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

RecruitingNAAges 18 Years - 80 YearsAllBeijing Tiantan Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Transcutaneous Auricular Vagus Nerve Stimulation
  • Sham transcutaneous auricular vagus nerve stimulation
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Where

1 site
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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