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NCT Number: NCT06277063

nVNS for the Prevention and Treatment of Primary Headache

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.

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Key information

Conditions

Primary Headache Brain Diseases Central Nervous System Diseases Cluster Headache Headache Disorders Headache Disorders, Primary Migraine in Adolescence Migraine in Children Nervous System Diseases Tension Headache Tension-Type Headache Trigeminal Autonomic Cephalalgias

Age range

7 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Ji Ya-Bin, post-doc

CONTACT

[email protected]

+8615913186246

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Age >=7 years old, <=20 years old;
  • Patients have experienced headache on 3-15 days per month in the past;
  • Maintain a stable dose and frequency of medication and do not take new drugs during the course of participating in the trial;
  • They volunteered to participate in the trial and signed informed consent.

Exclusion criteria

  • History of secondary headache, aneurysm, intracranial hemorrhage, brain tumor, severe head trauma, drug abuse, addiction, syncope, or seizures;
  • prior migraine-preventive surgery, cervical vagotomy, or implantation of an electronic or neurostimulator device;
  • Simultaneous use of other devices (e.g., TENS devices, muscle stimulators);
  • An implantable medical device in use, such as a pacemaker, hearing aid, or any implantable electronic device;
  • underwent head and neck nerve block within the past 2 months;
  • 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);
  • Patients who underwent cervical vagotomy (cervical vagotomy);
  • Pediatric patients (under 6 years old); Pregnant women;
  • Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia;
  • Patients with congenital heart disease;
  • Mental/cognitive disorders, etc.

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ji Ya-Bin, post-doc

CONTACT

[email protected]

+8615913186246

Xiao XueZhen, PhD

CONTACT

[email protected]

+8613425122570

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • BrainClos Company, LTD.
  • Zhuhai Fudan Innovation Institute

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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