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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
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| Control Group | Sham Comparator | Sham stimulation with the device placed at the left cymba conchae without electrical current. Stimulation parameters, frequency and duration are identical to the experimental group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Postoperative day 5 to day 90 |
| Primary safety outcome: Incidence of taVNS-related adverse events | Incidence of taVNS-related adverse events:
| 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 | Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90 | Postoperative day 5-90 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Postoperative day 5 to day 30 |
| VAS (Visual Analog Scale) scores on postoperative day 30 and 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingyuan Liu, M.D. | Contact | +86-13260457220 | 13260457220@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Affiliated Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Sham transcutaneous auricular vagus nerve stimulation | Device | 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. |
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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. |
| Postoperative day 30 and 90 |
| Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-30 | Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-30 | Postoperative day 5-30 |
| Postoperative day 5 levels of blood inflammatory cytokines | Postoperative day 5 levels of blood inflammatory cytokines | Postoperative day 5 |
| Postoperative day 90 levels of blood inflammatory cytokines | Postoperative day 90 levels of blood inflammatory cytokines | Postoperative day 90 |
| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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