Status:
RECRUITING
External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
Lead Sponsor:
University of California, San Francisco
Conditions:
Attention Deficit Disorder With Hyperactivity (ADHD)
Autism Spectrum Disorder (ASD)
Eligibility:
All Genders
7-14 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Confirmed clinician diagnosis of ASD according to DSM-5 criteria, corroborated by prior testing (or obtained in study screening) with the Autism Diagnostic Observation Schedule (ADOS) with or without the Autism Diagnostic Interview-Revised (ADI-R)
- IQ \> 70 as corroborated by prior testing (or obtained in study screening) with the Wechsler Abbreviated Scale of Intelligence Scale (WASI)
- Confirmed diagnosis of ADHD according to DSM-5 criteria with minimum ADHD-RS score of \> 24
- Stable on current medications for a minimum of 4 weeks before baseline
- Ability to complete protocol testing
- Both the child participant and their primary caregiver must be fluent in English (speaking, reading, and understanding), as the questionnaires and assessment tools used in this study have been validated only in English.
Exclusion
- Current major depression, history of psychosis, bipolar disorder, elevated risk of self-harm
- History of moderate to severe coarse brain injury
- Active medical illness expected to interfere with study assessments
- Presence of implanted stimulator (e.g., vagal nerve stimulator)
- Active dermatologic condition likely to interfere with eTNS electrode wearability
- Sleep disorder likely to interfere with nightly eTNS in the opinion of the study physician
- Inability to communicate discomfort or pain
- Current and anticipated continued use of antipsychotic or stimulant medication
Key Trial Info
Start Date :
October 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07214545
Start Date
October 6 2025
End Date
January 31 2028
Last Update
October 9 2025
Active Locations (1)
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1
UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, California, United States, 94107