External Trigeminal Nerve Stimulation Versus Sham Stimulation for Attention Deficit Hyperactivity Disorder in Children and Adolescents Aged 7-17 Years: Pilot and Feasibility Randomized Clinical Trial

What this Trial Is About

Researchers are evaluating the Monarch external trigeminal nerve stimulation (eTNS) device as a non-drug treatment for children and adolescents aged 7 to 17 years diagnosed with attention-deficit/hyperactivity disorder (ADHD). The study aims to assess the feasibility of using this device compared to a sham device and to pilot a larger clinical trial. The Monarch eTNS device offers a home-based, non-invasive option that requires family cooperation and compliance. Participants will be randomly assigned to use either the active Monarch eTNS device or a sham device for four weeks during nighttime. The active eTNS delivers short electrical pulses to stimulate the trigeminal nerve, with current levels adjusted for comfort. The sham device looks identical but provides minimal stimulation that mimics the sensation without therapeutic effect. During the trial, families will keep a logbook and complete questionnaires to track symptoms and device experience. Throughout the study, participants will be monitored for treatment compliance, safety, and adverse events. Researchers will assess core ADHD symptoms and autonomic functions using heart rate variability measurements. At the end of the trial, families will provide feedback on the device's acceptability and feasibility, informing whether a larger clinical trial is appropriate. The total participation lasts for four weeks with follow-up assessments during this period.

External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial