Drug-Free ADHD Therapy for Kids – Backed by Science, Cleared by the FDA
Overnight trigeminal nerve stimulation that significantly improves ADHD symptoms in children 7-12 – while avoiding drug-related side-effects like appetite loss or insomnia.¹ ²
Rx Only - Indicated for pediatric ADHD monotherapy, ages 7-12
A New Solution for ADHD
Many parents are hesitant to start their young children on stimulant medications due to side effects or stigma.
Now you can offer an alternative: Monarch eTNS®, a noninvasive neuromodulation therapy developed at UCLA and funded by NIH, which helps regulate key brain regions linked to ADHD – without medication.
Non-Pharmacological: Uses mild nerve stimulation instead of drugs.
At-Home Use: Administered by caregivers during sleep – no clinic visits or monitoring required.
Proven Efficacy: Significant symptom improvement in 4 weeks¹ ² (per clinical trial)
Minimal Side Effects: No serious adverse events, only mild transient effects¹ ² (e.g. drowsiness)
How Does Monarch eTNS Work?
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Monarch eTNS® gently stimulates the trigeminal nerve (via a small patch on the forehead) overnight.
The trigeminal nerve connects to brain regions involved in attention, emotion, and behavior.
fMRI and EEG studies show that eTNS increases activity in these frontal brain regions, helping to recalibrate networks that are dysregulated in ADHD. The working theory is improved regulation of prefrontal cortex activity.
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Discreet Apple TV sized stimulator connects to a disposable forehead patch.
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Delivers low-level electrical pulses to branches of the trigeminal nerve for 8 hours during sleep.
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Sensation is a mild tingling; children sleep through treatment comfortably.
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Use nightly; remove patch in the morning.
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Requires caregiver oversight (apply patch, turn device on/off).
Clinical Results: Proven Efficacy & Tolerability
Robust clinical data—from pilot feasibility work through a pivotal, sham-controlled trial—demonstrate that Monarch eTNS® delivers meaningful, drug-free symptom relief for children with ADHD.
8-Week Open-Label Pilot Study
(n = 24, ages 7-14)¹
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100 % nightly compliance; no withdrawals for adverse events
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ADHD-RS-IV total score fell 47 % by Week 8
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64 % of children were rated “much improved” or “very much improved” on the CGI-I after 4 weeks; 71 % reached that level at Week 8
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Reported side-effects were mild, transient, and did not require discontinuation
Randomized, Double-Blind, Sham-Controlled Trial (n = 62, ages 8-12)²
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After 4 weeks of monotherapy, the active eTNS group achieved a statistically significant reduction in ADHD-RS-IV versus sham (baseline-adjusted Δ ≈ –5 points; P < 0.05)
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Quantitative EEG revealed frontal network modulation in the active group only, supporting a neurophysiologic mechanism of action
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When treatment stopped, symptom scores in both groups rose, yet remained lower in the active arm, indicating residual benefit
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No serious or device-related adverse events occurred; safety mirrored the pilot study
Key Take-away: Nightly trigeminal nerve stimulation delivers clinically meaningful ADHD symptom relief within four weeks, with amplified gains by eight weeks and an excellent tolerability profile—providing physicians a non-pharmacologic, FDA-cleared option for first-line pediatric ADHD management.
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.
Parent of a 9-year-old boy with ADHD (Monarch eTNS® user)
"After just two weeks using the Monarch eTNS® at night, I noticed a huge improvement in my son’s focus and behavior. For the first time in years, we feel hopeful.”
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​Individual results may vary. Monarch eTNS®is indicated for pediatric ADHD (ages 7–12) as a standalone treatment; consult a physician to see if it’s right for your child.
How to Get Monarch eTNS for Your Patients
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Monarch eTNS® is expected to be commercially available in 2026.
In the meantime, you can prepare to offer it by:
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Joining our HCP waitlist to receive product availability updates and training resources;
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Downloading the Physician Info Kit (includes prescribing information, patient selection guide, and insurance support details).
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Once launched, Monarch eTNS® will be prescription-only, dispensed through specialty pharmacies or directly by the manufacturer’s program.
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Our team will assist with insurance verification and fulfillment to your patients’ families.
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Frequently asked questions
Important Safety Information:​
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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.”
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​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.
© 2025 NeuroSigma, Inc. All rights reserved.
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All rights reserved. Monarch eTNS® is a prescription-only medical device. See Important Safety Information and Instructions for Use.
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