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

NCT ID: NCT07214545

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-06
• Study Completion Date: 2028-01-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active eTNS Device

Group Type: ACTIVE_COMPARATOR

Trigeminal Nerve Stimulation

Intervention Type: DEVICE

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

Sham eTNS Device

Group Type: SHAM_COMPARATOR

Sham Trigeminal Nerve Stimulation

Intervention Type: DEVICE

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

Interventions

Trigeminal Nerve Stimulation

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

Intervention Type: DEVICE

Sham Trigeminal Nerve Stimulation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

James T McCracken, M.D.

Deputy Vice Chair for Research-Child, Moghadam Family Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jazzy Benes, MS

Role: primary

jazzy.benes@ucsf.edu

4154768803

Other Identifiers

25-44041

Identifier Type: -

Identifier Source: org_study_id