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Recruiting NCT07214545

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

No phase Interventional Attention Deficit Disorder With Hyperactivity (ADHD) Autism Spectrum Disorder (ASD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trigeminal Nerve Stimulation, Sham Trigeminal Nerve Stimulation.
Who it may be relevant to
Registry conditions: Attention Deficit Disorder With Hyperactivity (ADHD), Autism Spectrum Disorder (ASD). Basic parameters: 7 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

  • Device Trigeminal Nerve Stimulation
    This intervention is expected to have an effect following a treatment period of 6 weeks.
  • Device Sham Trigeminal Nerve Stimulation
    This intervention is NOT expected to have an effect following a treatment period of 6 weeks.

Primary outcome measures

  • Change in ADHD Symptoms [Time frame: Baseline to end of treatment at 6 weeks]
Secondary outcome measures (3)
  • Change in Social Responsiveness [Time frame: Baseline to end of treatment at 6 weeks]
  • Change in Restricted and Repetitive Behaviors [Time frame: Baseline to end of treatment at 6 weeks]
  • Change in Sleep Quality [Time frame: Baseline to end of treatment at 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCSF Nancy Friend Pritzker Psychiatry Building — San Francisco

Identifiers

NCT: NCT07214545 · 25-44041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗