NCT07479082 Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms
| NCT ID | NCT07479082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Unruptured Intracranial Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2025-09-30 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07479082 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Unruptured Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07479082 currently recruiting?
Yes, NCT07479082 is actively recruiting participants. Contact the research team at 13260457220@163.com for enrollment information.
Where is the NCT07479082 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07479082 clinical trial?
NCT07479082 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 440 participants.