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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Xiao XueZhen, PhD
xuezhenxiao@brainclos.com
+8613425122570
Backup
Ji Ya-Bin, post-doc
yabinji@126.com
+8615913186246
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 15
Treatments
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.
Sponsors
Collaborators: BrainClos Company, LTD., Zhuhai Fudan Innovation Institute
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov