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NCT06277063
nVNS for the Prevention and Treatment of Primary Headache
NA trial testing Transcutaneous auricular vagus nerve stimulation in Primary Headache in 15 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Nanfang Hospital, Southern Medical University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 5 December 2024 |
| Primary completion | 31 August 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Transcutaneous auricular vagus nerve stimulation
Conditions studied
- Primary Headache — all drugs for Primary Headache →
- Migraine in Adolescence — all drugs for Migraine in Adolescence →
- Migraine in Children — all drugs for Migraine in Children →
- Cluster Headache — all drugs for Cluster Headache →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06277063
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Transcutaneous auricular vagus nerve stimulation
Trials testing the same drug.
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- NCT07163130 — Tragus Stimulation for POTS Treatment · NA · not yet recruiting
- NCT06642454 — A Randomized Double-Blind Active-Controlled Crossover Trial of Respiratory-Gated Versus Non-Gated Transcutaneous Auricul · NA · enrolling by invitation
Other Nanfang Hospital, Southern Medical University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06277063 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nanfang Hospital, Southern Medical University
- Last refreshed: 12 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06277063.
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