Actively Recruiting
nVNS for the Prevention and Treatment of Primary Headache
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-08-12
15
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
N
Nanfang Hospital, Southern Medical University
Lead Sponsor
B
BrainClos Company, LTD.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
nVNS for the Prevention and Treatment of Primary Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with migraine, cluster headache, or tension-type headache according to Chinese guidelines
- Aged between 7 and 20 years old
- Experienced headaches on 3 to 15 days per month in the past
- Taking stable doses and frequency of medications without new drugs during the study
- Volunteered and signed informed consent
You will not qualify if you...
- History of secondary headache, aneurysm, brain hemorrhage, tumor, severe head trauma, drug abuse, addiction, syncope, or seizures
- Previous migraine-preventive surgery, cervical vagotomy, or electronic/neurostimulator implantation
- Use of other devices like TENS or muscle stimulators
- Presence of implantable medical devices such as pacemaker or hearing aid
- Had head and neck nerve block within past 2 months
- Opioid use more than 2 days per month or frequent use of analgesics/non-steroidal anti-inflammatory drugs
- Underwent cervical vagotomy
- Younger than 7 years old or pregnant women
- Clinically significant hypertension, hypotension, bradycardia, or tachycardia
- Congenital heart disease
- Mental or cognitive disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
X
Xiao XueZhen, PhD
CONTACT
J
Ji Ya-Bin, post-doc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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