Recruiting

eTNS

Sponsor:

UCLA

Code:

NCT07214545

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex: All

Age: 7 - 14

Healthy Volunteers: Not accepted

Interventions

Trigeminal Nerve Stimulation

Sham Trigeminal Nerve Stimulation

Study Details

Brief summary:

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

Attention Deficit Disorder With Hyperactivity (ADHD)

Autism Spectrum Disorder (ASD)

Study ID

NCT07214545

Start date

Oct 6, 2025

Status verified date

Oct, 2025

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 14

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active eTNS Device

sham comparator: Sham eTNS Device

Interventions

Trigeminal Nerve Stimulation

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

Sham Trigeminal Nerve Stimulation

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

Primary outcome measure

  • Change in ADHD Symptoms [ Time Frame: Baseline to end of treatment at 6 weeks ]

Central Contacts and Locations

Locations

UCSF Nancy Friend Pritzker Psychiatry Building

Recruiting

San Francisco, California, United States, 94107

Contacts

Jazzy Benes, MS

4154768803jazzy.benes@ucsf.edu

Principal Investigator:

James McCracken, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

  • eTNS
  • external trigeminal nerve stimulation
  • eTNS CARES

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-10-09.