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临床试验/NCT03502837
NCT03502837已完成不适用

Effects of Emotional Stimuli in Patients With Disorders of Consciousness: An Electroencephalography and Neuroimaging Study

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年2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
60
试验地点
1
主要终点
electrophysiological index:the cognitive event-related potentional components

研究概览

简要总结

Disentangling the vegetative state from the minimally conscious state is often difficult when relying only on behavioral observation. In this study, the investigators explored a new event-related potential paradigm as an alternative method for the detection of voluntary brain activity and cognitive abilities in the patients with disorders of consciousness.

详细描述

Auditory emotional stimuli have potential beneficial effects on cognitive functions and consciousness in patients with disorders of consciousness (DOC); however, precise and accurate quantitative indices to estimate cerebral activation to different auditory stimuli remain scarce. In this study, investigators assessed the response of different brain regions to emotional stimuli using ERP(Event-related potential),and further investigated the brain activation network.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
  • Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
  • Lack of autonomic crisis since one week minimum
  • Medical condition considered stable
  • Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.

排除标准

  • hearing Problem
  • Uncontrolled Epilepsy
  • Autonomic crises
  • Medical unstable state
  • Pregnant or likely to be (interrogation data) or breastfeeding woman
  • Healthy controls:
  • Inclusion Criteria:
  • Subjects with normal hearing
  • Absence of neurological disorder
  • Subjects able to understand the experimental instructions
  • Exclusion Criteria:
  • Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz
  • Neurological disorders
  • Pregnant or likely to be (interrogation data) or breastfeeding woman

结局指标

主要结局

electrophysiological index:the cognitive event-related potentional components

时间窗: from 200 msec before the stimuli onset to 1000ms after the auditory stimulation

The event-related potential waveforms uncover voluntary responses to external stimuli that could assist in detecting signs of consciousness to reduce the risk of misdiagnosis. P300 is a large positive going potential that increases in amplitude from the frontal to parietal electrodes and has a peak latency of about 300 ms for auditory and 400 ms for visual stimuli. And N1 is a negative potential in the posterior superior temporal lobe with the peak latency of about 170ms.Peak amplitudes and latency were obtained for the interest ERP components(N1,P300) .Peak amplitudes and latency for were analysed in a series of repeated-measures ANOVAs for each component (N1, P2), with factors of condition (emotion: mean happy/angry vs. neutral).

次要结局

  • CRS-R(Coma Recovery Scale-Revised)(30 minutes before the auditory stimualtion and 30 minutes after each stimulation)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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