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Monarch eTNS System® for Pediatric ADHD

Attention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed neurological conditions in school-age children that often persists into adulthood. Parents and caregivers looking for alternatives to ADHD medication have a new treatment option: The Monarch eTNS (external Trigeminal Nerve Stimulation) System by NeuroSigma.

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Getting the Monarch eTNS System

The Monarch eTNS System is now available to patients and physicians through NeuroSigma’s Early Access Program. There are two ways to obtain a device.



If you would like to work with your existing doctor or healthcare professional, simply download our PATIENT INFORMATION FORM. This download contains the Monarch eTNS prescription form for you to share with your healthcare professional and step-by-step instructions on how to get the device.



You may also use our PHYSICIAN FINDER PAGE to locate one of our Early Access Program centers familiar with the Monarch eTNS System.

Candidates for Monarch eTNS Therapy In the United States, the Monarch is indicated for the treatment of pediatric ADHD as a standalone therapy (monotherapy) in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is available by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.



The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events have been associated with use of the device. Please consult the instructions for use for additional information.



For full safety information, please click here.

How the Monarch eTNS System Works The Monarch eTNS System includes a cellphone-sized device that sends a low-level electrical pulse through a wire to a small patch adhered to the patient's forehead. The therapeutic pulses stimulate the branches of the trigeminal nerve, which activates the neural pathway to other parts of the brain thought to be involved in ADHD. Neuroimaging studies have shown that eTNS increases activity in brain regions that are known to be important in regulating attention, emotion, and behavior.

Monarch eTNS Treatment The Monarch eTNS device should be used in the home under the supervision of a caregiver during periods of sleep. Each night at bedtime, the caregiver places the adhesive patch on the patient's forehead, just above the eyebrows. Patients describe the stimulation as a tingling sensation on the skin. Clinical trials suggest that a response to eTNS may take up to 4 weeks to become evident. The performance of the device was assessed compared to a sham (placebo) device based on improvement in ADHD-RS (an assessment for ADHD symptoms) after 4 weeks. The results of the main clinical study for the device showed that patients who were treated with the Monarch eTNS improved significantly more than patients who were treated with a sham (placebo) device. More information on the Monarch eTNS clinical studies is available in the device user manual. Patients should consult with their healthcare professional after 4 weeks of use to assess treatment effects.

How much does the Monarch eTNS System cost?



Frequently Asked Questions About the Monarch eTNS System

The price for the Monarch eTNS System starter kit is $980. The starter kit includes everything needed to begin therapy including the controller unit and a 4-week supply of electric patches. Refill electric patches are sold in packages of 7, which cost $70.



I have more questions about the Monarch, who can I contact?



Please download the Monarch eTNS order form for instructions on contacting NeuroSigma customer service.



The Monarch eTNS® System, the Monarch NS-2 Electric Patch, and related brand marks are trademarks of NeuroSigma, Inc.



No use of any NeuroSigma trademark, trade name, or trade dress in this site may be made without the prior written authorization of NeuroSigma, except to identify the product or services of the company. The product images are for illustrative purposes only.



The website and the information contained herein is intended for use by residents of the United States.



Why is the Monarch eTNS System used for children not taking ADHD medications?



For scientific study purposes, the studies that supported FDA clearance of the Monarch eTNS System for pediatric ADHD did not enroll children taking ADHD medications, so the safety and effectiveness of the device in children taking ADHD medication is unknown at this time. As a result, the FDA cleared the Monarch eTNS system only for patients not taking medication.



Can the Monarch eTNS System be used by adults with ADHD?



The Monarch eTNS System is FDA cleared for use in patients who are 7 to 12 years old, and who otherwise meet the intended use criteria. Currently, there have been no research studies involving adults with ADHD, so the safety and effectiveness of the device in treating adults with ADHD is unknown.



Will I be reimbursed for the Monarch eTNS System by my insurance?



Typically, new products approved for the treatment of ADHD are not immediately reimbursed by patients' insurance. NeuroSigma has partnered with Quick Care Pharmacy to handle prescriptions of the Monarch eTNS System. Patients with prescriptions can work with Quick Care to try and obtain coverage of the Monarch eTNS System via the prior authorization process. Additionally, patients who currently have a Health Savings Account (HSA) or Flexible Spending Account (FSA) may be able to use those funds to cover the cost of the device.



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Los Angeles, CA 90024

Phone: (310) 479-3100

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For Patients

For Physicians

FAQ

For Physicians NeuroSigma is pioneering the use of trigeminal nerve stimulation (TNS) neuromodulation therapies for a variety of neurological and neuropsychiatric disorders, including ADHD. Our research efforts are led by an experienced team of doctors, scientists, and engineers. Use of TNS as a therapeutic platform is supported by over a decade of both basic science and clinical studies, which include: Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder The first double-blind randomized controlled trial of external Trigeminal Nerve Stimulation (eTNS) for pediatric ADHD included 62 children ages 8 to 12 to use eTNS as monotherapy for 4 weeks. The trial demonstrated statistically significant improvements in symptoms of ADHD as measured by the ADHD-RS-IV scale among children randomized to the treatment group as compared to those in the sham group. The trial also found significant changes in quantitative EEG recordings among subjects randomized to the treatment group as compared to those in sham. Results were published in the Journal of the American Academy of Child and Adolescent Psychiatry in 2019. An Eight-Week, Open-Trial, Pilot Feasibility Study of Trigeminal Nerve Stimulation in Youth With Attention-Deficit/Hyperactivity Disorder This 8-week open trial included 24 participants ages 7 to 14 with ADHD who had TNS administered nightly during sleep. Participants were assessed weekly with parent- and physician-completed measures of ADHD symptoms and executive functioning as well as treatment compliance, adverse events, and side effects. Computerized tests of cognitive functioning were administered at baseline and weeks 4 and 8. Results were published in 2015 in the peer-reviewed medical journal Brain Stimulation.

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