RecruitingNot ApplicableNCT07479082

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

Sponsor

Beijing Tiantan Hospital

Enrollment

440 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Unruptured Intracranial Aneurysm Headache Vagus Nerve Stimulations

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether transcutaneous auricular vagus nerve stimulation (taVNS) — a non-invasive ear-worn device that gently stimulates the vagus nerve — can reduce headaches after endovascular surgery for unruptured brain aneurysms (saccular bulges in brain blood vessels that are treated before they rupture). Postoperative headache is a common and bothersome complication of this type of procedure. Adults aged 18 to 80 with a confirmed unruptured intracranial aneurysm scheduled for stent-assisted coiling or flow diversion may be eligible, while those with prior headache disorders like migraine, implanted devices such as pacemakers, or recent heart attacks are excluded. Participation involves wearing a taVNS or sham (inactive) device on the ear starting the day before surgery and for 5 days after, with follow-up assessments of headache occurrence and pain through 90 days post-procedure. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous 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 above the detection threshold but below the pain perception threshold.

DEVICESham 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.