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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07214545
Status
Recruiting
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Conditions

  • Attention Deficit Disorder With Hyperactivity (ADHD)
  • Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex
ALL
Age
7 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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)

Key Dates

Start date
Oct 6, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active eTNS Device
  • Sham Comparator: Sham eTNS Device

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Nancy Friend Pritzker Psychiatry BuildingSan FranciscoCalifornia94107
Jazzy Benes, MS
[email protected]
4154768803
James McCracken, MD (PRINCIPAL_INVESTIGATOR)

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UCSF Nancy Friend Pritzker Psychiatry Building· San Francisco, CA

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