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NCT06277063

nVNS for the Prevention and Treatment of Primary Headache

Recruiting now NA Last updated 12 August 2025
What this trial tests

NA trial testing Transcutaneous auricular vagus nerve stimulation in Primary Headache in 15 participants. Currently enrolling.

Timeline
5 December 2024
Primary endpoint
31 August 2026
30 December 2026

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date5 December 2024
Primary completion31 August 2026
Estimated completion30 December 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 7 to 20, any sex, with Primary Headache or Migraine in Adolescence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Single-centre, randomised and double-blind clinical trial on the efficacy of transcutaneous auricular vagus nerve stimulation in preventing and treating primary headache in children and adolescents: a study protocol.
    Weng S, Xiao X, Liang S, Xue Y, et al · · 2025 · cited 1× · PMID 40074270 · DOI 10.1136/bmjopen-2024-092692

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Other trials of Transcutaneous auricular vagus nerve stimulation

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