protocolSection identificationModule nctId: NCT06277063, orgStudyIdInfo id: NFEC-2024-057, briefTitle: nVNS for the Prevention and Treatment of Primary Headache, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, collaborators name: BrainClos Co., LTD., collaborators name: Zhuhai Fudan Innovation Institute, descriptionModule briefSummary: This study is a single-center, randomized, double-blind controlled study. Patients will be randomly assigned to two groups by envelope drawing. The subjects will be divided into two groups: the acute intervention group and the preventive intervention group. In each group, the subjects will be randomly divided into the experimental group and the control group by means of envelope extraction.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 attack and preventive 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., conditionsModule conditions: Primary Headache, conditions: Migraine in Adolescence, conditions: Migraine in Children, conditions: Cluster Headache, conditions: Tension Headache, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous auricular vagus nerve stimulation, interventions name: Sham transcutaneous auricular vagus nerve stimulation, outcomesModule primaryOutcomes measure: Visual analogue scales(VAS)-actue period, primaryOutcomes measure: Visual analogue scales(VAS)-prevention period, secondaryOutcomes measure: Heart rate variability(HRV), secondaryOutcomes measure: Electromyography(EMG), eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Ji Ya-Bin, post-doc, role: CONTACT, phone: +8615913186246, email: yabinji@126.com, geoPoint lat: 23.11667, lon: 113.25, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol, date: 2024-02-03, uploadDate: 2024-03-06T22:03, filename: Prot_SAP_ICF_002.pdf, size: 158671, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form: Informed Consent Form, date: 2024-02-03, uploadDate: 2024-03-06T22:01, filename: ICF_003.pdf, size: 139248, hasResults: False