Monarch eTNS: Non-Medication Prescription Device for ADHD
The Monarch eTNS device is a digital therapy for children with ADHD ages 7 to 12 that sends low stimulating pulses to the trigeminal nerve through a disposable patch placed on a child’s forehead at bedtime.
What Is Monarch eTNS?
Monarch eTNS is a non-medication prescription device designed for overnight use in children with ADHD ages 7 to 12. The Monarch eTNS System is the first FDA-cleared device for ADHD with proven efficacy in alleviating ADHD symptoms, according to a small study.1
How Does Monarch eTNS Work?
The Monarch eTNS (external Trigeminal Nerve Stimulation) System is an electronic device, about the size of a cell phone, that connects to a disposable patch placed on a child’s forehead at bedtime. Once turned on, the device sends low stimulating pulses to the trigeminal nerve through the patch overnight. The trigeminal nerve is the brain’s largest cranial nerve responsible for communicating sensations from the face to other parts of the nervous system — including brain areas involved in mood disorders, epilepsy, and attention.
Who Can Use Monarch eTNS?
Monarch eTNS is for patients ages 7 to 12 who are not currently taking prescription ADHD medication. The device should not be used by patients with an active implantable pacemaker or implantable neurostimulator, or in those with body-worn devices (e.g., insulin pumps).
What Studies Have Been Done on Monarch eTNS?
Two clinical trials compared the Monarch eTNS system’s efficacy in treating ADHD to a placebo device.
In 2014, 24 children with ADHD aged 7-14 years participated in an 8-week, open-label pilot feasibility study. After four weeks of nightly use, the Clinical Global Impression–Improvement (CGI-I) scale rated 64% of the study group as “improved” or “improved very much.” This trial showed a 47% decrease in the ADHD Rating Scale IV (ADHD-RS-IV) score and a responder rate of 71% on the Clinical Global Impressions Scale-Improvement (CGI-I) scale after eight weeks. Trial participants used the treatment as directed, side effects were minimal, and no child withdrew from the study due to adverse events, according to results published in Brain Stimulation.1
A team of UCLA researchers published the results of the first double-blind, placebo-controlled trial examining the efficacy of the Monarch eTNS on ADHD in children in the Journal of the American Academy of Child and Adolescent Psychiatry in 2018. They concluded that more than half of the children (52%) who used the Monarch at bedtime for four weeks—under parent supervision—experienced significantly reduced impulsivity, hyperactivity, and inattention, as measured by clinician-administered ADHD rating scales compared to the placebo group (14%).
What Are the Side Effects of Monarch eTNS?
The most common side effects observed with eTNS included drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. No serious adverse events were associated with device use.
Where Can I Learn More About Monarch eTNS?
You can learn more about Monarch eTNS at https://www.monarch-etns.com/.
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1</supMcGough, J.J., Loo, S.K., Sturm, A., et al. (2015). An Eight-Week, Open-Label Pilot Feasibility Study of Trigeminal Nerve Stimulation in Youth with Attention-Deficit/Hyperactivity Disorder. Brain Stimulation. 8:299-304. https://doi.org/10.1016/j.brs.2014.11.013
2</supMcGough, J.J., Sturm, A., Cowen, J., et al. (2019). Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 58(4):403-411. https://doi.org/10.1016/j.brs.2014.11.013
