NCT07214545Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- 6 Oct 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- University of California, San Francisco
- Diseases
- Autism
- NCT number
- NCT07214545
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 6 Oct 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current and anticipated continued use of antipsychotic or stimulant medication
Other illness
- 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
- 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
Other
- Presence of implanted stimulator (e.g., vagal nerve stimulator)
- Inability to communicate discomfort or pain
Who the study is looking for
- 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.
Age in the registry: 7 years to 14 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCSF Nancy Friend Pritzker Psychiatry Building Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.