The Monarch eTNS® System is the First FDA Cleared Device for Treating Pediatric ADHD.

A family smiling and hugging behind a monarch etns system device

The Monarch eTNS System is indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment 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.

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Latest News

April 30, 2025 NeuroSigma Announces New Clinical Trial of Monarch eTNS System for Treatment of ADHD in Children with Fetal Alcohol Syndrome at UCLA

January 22, 2025 NeuroSigma Announces Patent Application Protecting Use of Trigeminal Nerve Stimulation to Include Treatment of Dyslexia and Other Neurodevelopmental Disorders

January 13, 2025 Clinical Trial of NeuroSigma's Monarch eTNS System for ADHD at King's College London Completes Enrollment

December 11, 2024 New Clinical Trial of eTNS for Pediatric ADHD to Commence at Denmark's Center for Evidence-Based Psychiatry

May 09, 2024 NeuroSigma Announces Acceptance into 2024 Cohort of the KidsX Accelerator Program

January 18, 2024 NeuroSigma Announces FDA Clearance of its Second-Generation Monarch eTNS System for Treating Pediatric ADHD

November 07, 2023 NeuroSigma Announces FDA 510(k) Submission for Second Generation Monarch eTNS System

October 03, 2023 NeuroSigma Announces HSA Approval of the Monarch eTNS System in Singapore

July 12, 2023 NeuroSigma Establishes Singapore Subsidiary

March 01, 2023 NeuroSigma Announces New Telehealth Option for Patients and Caregivers Interested in eTNS for Pediatric ADHD

January 31, 2023 NeuroSigma Announces Strategic Digital Marketing Partnership with Data360

November 08, 2022 NeuroSigma Announces that Enrollment Commences in Two Large, Double-Blind Trials of eTNS for Pediatric ADHD

October 17, 2022 NeuroSigma Announces Commercial Launch of The Monarch eTNS® System for the Treatment of Pediatric ADHD at Annual Meeting of the American Academy of Child and Adolescent Psychiatry

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