跳至主要内容
临床试验/NCT01467908
NCT01467908已完成不适用

Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

Clinical Institute of the Brain, Russia2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
2
主要终点
MEP(motor evoked potential) parameter: latency

研究概览

简要总结

It has already been demonstrated that mental imagining of the complex motor act, such as limb lifting, can evoke the activation of the involved motor centres even if it doesn't result in movement due to paresis. Aim of the study: using the navigated brain stimulation system create a new diagnostic model for the differential diagnostics between the vegetative state and the minimally conscious state. If the investigators could get from patient the efferent motor response after a verbal command, his level of conscious should not be defined less than the minimally conscious state.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed vegetative state
  • age 20-85

排除标准

  • oncological history
  • cardiac pacemakers and other metal implants
  • Modified Ashford Scale scores 3 and more
  • predisposing disease with motor neurologic impairment

结局指标

主要结局

MEP(motor evoked potential) parameter: latency

时间窗: within the first minute after a verbal command

次要结局

  • MEP(motor evoked potential) parameter: amplitude(within the first minute after a verbal command)
  • MEP(motor evoked potential) parameter: motor threshold(within the first minute after a verbal command)
  • conscious state(within the first 6 months after NBS mapping)

研究者

发起方
Clinical Institute of the Brain, Russia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana Vikulova

MD, neurologist, investigator

Clinical Institute of the Brain, Russia

研究点 (2)

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