Tests a forehead nerve device for ADHD symptoms in autistic children
Tests a nightly forehead nerve device in autistic children with ADHD.
Plain-language title generated from the registry record
Registry title: External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
Key facts
- Where
- San Francisco, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 14 years old?
Source: NCT07214545, who can take part
Where in United States
- UCSF Nancy Friend Pritzker Psychiatry BuildingSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of California, San Francisco
- Trial code
- NCT07214545
- Record updated
- 20 October 2026
- Original description
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:Read full original descriptionShow less
Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder
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)
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 and anticipated continued use of antipsychotic or stimulant medication; 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; Presence of implanted stimulator (e.g., vagal nerve stimulator); Inability to communicate discomfort or pain.