Actively Recruiting
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms
Led by Beijing Tiantan Hospital · Updated on 2026-03-18
440
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in reducing postoperative headache among adults undergoing stent-assisted coiling for unruptured intracranial aneurysms (UIAs). The study will include male and female participants aged 18 to 80 years who are scheduled for endovascular treatment of UIAs with stent-assisted coiling or flow diverter devices. The main questions it aims to answer are: * Can taVNS reduce the incidence of headache within 90 days after stent-assisted embolization of UIAs? * Is taVNS safe and well-tolerated in this patient population? Researchers will compare patients receiving active taVNS to those receiving sham stimulation to determine if taVNS leads to fewer postoperative headaches and reduced need for analgesic medications. Participants will: * Wear a taVNS device on the left earlobe (active group) or cymba conchae (sham group) starting 1 day before the procedure * Receive 30-minute stimulation sessions, twice daily, until postoperative day 5 * Undergo follow-up assessments of headache occurrence, pain intensity, analgesic use, and any adverse events through day 90 after the procedure
CONDITIONS
Official Title
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years
- Diagnosed with unruptured intracranial aneurysm confirmed by imaging
- Planned to undergo stent-assisted coiling or flow diverter embolization
- Signed informed consent
You will not qualify if you...
- History of subarachnoid hemorrhage, intracerebral hemorrhage, brain tumor, major trauma, substance abuse, syncope, or seizures
- Recurrent, traumatic, infectious, or myxomatous aneurysms
- Primary headache disorders not caused by unruptured intracranial aneurysm
- Previous vagotomy, migraine surgery, or implanted neurostimulators
- Presence of other electronic or implantable devices like pacemakers
- Clinically significant hypotension, congenital heart disease, severe arrhythmia, unstable angina, or recent myocardial infarction
- Severe psychiatric disorder or refusal preventing follow-up
- Skin lesions at the site where taVNS device would be placed
- Pregnant or breastfeeding
- Participation in other clinical trials
AI-Screening
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Trial Site Locations
Total: 1 location
1
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Q
Qingyuan Liu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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