RecruitingNot ApplicableNCT07214545

External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms

Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder


Sponsor

University of California, San Francisco

Enrollment

60 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD). It will also learn about the efficacy and tolerability of the eTNS device. The main questions it aims to answer are: * Does eTNS reduce ADHD symptoms? * Does eTNS improve core and associated features of ASD? Participation spans 8-12 weeks and includes: * 4-5 in-person visits * 4 brief virtual check-ins * Nightly use of the eTNS device with a small sticky patch applied to child's forehead * Randomized assignment (those who start with the sham device may try the active device later)


Eligibility

Min Age: 7 YearsMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sham Trigeminal Nerve Stimulation and a medical device called Trigeminal Nerve Stimulation for people with attention deficit disorder with hyperactivity (adhd) and autism spectrum disorder (asd). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETrigeminal Nerve Stimulation

This intervention is expected to have an effect following a treatment period of 6 weeks.

DEVICESham Trigeminal Nerve Stimulation

This intervention is NOT expected to have an effect following a treatment period of 6 weeks.


Locations(1)

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, United States

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NCT07214545


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