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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating transcutaneous auricular vagus nerve stimulation (taVNS) to see if it can reduce postoperative headaches in adults aged 18 to 80 years undergoing stent-assisted coiling or flow diverter embolization for unruptured intracranial aneurysms (UIAs). The study aims to determine if taVNS decreases the occurrence of headaches within 90 days after treatment and assesses its safety and tolerability in this group. Participants will be randomly assigned to receive either active taVNS or sham stimulation. The active group will use a taVNS device applied to the left cymba conchae starting 24 hours before surgery until 5 days after, with 30-minute stimulation sessions twice daily. The sham group will have the device placed on the left earlobe without electrical current but with the same schedule and parameters. Stimulation parameters include a pulse width of 200-300 microseconds at 25 Hz, alternating 30 seconds on and 30 seconds off. During the study, participants will be monitored for headache incidence, pain levels using a visual analog scale, analgesic use, and any side effects through 90 days after the procedure. Researchers will also measure blood inflammatory cytokines on postoperative days 5 and 90. Safety assessments will focus on adverse events related to taVNS from 24 hours before surgery to 5 days after. Follow-up visits and evaluations will track both efficacy and safety outcomes throughout the study period.
CONDITIONS
Brief 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 to 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 related to unruptured intracranial aneurysm (e.g., migraine, cluster headache, trigeminal neuralgia)
- Previous vagotomy, migraine surgery, or implanted neurostimulators
- Presence of other implantable electronic devices such as pacemakers or neurostimulators
- Clinically significant hypotension, congenital heart disease, severe arrhythmia, unstable angina, or recent myocardial infarction
- Severe psychiatric disorder or refusal to follow up
- Skin lesions at the site of taVNS device placement
- Pregnant or lactating women
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive transcutaneous auricular vagus nerve stimulation or sham stimulation starting 24 hours before surgery.
1 visit before surgery
Duration - Day of surgery
Participants undergo stent-assisted coiling or flow diverter embolization surgery.
1 visit (in-person)
Duration - 6 days (from 24 hours before surgery to 5 days after surgery)
Participants receive transcutaneous auricular vagus nerve stimulation or sham stimulation twice daily from surgery through 5 days after surgery.
Twice daily device use sessions
Duration - Postoperative day 5 to day 90
Participants are monitored for headache incidence and safety outcomes through postoperative day 90.
Visits on postoperative days 5, 30, and 90
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.
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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