Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Primary efficacy outcome: Incidence of headache within postoperative day 5 to day 90
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Group
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.
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (Device)
Control Group
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.
干预措施: Sham transcutaneous auricular vagus nerve stimulation (Device)
结局指标
主要结局
Primary efficacy outcome: Incidence of headache within postoperative day 5 to day 90
时间窗: 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).
Primary safety outcome: Incidence of taVNS-related adverse events
时间窗: From 24 hr before surgery to 5 days after surgery
Incidence of taVNS-related adverse events: * Bradycardia (HR \< 50 bpm for ≥5 minutes) * Hypotension (MAP drop \> 20 mmHg or \>30% from baseline) * ECG abnormalities (ST changes or arrhythmias confirmed by cardiologist) * Symptomatic cerebral infarction (NIHSS score increase ≥2 with imaging evidence within 24h) * Local skin complications (redness, pain, injury ≥24h)
Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90
时间窗: Postoperative day 5-90
Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90
次要结局
- Headache incidence within postoperative day 5-30(Postoperative day 5 to day 30)
- VAS (Visual Analog Scale) scores on postoperative day 30 and 90(Postoperative day 30 and 90)
- 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)
- Postoperative day 90 levels of blood inflammatory cytokines(Postoperative day 90)
研究者
Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Beijing Tiantan Hospital