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临床试验/NCT05219331
NCT05219331招募中不适用

Impact of Hydrocephalus Treatment on Persistent Disorder of Consciousness Following Acute Brain Injury

University Hospital, Toulouse4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年9月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
4
主要终点
Coma Recovery Scale-revised scale

研究概览

简要总结

After acute brain injury or haemorrhagic stroke, hydrocephalus might participate to consciousness disorder. We plan to explore whether ventriculoperitoneal shunt insertion improves consciousness in patients with vegetative or minimally conscious state and hydrocephalus. Patients with acute brain injury, persistent consciousness disorder and hydrocephalus will be shunted with a detailed follow-up at 3 months combining: clinical evaluation, FluoroDésoxyGlucose positron emission tomography imaging, high density electroencephalogram, electrocardiogram Holter and sympathetic activity by microneurography.

详细描述

Persistent disorder of consciousness following acute brain injury is a major public health problem. Advances in intensive care allow a growing number of patients to survive after acute brain injury. However, one third of patients in coma following acute brain injury will not recover a consciousness. To date, no specific treatment has shown its effectiveness in the cognitive recovery of those patients. Few clinical cases suggest that hydrocephalus, which is the impairment of cerebrospinal fluid circulation in the brain, may participate to prolonged disorder of consciousness. Hence treating hydrocephalus with a shunt might improve disorders of consciousness. It is possible to gauge intracranial fluid circulation, that is hydrodynamics quantification, and measure resistance to cerebrospinal fluid outflow. Demonstration of an altered hydrodynamics favours the implantation of a shunt to improve cerebrospinal fluid circulation that might modulate brain region involved in the emergence of consciousness. The study hypothesis is that shunting a patient with persistent disorder of consciousness due to acute brain injury and hydrocephalus might improve his state of consciousness. The neural processes underlying will be assessed through comparative analyses of brain metabolic and electrophysiological signatures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt.

排除标准

  • pregnancy, no consent

研究组 & 干预措施

Disorder of consciousness

Other

Ventriculo peritoneal shunt

干预措施: Ventriculoperitoneal shunt (Procedure)

结局指标

主要结局

Coma Recovery Scale-revised scale

时间窗: 3 months and one years after shunt insertion

Yield stable estimates of patient consciousness status (higher scores mean better outcome)

次要结局

  • Holter electrocardiogram and blood pressure(3 months after shunt insertion)
  • catecholamines dosage(3 months after shunt insertion)
  • High density electroencephalogram(3 months after shunt insertion)
  • muscle sympathetic nerve activity(3 months after shunt insertion)
  • 18Ffluorodeoxyglucose positron emission tomography(3 months after shunt insertion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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