nVNS for the Prevention and Treatment of Primary Headache

August 6, 2025 updated by: Nanfang Hospital, Southern Medical University

Noninvasive Vagus Nerve Stimulation for the Prevention and Treatment of Primary Headache: a Single-arm Single-center Clinical Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ji Ya-Bin, post-doc
  • Phone Number: +8615913186246
  • Email: yabinji@126.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with migraine, cluster headache and tension-type headache were diagnosed according to Chinese Guidelines for the diagnosis and Treatment of Migraine (2022 edition) and Chinese Guidelines for the diagnosis and treatment of cluster headache (2022 edition).
  2. Age >=7 years old, <=20 years old;
  3. Patients have experienced headache on 3-15 days per month in the past;
  4. Maintain a stable dose and frequency of medication and do not take new drugs during the course of participating in the trial;
  5. They volunteered to participate in the trial and signed informed consent.

Exclusion Criteria:

  1. History of secondary headache, aneurysm, intracranial hemorrhage, brain tumor, severe head trauma, drug abuse, addiction, syncope, or seizures;
  2. prior migraine-preventive surgery, cervical vagotomy, or implantation of an electronic or neurostimulator device;
  3. Simultaneous use of other devices (e.g., TENS devices, muscle stimulators);
  4. An implantable medical device in use, such as a pacemaker, hearing aid, or any implantable electronic device;
  5. underwent head and neck nerve block within the past 2 months;
  6. Opioid use (more than 2 days per month); Use of analgesics alone or non-steroidal anti-inflammatory drugs (more than 15 days per month); Or tamoxifen, ergots or combination analgesics (more than 10 days per month);
  7. Patients who underwent cervical vagotomy (cervical vagotomy);
  8. Pediatric patients (under 6 years old); Pregnant women;
  9. Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia;
  10. Patients with congenital heart disease;
  11. Mental/cognitive disorders, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute exacerbation experimental group
VAS pain intensity will be assessed at the onset of headache, and patients will receive nVNS for half an hour within 20 minutes of the onset, and post-treatment evaluation results will be recorded immediately after treatment, 2 hours, 8-12 hours, 24 hours, and 36-48 hours. During the course of treatment and intervention, a 20-minute ECG closed-loop assessment test will be performed before admission and after return. The procedure included: 5 minutes of rest (i.e. no vagal stimulation), 10 minutes of vagal stimulation, 5 minutes of rest(5-10-5), a total of 20 minutes of ECG, and real-time extraction of heart rate and sex data. Neck electromyography before and after intervention was also used as an auxiliary indicator.
Device: Transcutaneous auricular vagus nerve stimulation
The vagus nerve's auricular branch is primarily distributed in the tragus, tragus sulcus, and concha cavity. It can activate the nucleus tractus solitarius through the vagus afferent fibers, thereby activating various areas of the vagus nerve in the central nervous system. This stimulation technique involves applying a constant current of around 2-3mA to the epidermal terminals of the ear using an electrode. It aims to regulate the vagus nerve, modulate the autonomic nervous system, release neurotransmitters, improve cerebral blood flow, and alleviate headache symptoms. In the implementation, non-invasive transcutaneous vagus nerve stimulation was performed by having the subject wear a vagus stimulator and adjusting the appropriate stimulation intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in pain intensity--actue period study
Time Frame: 2 hours after treatment

The visual analogue scale (VAS) was used to evaluate the pain. It is widely used in clinical practice in China. The basic method is to use a swimming ruler of about 10cm in length, marked with 10 scales on one side, and "0" and "10" scales on both ends.

For the AP study, the primary outcome measure is the reduction in pain intensity assessed by VAS 2 hours after treatment.
2 hours after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability(HRV)--actue period study and preventive period study
Time Frame: before and after the intervention. The test consisted of 5 mins of rest (i.e., no vagal stimulation), 10 mins of vagal stimulation, 5 mins of rest, and a total of 20 minutes of electrocard
A 20-minute closed-loop ECG assessment test was performed before and after the intervention for both the AP study and PP study. The test consisted of 5 minutes of rest (i.e., no vagal stimulation), 10 minutes of vagal stimulation, 5 minutes of rest, and a total of 20 minutes of electrocard.
before and after the intervention. The test consisted of 5 mins of rest (i.e., no vagal stimulation), 10 mins of vagal stimulation, 5 mins of rest, and a total of 20 minutes of electrocard
Electromyography(EMG)--actue period study and preventive period study
Time Frame: before and after the intervention. The test consisted of 5 mins of rest (i.e., no vagal stimulation), 10 mins of vagal stimulation, 5 mins of rest, and a total of 20 minutes of electrocard
A 20-minute closed-loop evaluation test of neck electromyography was performed before and after the intervention for both the AP study and PP study. The testing process consisted of 5 minutes of rest (i.e., no vagal stimulation), 10 minutes of vagal stimulation, 5 minutes of rest, and a total of 20 minutes of electrocard.
before and after the intervention. The test consisted of 5 mins of rest (i.e., no vagal stimulation), 10 mins of vagal stimulation, 5 mins of rest, and a total of 20 minutes of electrocard
Change in pain intensity--actue period study
Time Frame: half hour, 8-12 hours, 24 hours, and 36-48 hours after treatment
For the AP study, we will analysis the change in pain intensity assessed by VAS scores, half hour, 8-12 hours, 24 hours, and 36-48 hours after treatment.
half hour, 8-12 hours, 24 hours, and 36-48 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

Zhuhai Fudan Innovation Institute
BrainClos Company, LTD.

Investigators

  • Principal Investigator: Ji Ya-Bin, post-doc, Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 4, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2024-057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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