External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-14
SponsorUniversity of California, San Francisco
About this trial
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)
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Trigeminal Nerve Stimulation
- Sham Trigeminal Nerve Stimulation
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov