Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Detecting CSDs in TBI patients
研究概览
简要总结
Preliminary evaluation of depth electrode recording and novel algorithms to determine Cortical Spreading Depolarization's (CSD) following traumatic brain injury (TBI) requiring neurosurgical intervention.
详细描述
During the standard of care External Ventricular Drain (EVD) placement, a depth electrode with minimal modification to the standard surgical procedure will be placed. This will allow electrocorticogram (ECoG) recordings. An ECoG will be reviewed by a study Neurosurgeon to understand the association between cortical spreading depression and pathological findings on imaging. The recordings help create a novel algorithm in order to detect CSD's. This may ultimately provide significant benefit to society through the diagnosis and treatment of secondary injury associated with traumatic brain injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient recommended to undergo EVD placement for the monitoring and possible treatment of Intracranial pressure (ICP) after TBI
排除标准
- •Contaminated scalp lacerations
- •Known systemic infection
- •Non-English speaking
- •Fixed, uncorrectable coagulopathy
研究组 & 干预措施
Feasibility
This is a preliminary, prospective interventional study to investigate the feasibility of using depth electrodes in conjunction with novel analytical algorithms to detect CSDs in TBI patients.
干预措施: depth electrodes (Device)
结局指标
主要结局
Detecting CSDs in TBI patients
时间窗: 2 years
The primary endpoint is to determine the feasibility of using depth electrodes in conjunction with novel analytical algorithms to detect CSDs in TBI patients. A single depth electrode will be placed at the same time the EVD is performed. ECoG recordings from each patient will be recorded.
次要结局
未报告次要终点