Noninvasive Vagus Nerve Stimulation for Prevention and Treatment of Primary Headache in Children and Adolescents: A Single-Arm Single-Center Clinical Trial

What this Trial Is About

Researchers are evaluating the use of noninvasive vagus nerve stimulation (nVNS) for treating primary headaches in children and adolescents aged 7 to 20 years. This single-center, single-arm study focuses on how nVNS affects headache pain during acute migraine attacks and aims to develop an objective system based on heart and muscle activity to measure headache improvement and optimize stimulation parameters. Participants will wear a vagus stimulator targeting the ear region rich in vagus nerve fibers. They will receive stimulation during an acute headache episode, with the intensity adjusted for each person. Pain levels will be recorded at multiple times: at headache onset, immediately after 30 minutes of stimulation within 20 minutes of headache start, and at 2 hours, 8-12 hours, 24 hours, and 36-48 hours post-treatment. Heart rate and neck muscle activity will be monitored before and after treatment using electrocardiogram (ECG) and electromyography (EMG). During the study, participants will have a 20-minute ECG test involving rest and stimulation phases to record heart rate and autonomic nervous system responses. Neck muscle EMG assessments will support the evaluation. The main outcome measured is the reduction in pain intensity two hours after treatment, with additional assessments of pain changes at other time points and physiological markers before and after intervention. The study will last through the treatment and monitoring periods as scheduled.

nVNS for the Prevention and Treatment of Primary Headache