- August 27, 2019
The prescription-only treatment — NeuroSigma’s Monarch external trigeminal nerve stimulation system — is designed for children who are currently not taking any medications. About the size of a cellphone, the device delivers a mild electrical pulse to a wired patch placed on the patient’s forehead while sleeping. By stimulating the branches of the trigeminal cranial nerve, it is believed the system triggers therapeutic signals sent to the parts of the brain involved in ADHD, although the exact mechanism is not known. Neuroimaging studies have shown that eTNS increases brain activity in regions related to attention, emotion and behavior, according to the FDA.
“This new (medical) device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health (CDRH), which granted the device a de novo clearance [meaning that the FDA had determined that the medical device is a “novel” with no existing classification or predicate [previous] device(s) on the market].
In a placebo-controlled clinical trial of 62 children, the Monarch system demonstrated significant improvements in an ADHD symptom scale after four (4) weeks. According to the FDA, it may take at least one (1) month for the treatment to deliver a noticeable effect; after that time, caregivers should consult their providers to reassess the treatment.
While no serious adverse events were observed, the most common side effects were drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. The device should not be used in patients with implanted pacemakers or neurostimulators, nor wearable insulin pumps.
The Los Angeles-based NeuroSigma previously received a CE mark for its device in late 2015 for use in adults and children over age 7, representing the first non-drug ADHD treatment in the EU. The Monarch system has also received a CE mark in major depressive disorder in patients older than 9.
REFERENCE: Fierce BioTech; 22 APR 2019; Conor Hale