NCT07214545 External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
| NCT ID | NCT07214545 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Attention Deficit Disorder With Hyperactivity (ADHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-10-06 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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)
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Frequently Asked Questions
Who can join the NCT07214545 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 14 Years, studying Attention Deficit Disorder With Hyperactivity (ADHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07214545 currently recruiting?
Yes, NCT07214545 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of California, San Francisco to inquire about joining.
Where is the NCT07214545 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07214545 clinical trial?
NCT07214545 is sponsored by University of California, San Francisco. The trial plans to enroll 60 participants.