Nightly external trigeminal nerve stimulation to reduce ADHD symptoms in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UCSF Nancy Friend Pritzker Psychiatry Building
  San Francisco, California, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.