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

Beijing Tiantan Hospital440 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

440

Conditions

Unruptured Intracranial Aneurysm Headache

Interventions

Transcutaneous Auricular Vagus Nerve StimulationDEVICE

Participants will receive transcutaneous auricular vagus nerve stimulation via a taVNS device applied to the left cymba conchae starting 24 hours before surgery to 5 days after surgery. Stimulation will be administered twice daily, with a 12-hour interval between sessions. Parameters: pulse width of 200-300 µs at 25 Hz and a biphasic pulse interval of 30 s ON and 30 s OFF. The stimulus intensity of the tVNS varied between individuals and is set to the average level, which is defined by the level above the detection threshold but below the pain perception threshold.

Sham transcutaneous auricular vagus nerve stimulationDEVICE

Participants will receive transcutaneous auricular vagus nerve stimulation but without electrical current via a taVNS device applied to the left earlobe starting 24 hours before surgery twice daily until postoperative day 5. Stimulation parameters, frequency and duration are identical to the experimental group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary efficacy outcome: Incidence of headache within postoperative day 5 to day 90

Incidence of headache within postoperative day 5 to day 90, defined as headache lasting ≥4 hours or requiring acute analgesic treatment, excluding secondary causes (e.g., hemorrhage, trauma).

Time frame: Postoperative day 5 to day 90

Primary safety outcome: Incidence of taVNS-related adverse events

Incidence of taVNS-related adverse events: * Bradycardia (HR \< 50 bpm for ≥5 minutes) * Hypotension (MAP drop \> 20 mmHg or \>30% from baseline) * ECG abnormalities (ST changes or arrhythmias confirmed by cardiologist) * Symptomatic cerebral infarction (NIHSS score increase ≥2 with imaging evidence within 24h) * Local skin complications (redness, pain, injury ≥24h)

Time frame: From 24 hr before surgery to 5 days after surgery

Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90

Time frame: Postoperative day 5-90

Secondary Outcomes

Headache incidence within postoperative day 5-30

Incidence of headache within postoperative day 5 to day 30, defined as headache lasting ≥4 hours or requiring acute analgesic treatment, excluding secondary causes (e.g., hemorrhage, trauma).

Time frame: Postoperative day 5 to day 30

VAS (Visual Analog Scale) scores on postoperative day 30 and 90

VAS (Visual Analog Scale) scores on postoperative day 30 and 90. Visual Analog Scale (range: 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain outcomes.

Time frame: Postoperative day 30 and 90

Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-30

Time frame: Postoperative day 5-30

Postoperative day 5 levels of blood inflammatory cytokines

Time frame: Postoperative day 5

Postoperative day 90 levels of blood inflammatory cytokines

Time frame: Postoperative day 90