External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms (eTNS CARES)

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Autism Spectrum Disorder (ASD)

Treatments

Device: Sham Trigeminal Nerve Stimulation

Device: Trigeminal Nerve Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT07214545

25-44041

Details and patient eligibility

About

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)

Enrollment

60 estimated patients

Sex

All

Ages

7 to 14 years old

Volunteers

No Healthy Volunteers

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