Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Auricular Vagus Nerve Stimulation, Sham transcutaneous auricular vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Unruptured Intracranial Aneurysm, Headache, Vagus Nerve Stimulations. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Interventions
- Device Transcutaneous Auricular Vagus Nerve Stimulation
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 - Device Sham transcutaneous auricular vagus nerve stimulation
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.
Primary outcome measures
- Primary efficacy outcome: Incidence of headache within postoperative day 5 to day 90 [Time frame: Postoperative day 5 to day 90]
- Primary safety outcome: Incidence of taVNS-related adverse events [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 outcome measures (5)
- Headache incidence within postoperative day 5-30 [Time frame: Postoperative day 5 to day 30]
- VAS (Visual Analog Scale) scores on postoperative day 30 and 90 [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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- History of SAH, ICH, brain tumor, major trauma, substance abuse, syncope, or seizures
- Recurrent/traumatic/infectious/myxomatous aneurysms
- Primary headache disorders (e.g., migraine, cluster headache, trigeminal neuralgia) not attributed to UIA
- Previous vagotomy, migraine surgery, or implanted neurostimulators
- Other concurrent electronic/implantable devices (e.g., pacemakers, neurostimulators)
- Clinically significant hypotension, congenital heart disease, severe arrhythmia, unstable angina, or recent MI
- Inability to follow up due to severe psychiatric disorder or refusal
- Skin lesions at taVNS placement site
- Pregnant or lactating
- Participation in other trials
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Capital Medical University Affiliated Beijing Tiantan Hospital — Beijing
Identifiers
NCT: NCT07479082 · KY2025-284