Attention Deficit Disorder With Hyperactivity (ADHD), Autism Spectrum Disorder (ASD)
Conditions
Keywords
eTNS, external trigeminal nerve stimulation, eTNS CARES
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)
Interventions
This intervention is expected to have an effect following a treatment period of 6 weeks.
DEVICESham Trigeminal Nerve Stimulation
This intervention is NOT expected to have an effect following a treatment period of 6 weeks.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ADHD Symptoms | Baseline to end of treatment at 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Responsiveness | Baseline to end of treatment at 6 weeks | Examine changes in social communication and related behaviors as measured by the Social Responsiveness Scale, Second Edition, Short Form (SRS-2-SF; range 0-48), where higher scores indicate worse impairment. |
| Change in Restricted and Repetitive Behaviors | Baseline to end of treatment at 6 weeks | Examine changes in restricted and repetitive behaviors as measured by the Repetitive Behavior Scale-Revised (RBS-R; range 0-129), where higher scores indicate more severe repetitive behaviors. |
| Change in Sleep Quality | Baseline to end of treatment at 6 weeks | Examine changes in sleep quality as measured by the Children's Sleep Habits Questionnaire (CSHQ; range 33-99), where higher scores indicate poorer sleep quality. |
Countries
United States
Outcome results
None listed