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NCT Number: NCT07214545

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

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)

Recruiting

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Autism Spectrum Disorder (ASD) Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, 94107, United States

Location status: Recruiting

Location contact

James McCracken, MD

PRINCIPAL_INVESTIGATOR

Jazzy Benes, MS

CONTACT

[email protected]

4154768803

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trigeminal Nerve Stimulation

Device

This intervention is expected to have an effect following a treatment period of 6 weeks.

Sham Trigeminal Nerve Stimulation

Device

This intervention is NOT expected to have an effect following a treatment period of 6 weeks.

Primary outcomes

  1. Change in ADHD Symptoms

    Time frame: Baseline 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.

Secondary outcomes

  1. Change in Social Responsiveness

    Time frame: Baseline to end of treatment at 6 weeks

    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

    Time frame: Baseline to end of treatment at 6 weeks

    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

    Time frame: Baseline to end of treatment at 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder

Acronym: eTNS CARES

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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