Condition: Primary Headache · Migraine in Adolescence · Migraine in Children · Sponsor: Nanfang Hospital, Southern Medical University
This study is a single-center, single-arm study. All subjects will receive the same treatment. Children and adolescents (7-20 years old) with migraine who met the inclusion criteria will be enrolled as subjects in the experimental group, and the changes in headache scores before and after the intervention will be compared. The intervention method is as follows: ictal intervention, in which subjects will be evaluated for headache improvement after a short intervention during an acute exacerbation. By wearing a vagus stimulator, the stimulating electrode will be located in the concha region rich in vagus nerve fiber endings, and the appropriate stimulation intensity will be adjusted for stimulation. Therefore, this study will verify the effect of nVNS on the acute treatment of primary headache in children and adolescents. Based on the electrocardiogram and electromyography indicators during the intervention process of nVNS, an objective evaluation system for the improvement of headache by nVNS is established, and the role of stimulation parameters on the effect is further explored to realize the optimization of parameters.
This description comes directly from the study's public registry record.
Xiao XueZhen, PhD · +8613425122570 · xuezhenxiao@brainclos.com
Ji Ya-Bin, post-doc · +8615913186246 · yabinji@126.com
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| Nanfang Hospital, Southern Medical University | Guangzhou, Guangdong, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06277063