Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Prevention of cerebral vasospasm
研究概览
简要总结
The study investigates safety, feasibility and effectiveness of cervical spinal cord stimulation (SCS) in prevention of cerebral arterial vasospasm following aneurysmal subarachnoid hemorrhage (aSAH).
It is postulated that 2 week long stimulation of the cervical spinal cord using an implanted epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following aSAH.
详细描述
Continuous stimulation of the cervical spinal cord for 14 days after electrode implantation (within 3 days after aneurysmal subarachnoid hemorrhage). The single-arm single-institution non-randomized prospective study evaluates effects of cervical spinal cord stimulation on prevention of cerebral arterial vasospasm.
The patients are followed for 12 months after completion of stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Subarachnoid hemorrhage (SAH) within 72 hours
- •Ruptured aneurysm confirmed by angiography of CT angiography
- •Fisher grade 2-4
- •Hunt & Hess grade 2-4
- •Aneurysm is secured
- •Ability to obtain informed consent
排除标准
- •Pregnancy
- •Allergy to IV contrast or to any component of SCS system
- •Non-aneurysmal SAH
- •Previous cervical spine surgery or any anomaly of cervical spine that would prevent electrode insertion
- •Coagulopathy
结局指标
主要结局
Prevention of cerebral vasospasm
时间窗: 14-17 days after aSAH
次要结局
- Any complication of spinal cord stimulation(up to 12 months)
研究者
Konstantin V. Slavin
Professor
University of Illinois at Chicago