms compared to placebo (eTNS: ADHD-RS score decreased by 34.1 points to 23.4 points; ADHD-RS decreased by 33.7 points to 27.5 points). In terms of safety, drowsiness, increased appetite, sleep disturbance, pinching of teeth, headache, and fatigue were the most common side effects badociated with treatment. ETNs.

The eTNS device should not be used in patients with active implantable pacemakers or implantable neurostimulators, or those with body-worn devices (ie, insulin pumps); It must not be used in the presence of radio frequency energy, as with MRI or mobile phones.

"This new device provides a safe and non-drug option for the treatment of ADHD in pediatric patients through light nerve stimulation, a first of its kind," said Carlos Peña, PhD, director of Physical Medicine Devices Division and neurological. in the FDA Center for Devices and Radiological Health.

For more information, visit neurosigma.com.

This article originally appeared on MPR