Actively Recruiting
External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
Led by University of California, San Francisco · Updated on 2025-10-09
60
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of autism spectrum disorder (ASD) according to DSM-5 and testing with ADOS with or without ADI-R
- IQ greater than 70 confirmed by prior or study testing with WASI
- Confirmed ADHD diagnosis according to DSM-5 with ADHD-RS score over 24
- Stable on current medications for at least 4 weeks before baseline
- Ability to complete study testing procedures
- Child and primary caregiver must be fluent in English (speaking, reading, understanding)
You will not qualify if you...
- Current major depression, history of psychosis, bipolar disorder, or elevated risk of self-harm
- History of moderate to severe brain injury
- Active medical illness expected to interfere with assessments
- Presence of implanted stimulators such as vagal nerve stimulator
- Active skin condition likely to interfere with eTNS electrode wear
- Sleep disorder likely to interfere with nightly eTNS as judged by study physician
- Inability to communicate discomfort or pain
- Current or planned continued use of antipsychotic or stimulant medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, California, United States, 94107
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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