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临床试验/NCT04411719
NCT04411719招募中不适用

Prognosis of Acute DOC

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: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Glasgow Outcome Scale-Extended (GOS-E)

研究概览

简要总结

Prior research has indicated a link between outcomes in patients with disorders of consciousness (DOC) and their responses to emotional auditory stimuli. Given the high degree of uncertainty in acute situations, this study plans to record EEG responses and observe microexpressions in DOC patients during exposure to auditory stimuli, with the aim to identify more reliable prognostic indicators. The goal is to uncover potential patterns or signals that can contribute to a more comprehensive understanding of a patient's condition, and thereby provide more accurate prognostication.

详细描述

This study intends to probe the potential of electroencephalography (EEG) and microexpression analysis for predicting the outcomes of acutely unresponsive patients within the intensive care unit (ICU). Previous research has illuminated a relationship between patients' emotional responses to auditory stimuli and their prognosis. However, the predictive utility of these responses in the context of acute conditions remains largely unexplored.

At the onset of the study, participants will undergo EEG monitoring while exposed to a pre-determined set of emotional auditory stimuli. Additionally, the patients' facial expressions will be captured via video for subsequent microexpression analysis.

Follow-up assessments of the patients' status will be conducted at three, six, and twelve-month intervals. Using cutting-edge analytical techniques, the goal is to decode these EEG and microexpression responses. This study aims to identify possible correlations between these findings, the patients' diagnoses, and their respective outcomes over time.

研究设计

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

入排标准

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

入选标准

  • Patients with acute brain injury (<28 days) in ICU
  • ≥ 2 days after sedation
  • Normal hearing, with auditory startle reflex

排除标准

  • Children under 18

结局指标

主要结局

Glasgow Outcome Scale-Extended (GOS-E)

时间窗: Month 12

GOSE will be assessed 12 months after brain injury.

次要结局

未报告次要终点

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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