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External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
Sponsor: University of California, San Francisco
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
Trigeminal Nerve Stimulation
This intervention is expected to have an effect following a treatment period of 6 weeks.
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