Noninvasive vagus nerve stimulation for prevention and treatment of primary headaches in children and teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, single-arm study enrolls participants aged 7–20 with primary headaches and applies transcutaneous auricular vagus nerve stimulation (nVNS) during acute exacerbations. Each subject receives the same short-duration stimulation with the electrode placed on the concha and stimulation intensity adjusted individually. Headache scores before and after the intervention will be compared to measure acute symptom change, and concurrent ECG and EMG data will be collected to develop objective response markers. Participants must have 3–15 headache days per month and maintain stable medication regimens during the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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).
2. Age \>=7 years old, \<=20 years old;
3. Patients have experienced headache on 3-15 days per month in the past;
4. Maintain a stable dose and frequency of medication and do not take new drugs during the course of participating in the trial;
5. They volunteered to participate in the trial and signed informed consent.

Exclusion Criteria:

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

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Ji Ya-Bin, post-doc — Nanfang Hospital, Southern Medical University
• Study coordinator: Xiao XueZhen, PhD
• Email: xuezhenxiao@brainclos.com
• Phone: +8613425122570

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.