External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified September 2025 by University of California, San Francisco
Sponsor
University of California, San Francisco
Information Provided by (Responsible Party)
James T McCracken, M.D.
Clinicaltrials.gov Identifier
NCT07214545
Other Study ID Numbers:
25-44041
First Submitted
September 10, 2025
First Posted
October 8, 2025
Last Update Posted
October 8, 2025
Last Verified
September 2025

ClinicalTrials.gov processed this data on October 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Attention Deficit Disorder With Hyperactivity (ADHD)Autism Spectrum Disorder (ASD)
Device: Trigeminal Nerve StimulationDevice: Sham Trigeminal Nerve Stimulation

Study Design

Study TypeInterventional
Actual Enrollment60 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitlePhase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder
Study Start DateOctober 5, 2025
Actual Primary Completion Date1yr 3mos from now
Actual Study Completion Date1yr 8mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Active eTNS Device
Device: Trigeminal Nerve Stimulation
This intervention is expected to have an effect following a treatment period of 6 weeks.
Sham eTNS Device
Device: Sham Trigeminal Nerve Stimulation
This intervention is NOT expected to have an effect following a treatment period of 6 weeks.

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.
  2. 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.
  3. 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.

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsUniversity of California, San Francisco
Locations
UCSF Nancy Friend Pritzker Psychiatry Building | San Francisco California, United States, 94107