Study of External Trigeminal Nerve Stimulation to Treat ADHD Symptoms in Children with Autism Spectrum Disorder Ages 7 to 14

What this Trial Is About

Researchers are studying if external trigeminal nerve stimulation eTNS can help reduce ADHD symptoms in children aged 7 to 14 who are on the autism spectrum ASD. The study also aims to learn how well the eTNS device is tolerated and whether it improves core and related features of ASD. The trial is sponsored by the University of California, San Francisco, and focuses on evaluating changes in ADHD symptoms, social responsiveness, repetitive behaviors, and sleep quality. Participants are randomly assigned to either use an active eTNS device or a sham placebo device for a treatment period of 6 weeks. The device is worn nightly with a small sticky patch placed on the childs forehead. Those who start with the sham device may have the opportunity to try the active device later. The study involves 4-5 in-person visits and 4 brief virtual check-ins over a total participation time of 8-12 weeks. During the study, children will undergo various assessments including questionnaires and testing to measure ADHD symptoms and ASD features. Both the child and their primary caregiver need to be fluent in English for the assessments. Researchers will monitor changes from baseline to the end of treatment at 6 weeks. Safety and tolerability of the device will also be observed throughout the trial period.

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