An interventional study of Trigeminal Nerve Stimulation and Sham Trigeminal Nerve Stimulation in Attention Deficit Disorder With Hyperactivity (ADHD) and Autism Spectrum Disorder (ASD), sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 7 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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:
Participation spans 8-12 weeks and includes:
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Trigeminal Nerve Stimulation
Device: Sham Trigeminal Nerve Stimulation
This intervention is expected to have an effect following a treatment period of 6 weeks.
This intervention is NOT expected to have an effect following a treatment period of 6 weeks.
Change in ADHD Symptoms
Examine the efficacy of external Trigeminal Nerve Stimulation (eTNS) in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5; range 0-54), where higher scores indicate worse symptoms.
Time frame: Baseline to end of treatment at 6 weeks
Change in Social Responsiveness
Examine changes in social communication and related behaviors as measured by the Social Responsiveness Scale, Second Edition, Short Form (SRS-2-SF; range 0-48), where higher scores indicate worse impairment.
Time frame: Baseline to end of treatment at 6 weeks
Change in Restricted and Repetitive Behaviors
Examine changes in restricted and repetitive behaviors as measured by the Repetitive Behavior Scale-Revised (RBS-R; range 0-129), where higher scores indicate more severe repetitive behaviors.
Time frame: Baseline to end of treatment at 6 weeks
Change in Sleep Quality
Examine changes in sleep quality as measured by the Children's Sleep Habits Questionnaire (CSHQ; range 33-99), where higher scores indicate poorer sleep quality.
Time frame: Baseline to end of treatment at 6 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Attention Deficit Disorder with Hyperactivity→
University of California, San Francisco