NCT06277063Recruiting
nVNS for the Prevention and Treatment of Primary Headache
Noninvasive Vagus Nerve Stimulation for the Prevention and Treatment of Primary Headache: a Single-arm Single-center Clinical Trial.
Source: ClinicalTrials.gov · Last updated 12 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 4 Feb 2024
- Start date
- 5 Dec 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Migraine
- NCT number
- NCT06277063
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 5 Dec 2024 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior migraine-preventive surgery, cervical vagotomy, or implantation of an electronic or neurostimulator device;
- 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);
Other illness
- History of secondary headache, aneurysm, intracranial hemorrhage, brain tumor, severe head trauma, drug abuse, addiction, syncope, or seizures;
- Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia;
- Patients with congenital heart disease;
- Mental/cognitive disorders, etc.
Age
- Pediatric patients (under 6 years old); Pregnant women;
Other
- 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;
- Patients who underwent cervical vagotomy (cervical vagotomy);
Who the study is looking for
- 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.
Age in the registry: 7 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.