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RECRUITING
NCT07214545
NA

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

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

7 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-06

Completion Date

2028-01-31

Last Updated

2025-10-09

Healthy Volunteers

No

Interventions

DEVICE

Trigeminal Nerve Stimulation

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

DEVICE

Sham 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