The Science Behind Monarch eTNS®
You want to see the data. We get it. When it comes to your child's health, "trust us" isn't enough.
Here's the scientific clinical evidence behind Monarch eTNS® — the research that supported FDA clearance — explained in clear and easy to understand terms.
Rx Only - Indicated for pediatric ADHD monotherapy, ages 7-12
We Know You're Doing Your Homework
You've probably spent hours researching ADHD treatments. You've read about medications, their side effects, behavioral therapy, diet changes — and now you're here, looking into something that sounds almost too good to be true. A device that works while your child sleeps?
We don't expect you to take our word for it. That's why Monarch eTNS® underwent rigorous clinical testing at UCLA before the FDA cleared it as the first non-drug, device-based treatment for pediatric ADHD.
Real kids. Real doctors. Real results.
Let's walk through what the researchers found.
Important: Monarch eTNS® is approved for children ages 7-12 who are not currently taking prescription ADHD medication.
THE THREE SCIENTIFIC STUDIES AT A GLANCE
Study 1: Initial Feasibility Study (2015)
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Type: Open-label feasibility study
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Duration: 8 weeks
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Participants: 24 children, ages 8-12
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Purpose: Test safety and whether the approach was worth pursuing
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Published in: Brain Stimulation
🎧 Listen & Learn:
Prefer to listen? Hear a deep dive, parent-friendly podcast that walks through this published study —
how the research was done, what scientists observed, and what it means in simple terms.
For educational purposes only. Not medical advice.
Study 2: Pivotal FDA Trial (2019)
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Type: Double-blind, sham-controlled trial
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Duration: 4 weeks
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Participants: 62 children, ages 7-12
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Purpose: Definitively test whether it works
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Published in: Journal of the American Academy of Child & Adolescent Psychiatry
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This study supported FDA clearance
🎧 Listen & Learn:
Prefer to listen? Hear a deep dive, parent-friendly podcast that walks through this published study —
how the research was done, what scientists observed, and what it means in simple terms.
For educational purposes only. Not medical advice.
Study 3: Understanding Response (2021)
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Type: Analysis of who responded to treatment
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Purpose: Explore patterns in treatment response
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Published in: Journal of the American Academy of Child & Adolescent Psychiatry
🎧 Listen & Learn:
Prefer to listen? Hear a deep dive, parent-friendly podcast that walks through this published study —
how the research was done, what scientists observed, and what it means in simple terms.
For educational purposes only. Not medical advice.
These audio summaries are educational discussions of published, peer-reviewed studies on trigeminal-nerve stimulation and ADHD.
They do not provide medical advice or product recommendations.
Always consult your child’s healthcare provider before making decisions about diagnosis or treatment.
The Pilot Study
🎧 Prefer to listen? Parent-friendly podcast on this article.
An eight-week, open-label pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder.
https://pubmed.ncbi.nlm.nih.gov/25
In 2015, researchers at UCLA wanted to see if trigeminal nerve stimulation could help kids with ADHD. They recruited 24 children (ages 8-12) who weren't taking any ADHD medication and had them use the Monarch device every night for 8 weeks.
Parents applied the forehead patch at bedtime, turned on the device, and let it run while their kids slept. That's it. No pills, no clinic visits, no complicated protocols.
What They Measured
Doctors and parents filled out standardized ADHD rating scales (called ADHD-RS-IV) each week — the same tests used to measure how well medications work.
They were looking for changes in:
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Inattention (trouble focusing, easily distracted)
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Hyperactivity (can't sit still, excessive talking)
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Impulsivity (interrupting, acting without thinking)
What They Found
Symptom Improvement:
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After just 4 weeks: 64% of kids were rated "much improved" or "very much improved" by their doctors
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By week 8: That number rose to 71%
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ADHD symptom scores dropped by 47% over the 8 weeks
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Parents noticed improvements at home; teachers noticed improvements at school
Safety:
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Zero serious side effects
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All 24 kids completed the study
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Some experienced mild, temporary effects like morning drowsiness or headache
What This Study Showed:
This first study demonstrated that the device was safe, well-accepted by families, and showed promising results. Because everyone in the study knew they were getting the real device (called an "open-label" study), the next step was to test it against a placebo in a more rigorous trial.
The FDA Pivotal Trial
🎧 Prefer to listen? Parent-friendly podcast on this article.
Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder
https://pubmed.ncbi.nlm.nih.gov/30768393/
After the promising pilot results, researchers designed a rigorous test to definitively answer: Does Monarch eTNS® actually work, or were improvements in the first study due to placebo effects?
They recruited 62 children (ages 7-12) with ADHD who weren't taking medication. Half got the real Monarch device, and half got a "sham" device that looked and felt identical but didn't actually stimulate the nerve.
Here's the clever part: Neither the families nor the doctors knew who had which device. Everyone went through the exact same routine — applying the patch, turning on the device, sleeping with it on. They used it every night for 4 weeks, then stopped for a week to see what happened.
What They Measured
Primary outcome:
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ADHD Rating Scale (ADHD-RS) total score — completed weekly by doctors based on parent interviews
Secondary outcomes:
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Clinical Global Impression (CGI-I) — doctor's rating of overall improvement
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Parent behavior ratings
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Brain activity measured by EEG (brain wave tests)
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Side effects and safety
What They Found
Symptom Improvement:
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After just 4 weeks: 64% of kids were rated "much improved" or "very much improved" by their doctors
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By week 8: That number rose to 71%
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ADHD symptom scores dropped by 47% over the 8 weeks
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Parents noticed improvements at home; teachers noticed improvements at school
What This Study Showed:
ADHD Symptoms:
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Kids with the real device had significantly bigger drops in ADHD scores than the sham group
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Both groups improved a bit in week 1 (likely from increased attention and routine), but only the active group kept improving
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Statistical significance: p = .005 (meaning the results were very unlikely to be due to chance)
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Effect size: Cohen's d = 0.5 (similar to non-stimulant ADHD medications)
Clinical Improvement:
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52% showed major improvement with the real device (rated "much improved" or "very much improved")
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Only 14% showed similar improvement with the sham device
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Number needed to treat: 3 (for every 3 kids treated, 1 additional child improves compared to sham)
Brain Changes:
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Real device: Increased activity in the right frontal brain region — the area responsible for attention and impulse control
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Sham device: No brain changes at all
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This proved the device was actually doing something to the brain, not just making people feel better
After Stopping:
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Symptoms started creeping back up in both groups after treatment stopped
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BUT: Kids who'd used the real device still had lower symptoms than the sham group, suggesting some lasting effect
Safety:
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Zero serious side effects
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Every single child completed the study
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Mild side effects: drowsiness (22%), increased appetite (19%), fatigue (13%), headache (13%)
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Nothing that made anyone quit
This is the study that convinced the FDA to clear Monarch eTNS® as the first non-drug, device-based treatment for pediatric ADHD.
Understanding Who Responds
🎧 Prefer to listen? Parent-friendly podcast on this article.
Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder: Cognitive and
Electroencephalographic Predictors of Treatment Response
https://pubmed.ncbi.nlm.nih.gov/33068751/
About half the kids in Study #2 had great results. The other half? Not so much. Researchers wanted to know: What made the difference?
They went back through all the data from Study #2 — brain scans, cognitive tests, behavior ratings — and looked for patterns between the 25 kids who responded and the 26 who didn't.
What They Measured
At baseline (before treatment):
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Executive function ratings by parents (BRIEF scale)
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Achievement test scores (reading, spelling, math)
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Computerized cognitive tests
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Brain electrical activity (EEG) patterns
After treatment:
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Changes in brain activity
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Changes in executive function ratings
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How these changes related to ADHD symptom improvement
What They Found
Kids who responded to treatment had something in common: They struggled with executive function — the brain's "control center" skills like:
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Remembering instructions (working memory)
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Planning ahead
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Staying organized
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Starting tasks without procrastinating
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Thinking before acting
At baseline, responders had:
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Higher scores on the BRIEF Working Memory scale (meaning more difficulty)
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More challenges with planning and organization
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Lower achievement test scores
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Lower brain activity in the right frontal region
Brain Changes:
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Responders showed increased right frontal brain activity after 4 weeks
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Non-responders showed no brain changes
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The amount of brain activity increase correlated with symptom improvement
Executive Function Improvements:
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Responders showed big improvements in working memory, planning, and organization skills
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These improvements happened alongside ADHD symptom reduction
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Non-responders showed minimal change
The Strongest Predictor:
The BRIEF Working Memory scale predicted treatment response better than any other measure, with 83% accuracy in this group.
Important Context:
This was exploratory research — meaning it identified interesting patterns but needs confirmation in future studies. While the findings are promising, they cannot predict individual response right now.
Approximately half of children responded to treatment across various baseline characteristics. If your child has executive function challenges, they may be more likely to benefit, but this needs more study before it can be used clinically.
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Important Safety Information:
Indication: Monarch eTNS® System is indicated for treatment of pediatric ADHD as a monotherapy in patients ages 7 to 12 who are not currently on prescription ADHD medications. The device is for use during sleep under the supervision of a caregiver.
Contraindications: Not for use in patients with implanted pacemakers, neurostimulators, or metallic/electronic head implants. Do not use in children under 7.
Common side effects: Drowsiness, increased appetite, insomnia, teeth clenching, headache, fatigue. Rx Only. Please refer to the Instructions for Use or contact us for full safety information.”
For full Indication, Contraindications and Important Safety Information see the detailed labeling
or contact Medical Affairs at (310) 479-3100.
References:
1. McGough JJ, Loo SK, Sturm A, et al. An eight-week, open-label pilot feasibility study of trigeminal
nerve stimulation in youth with attention-deficit/hyperactivity disorder. Brain Stimulation. 2015;8:299-304.
2. McGough JJ, Sturm A, Cowen J, et al. Double-blind, sham-controlled, pilot study of trigeminal nerve stimulation for attention deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2019;58(4):403-411.
3. Loo SK, Salgari GC, Ellis A, et al. J Am Academy of Child Adolescent Psychiatry. 2021;60(7):856-864.
See full safety information in the Instructions for Use.
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All rights reserved. Monarch eTNS® is a prescription-only medical device. See Important Safety Information and Instructions for Use.