Gentle ear vagus nerve stimulation to reduce headache after aneurysm stent coiling
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms
This study will try a noninvasive ear vagus nerve stimulation device to see if it reduces postoperative headaches in adults having stent-assisted coiling or flow-diverter treatment for unruptured brain aneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07479082 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–80 scheduled for stent-assisted coiling or flow-diverter embolization for unruptured intracranial aneurysms are randomized to receive active transcutaneous auricular vagus nerve stimulation (taVNS) or a sham placement. Participants begin wearing the device one day before the procedure and continue per protocol, with the active device placed on the left earlobe and the sham on the cymba conchae. The study compares incidence of headache within 90 days and use of analgesic medications between groups and monitors safety and tolerability. The trial is conducted at Capital Medical University Affiliated Beijing Tiantan Hospital as a single-center interventional study.
Who should consider this trial
Good fit: Adults 18–80 with imaging-confirmed unruptured intracranial aneurysms who are scheduled for stent-assisted coiling or flow-diverter embolization and can give informed consent are ideal candidates.
Not a fit: Patients with primary chronic headache disorders, prior seizures or vagotomy, implanted electronic devices, significant cardiac instability, skin lesions at the ear site, pregnancy, or other listed exclusions are not eligible and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, taVNS could lower the frequency and severity of headache after aneurysm stent procedures and reduce the need for pain medications.
How similar studies have performed: Small pilot trials of taVNS have shown promise for some headache and pain conditions, but using taVNS specifically to prevent postoperative headache after aneurysm coiling is a relatively novel application with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-80 years 2. Diagnosed with unruptured intracranial aneurysm confirmed by imaging 3. Planned to undergo stent-assisted coiling or flow diverter embolization 4. Signed informed consent Exclusion Criteria: 1. History of SAH, ICH, brain tumor, major trauma, substance abuse, syncope, or seizures 2. Recurrent/traumatic/infectious/myxomatous aneurysms 3. Primary headache disorders (e.g., migraine, cluster headache, trigeminal neuralgia) not attributed to UIA 4. Previous vagotomy, migraine surgery, or implanted neurostimulators 5. Other concurrent electronic/implantable devices (e.g., pacemakers, neurostimulators) 6. Clinically significant hypotension, congenital heart disease, severe arrhythmia, unstable angina, or recent MI 7. Inability to follow up due to severe psychiatric disorder or refusal 8. Skin lesions at taVNS placement site 9. Pregnant or lactating 10. Participation in other trials
Where this trial is running
Beijing, Beijing Municipality
- Capital Medical University Affiliated Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qingyuan Liu, M.D.
- Email: 13260457220@163.com
- Phone: +86-13260457220
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.