Los Angeles-based company NeuroSigma has announced it has received FDA approval for its Monarch External Trigeminal Nerve Stimulation (Monarch eTNS) device to treat children suffering from Attention Deficit Hyperactivity Disorder (ADHD).
The device is the first of its kind, offering non-surgical treatment in children aged 7 to 12 years who are not taking prescription drugs to treat the condition.
Monarch eTNS works by delivering a mild electrical shock to the nervous system via the trigeminal nerve, which directs signals to parts of the brain associated with ADHD. A patch and a small wire is attached to the patient’s forehead and delivers a tingling sensation to the skin – an effect of the low-level nerve stimulation.
During the clinical study, 32 children with ADHD used the Monarch eTNS device every night, and 30 children with ADHD used a placebo device. Those treated with the system experienced a significant improvement in symptoms in comparison to those that were treated with a placebo. 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.
“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,” says Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA's Centre for Devices and Radiological Health.
There have been no serious adverse effects associated with the device, with the most common side effects being drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue.
Monarch previously secured the EU CE Mark for the treatment of epilepsy and major depressive disorder.