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

a study on Attention-Deficit/Hyperactivity Disorder Autism

Summary

Eligibility
for people ages 7-14 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by James McCracken, MD (ucsf)

Description

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)

Official Title

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

Keywords

Attention Deficit Disorder With Hyperactivity (ADHD), Autism Spectrum Disorder (ASD), eTNS, external trigeminal nerve stimulation, eTNS CARES, Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder, Trigeminal Nerve Stimulation

Eligibility

You can join if…

Open to people ages 7-14

  • 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.

You CAN'T join if...

  • 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

Location

  • UCSF Nancy Friend Pritzker Psychiatry Building accepting new patients
    San Francisco 5391959 California 5332921 94107 United States

Lead Scientist at University of California Health

  • James McCracken, MD (ucsf)
    Professor, Psychiatry, School of Medicine. Authored (or co-authored) 286 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07214545
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated