Clinical Trial

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

Study acronym: eTNS CARES
Recruiting
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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)
Trial Details
NCT Number NCT07214545
Lead Sponsor University of California, San Francisco
Conditions Attention Deficit Disorder With Hyperactivity (ADHD), Autism Spectrum Disorder (ASD)
Enrollment 60 participants
Start Date 2025-10-06
Primary Completion 2027-09 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-09