Gentle ear vagus nerve stimulation to reduce headache after aneurysm stent coiling

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

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.