NCT07214545

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Oct 2025Jan 2028

First Submitted

Initial submission to the registry

September 11, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

October 6, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

September 11, 2025

Last Update Submit

October 7, 2025

Conditions

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

Keywords

eTNSexternal trigeminal nerve stimulationeTNS CARES

Outcome Measures

Primary Outcomes (1)

  • Change in ADHD Symptoms

    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.

    Baseline to end of treatment at 6 weeks

Secondary Outcomes (3)

  • Change in Social Responsiveness

    Baseline to end of treatment at 6 weeks

  • Change in Restricted and Repetitive Behaviors

    Baseline to end of treatment at 6 weeks

  • Change in Sleep Quality

    Baseline to end of treatment at 6 weeks

Study Arms (2)

Active eTNS Device

ACTIVE COMPARATOR
Device: Trigeminal Nerve Stimulation

Sham eTNS Device

SHAM COMPARATOR
Device: Sham Trigeminal Nerve Stimulation

Interventions

Trigeminal Nerve StimulationDEVICE

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

Active eTNS Device
Sham Trigeminal Nerve StimulationDEVICE

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

Sham eTNS Device

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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 may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, 94107, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersChild Development Disorders, Pervasive

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Vice Chair for Research-Child, Moghadam Family Distinguished Professor

Study Record Dates

First Submitted

September 11, 2025

First Posted

October 9, 2025

Study Start

October 6, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

October 9, 2025

Record last verified: 2025-10

Locations

US(1)