Noninvasive vagus nerve stimulation for prevention and treatment of primary headaches in children and teens
Noninvasive Vagus Nerve Stimulation for the Prevention and Treatment of Primary Headache: a Single-arm Single-center Clinical Trial.
We will try a noninvasive ear-based vagus nerve stimulator to treat sudden primary headache attacks in children and adolescents aged 7–20.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 7 Years to 20 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06277063 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children and adolescents 7–20 years old with diagnosed primary headaches (migraine, cluster, or tension-type) who experience 3–15 headache days per month and keep medications stable are ideal candidates.
Not a fit: Patients with secondary headaches, a history of seizures, implanted electronic devices, or those unable to attend in-person visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could offer a quick, non-drug option to reduce the intensity of acute headache attacks in children and adolescents.
How similar studies have performed: Similar nVNS approaches have shown promising but mixed results for acute migraine and cluster headache in adults, while pediatric evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.