nVNS for the Prevention and Treatment of Primary Headache

Summary

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.

Conditions

• Primary Headache
• Migraine in Adolescence
• Migraine in Children
• Cluster Headache
• Tension Headache

Interventions

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.

Sponsors & Collaborators

• BrainClos Company, LTD.

  collaborator UNKNOWN

• Zhuhai Fudan Innovation Institute

  collaborator UNKNOWN

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Ji Ya-Bin, post-doc · Nanfang Hospital, Southern Medical University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

7 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-05

Primary Completion

2026-08-31

Completion

2026-12-30

Countries

• China

Study Locations