Functional Connectivity Measurement After Severe Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- cortical functional connectivity
研究概览
简要总结
To compare functional connectivity after severe traumatic brain injury (TBI) between a group of post-comatose TBI with restored consciousness and a group of post-comatose TBI with persistant disorder of consciousness at admission in rehabilitation
详细描述
Recovery of consciousness can be impaired in severe traumatic brain injury (TBI). Prognostic factors are sparse and mostly clinical (mainly the initial Glasgow coma scale GCS) (1). Functional magnetic resonance imaging (fMRI) could allow a better understanding of functional recovery. Graph method has been applied to fMRI signal analysis in disorder of consciousness (DOC) due to post-anoxic encephalopathy. Comatose state was characterized by dramatic change in local connectivity (hub location) without significant change in global connectivity (2). The present study aims at describing functional connectivity in DOC following severe TBI. We will record resting state fMRI in TBI patients in two clinical conditions: conscious state versus DOC state.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •severe TBI
- •no general anesthesia since 7 days
- •no neuroleptic nor hypnotic drug since 3 days
- •medical criteria fulfilled to be discharged from ICU
- •medical insurance
排除标准
- •age < 18
- •contra indication to MRI
- •consent refusal from the family
- •neurological trouble before TBI
- •patient protected by law
结局指标
主要结局
cortical functional connectivity
时间窗: connectivity index measured on MRI recorded at discharge from intensive care unit (ICU) (30 days post-TBI on average) and compared between the two groups of patients (group "normal level of consciousness" versus group "disorder of consciousness")
the index is calculated from methodology of the article cited below (2)
次要结局
- consciousness level measured with Coma recovery scale -revised (CRS-R)(day 60 after first MRI)
- cortical functional connectivity change(connectivity index change (measured on MRI done day 60 after first MRI and compared to MRI done on day 0)
- Slow wave sleep quantification(EEG at discharge from intensive care unit (ICU) (30 days post-TBI on average))
- structural connectivity(DTI day 60 after first MRI)