Nightly external trigeminal nerve stimulation to reduce ADHD symptoms in children with autism
Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder
NA · University of California, San Francisco · NCT07214545
This trial will test whether a small, nightly forehead patch that delivers external trigeminal nerve stimulation can reduce ADHD symptoms in children with autism.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 7 Years to 14 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07214545 on ClinicalTrials.gov |
What this trial studies
Children with clinician-confirmed autism and ADHD are randomly assigned to nightly active or sham external trigeminal nerve stimulation for about 8–12 weeks, with the option to try the active device later if they start on sham. Participation involves 4–5 in-person visits at UCSF plus four brief virtual check-ins, and nightly use of a small adhesive patch on the forehead while sleeping. Outcome measures include change in ADHD symptom scores, measures of core and associated autism features, cognitive testing, and tolerability/safety monitoring. The trial is designed as a randomized, blinded comparison of active versus sham stimulation to separate device effects from placebo and to gather short-term efficacy and safety data.
Who should consider this trial
Good fit: Ideal candidates are children with a clinician-confirmed DSM-5 diagnosis of autism, IQ above 70, a confirmed DSM-5 ADHD diagnosis with an ADHD-RS score over 24, stable medications for at least four weeks, and fluency in English for both child and caregiver.
Not a fit: Children with lower intellectual functioning (IQ ≤ 70), unstable major psychiatric conditions (for example current major depression, psychosis, or bipolar disorder), inability to tolerate or use the adhesive forehead device, or who cannot attend UCSF visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could provide a non-medication option that reduces ADHD symptoms and may improve some autism-related behaviors for some children.
How similar studies have performed: Earlier small trials of external trigeminal nerve stimulation have shown symptom improvements in pediatric ADHD, but evidence specifically in children with co-occurring autism is limited and still emerging.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- UCSF Nancy Friend Pritzker Psychiatry Building — San Francisco, California, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Attention Deficit Disorder With Hyperactivity, Autism Spectrum Disorder, eTNS, external trigeminal nerve stimulation, eTNS CARES