Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms

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

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