External Trigeminal Nerve Stimulation for Children with ASD + ADHD

This study is testing if external trigeminal nerve stimulation (eTNS) can help reduce ADHD symptoms in children aged 7 to 14 who have both Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD). Researchers want to see if eTNS reduces ADHD symptoms and improves other features of ASD. Participants will use an eTNS device at home nightly for 6 weeks. Success will be measured by changes in ADHD symptoms from the start to the end of this 6-week treatment period. The study plans to enroll 60 children, but its current recruitment status is unclear. To join, children must have a confirmed diagnosis of ASD and an IQ above 70.

Study design: This is an interventional study planning to enroll 60 participants. Participants will be randomly assigned to receive either active Trigeminal Nerve Stimulation or a sham (inactive) device.
What's involved: Participation lasts 8-12 weeks and includes 4-5 in-person visits, 4 brief virtual check-ins, and nightly use of the eTNS device with a small sticky patch on the forehead.
Compensation: Not stated in the trial record.
Follow-up: ADHD symptoms are measured at the end of the 6-week treatment period.

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

Recruiting

NAAges 7–14InterventionalTreatment

University of California, San Francisco

~60 participants

Updated 2025-10-09 on ClinicalTrials.gov

What's tested:Trigeminal Nerve StimulationSham Trigeminal Nerve Stimulation

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in ADHD Symptoms

Measured over Baseline to end of treatment at 6 weeks

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Autism Spectrum Disorder (ASD)

Where it's being run

1 sites across 1 states

California1

Who to contact

Jazzy Benes, MS

[email protected]

4154768803

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Do you actually qualify for this trial?

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Eligibility criteria

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 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

What this trial measures

Change in ADHD SymptomsBaseline to end of treatment at 6 weeks
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.

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