The FDA approved the Monarch electronic Trigeminal Nerve Stimulation based on the findings of a trial involving children aged 7-12 years old.
The US Food and Drug Administration (FDA) has cleared the first non-drug therapy for the treatment of pediatric ADHD.
The Monarch electronic Trigeminal Nerve Stimulation (eTNS) device, a prescription monotherapy that sends mild electrical stimulations to trigeminal nerve branches, was granted marketing clearance by the FDA via the de novo pathway. The regulatory pathway indicates the device is a novel, low-to-moderate risk treatment.
The Monarch eTNS system was cleared for marketing based on the findings of a randomized, four-week clinical trial which assessed the device as a nightly therapy for 62 children aged 7-12 years old with moderate to severe ADHD. At the trial’s completion, treated patients reported a significant improvements on the ADHD Rating Scale IV (ADHD-RS-IV)—a metric commonly used in clinical trials involving ADHD therapies—compared to the control group (P= .005).
The investigators also reported statistically significant improvements in the treatment group compared to the control group in the Clinical Global Impressions 1 (CGI-1) scale (P= .003). Common side effects among eTNS-treated patients included drowsiness, appetite increase, trouble sleeping, clenched teeth, headache, and fatigue.
James J. McCough, MD, principal investigator of the trial and professor/psychiatrist at Jane & Terry Semel Institute for Neuroscience and Human Behavior at UCLA, praised the findings as indications of improved brain function in pediatric ADHD patients.
“"Treatment was well accepted by patients and families, compliance was high, and the results demonstrated a favorable safety profile for the device,” he said in a statement. “TNS has great potential as an additional option for managing ADHD.”
The eTNS system, from NeuroSigma, is designed to positively affect the trigeminal nerve—which is linked to specific regions of the brain involved in ADHD and other psychiatric disorders. Previous evidence shows that the mechanism of action associated with TNS is related to modulate activity in the targeted regions of the brain.
There was no word from NeuroSigma as to when the device will be available in US markets.
Ian Cook, MD, NeuroSigma's chief medical officer, said, "We look forward to launching eTNS in the United States and bringing this new treatment modality to children with ADHD."