Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in inflammatory markers in the CSF
研究概览
简要总结
This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.
详细描述
Vagal nerve stimulation (VNS) has been studied in several inflammatory conditions, and has been implemented in animal models of subarachnoid hemorrhage (SAH) with promising results. The purpose of the proposed study is to determine how applying auricular VNS in patients presenting with spontaneous SAH impacts their expression of inflammatory markers in their blood and cerebrospinal fluid (CSF), and how it impacts their clinical course and outcomes.
This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood and CSF will be collected on admission, and serially throughout the patient's admission. Clinical events tracked during the hospital stay include development of cerebral vasospasm, need for CSF diversion via a shunt, stress-induced cardiomyopathy, and development of stroke or global cerebral ischemia. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores will be assessed and recorded by clinicians blinded to treatment arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneous subarachnoid hemorrhage
排除标准
- •Trauma-induced subarachnoid hemorrhage
- •Ongoing chemotherapy
- •Taking immunosuppressive medications for other medical illnesses
- •Presence of a pacemaker
- •Prolonged bradycardia at time of admission
结局指标
主要结局
Change in inflammatory markers in the CSF
时间窗: Through hospital admission, average of 4 weeks
TNF alpha from cerebrospinal fluid
Cerebral vasospasm
时间窗: Through hospital admission, average of 4 weeks
Presence of moderate/severe radiographic vasospasm
Hydrocephalus
时间窗: Through hospital admission, average of 4 weeks
Need for permanent CSF diversion via a ventricular shunt
Inflammatory markers in the serum on admission
时间窗: On hospital day 1
TNF alpha from blood draw
Change in inflammatory markers in the serum
时间窗: Through hospital admission, average of 4 weeks
TNF alpha from blood draws
Inflammatory markers in the CSF on admission
时间窗: On hospital day 1
TNF alpha from cerebrospinal fluid
次要结局
- Inflammatory markers in the serum on admission(On hospital day 1)
- Change in inflammatory markers in the serum(Through hospital admission, average of 4 weeks)
- Cerebral ischemia(Through hospital admission, average of 4 weeks)
- Hydrocephalus(Through hospital admission, average of 4 weeks)
- Stressed-induced cardiomyopathy(Through hospital admission, average of 4 weeks)
- Inflammatory markers in the CSF on admission(On hospital day 1)
- Cerebral vasospasm(Through hospital admission, average of 4 weeks)
- Change in inflammatory markers in the CSF(Through hospital admission, average of 4 weeks)
- Clinical outcome(2 years)
研究者
Anna Huguenard
Assistant Professor of Neurosurgery
Washington University School of Medicine