A Safety and Feasibility Study of the Use of Cervical Spinal Cord Stimulation for Treatment of Cerebral Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Looking at number of patients without an adverse effect
研究概览
简要总结
The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm.
详细描述
The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm. Stimulation will be provided with electrodes placed percutaneously in the upper cervical epidural space. The outcome of 5 patients will be studied with focus on possible adverse events related to the intervention. Vasospasm response to treatment will be measured as a secondary outcome. Middle cerebral artery flow velocity will be followed by transcranial Doppler and clinical outcome measured by NIH stroke scale. Flow velocities will be monitored daily by transcranial Doppler and NIH stroke scale performed daily for 7 days, after which spinal cord stimulation will be discontinued and the epidural lead removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •a history of aneurysmal subarachnoid hemorrhage and will have aneurysm secured by clipping or coiling.
- •evidence of vasospasm on TCD with MCA mean flow velocity >120 cm/s.
- •Patients must be clinically stable to leave the ICU for the study intervention.
- •Patients will have Hunt and Hess grade 1-2 non-traumatic subarachnoid hemorrhage.
- •Patient should be oriented patients able to provide informed consent.
排除标准
- •Patients with non-aneurysmal hemorrhage
- •Patient with coagulopathy (PTT>40, or INR > 1.2)
- •thrombocytopenia (platelets <100 x 103 per mm2).
- •Use of anticoagulation or antiplatelet medication within the known clinical effective period of the particular medication.
- •allergy to nimodipine.
- •History of cervical or thoracic spine surgery.
- •Skin infection at site of catheter placement.
- •Sepsis. Pregnancy. Age less than 18 or greater than
- •Active diagnosis of cancer or history of metastatic cancer. Presence of cardiac defibrillator. Inability or unwillingness of patient to give informed consent. Patients found to be clinically neurologically unstable, hemodynamically unstable, or suffering from unstable intracranial pressure at the time of assessment for lead placement will not have the intervention.
研究组 & 干预措施
SCS in CV
干预措施: Spinal Cord Stimulation (Device)
结局指标
主要结局
Looking at number of patients without an adverse effect
时间窗: 7 days
次要结局
未报告次要终点