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临床试验/NCT05949528
NCT05949528招募中不适用

Assessing Chronic Consciousness Disorders in Patients Using Clinical Evaluation With Resting-state EEG and ERPs: an Extensive Study Exploring Efficacy and Diagnostic Potential of EEG and ERP Measurements

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年12月12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
200
试验地点
1
主要终点
Duration of each microstate

研究概览

简要总结

Currently, there are significant challenges in the clinical assessment of patients with consciousness disorders, such as distinguishing between vegetative state (VS) and minimally conscious state (MCS), and predicting patient prognosis. This study aims to utilize different research techniques, such as auditory stimulation, as well as modified microstate methods, to enhance the disease classification and prognosis prediction of patients with chronic consciousness disorders.

详细描述

The investigators collected resting-state electroencephalograms (EEGs) and EEGs under various event-related potential (ERP) stimuli from patients with chronic consciousness disorders, and performed analyses on these data. The resting-state EEGs were subjected to spectral analysis and microstate analysis. The ERP EEGs were analyzed in the time domain, as well as for phase coupling and other measures.Using these computed indicators, the investigators use machine learning, deep learning, and other methods to predict disease classification and prognosis assessment in patients with chronic consciousness disorders.

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
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with COMA /VS/MCS
  • The course of disease was more than 4 weeks
  • The vital signs were stable and able to tolerate the test process
  • Complete skull
  • Right-handed, no history of ear disease or hearing loss before onset

排除标准

  • History of epilepsy
  • Muscle relaxants and epileptic prophylaxis within 24 hours

结局指标

主要结局

Duration of each microstate

时间窗: 6 months

The investigators conducted resting state EEG recordings on 59 patients with consciousness disorders and 32 healthy controls. The investigators refined the microstate method to accurately estimate topographical differences. The calculations were performed for measures of duration (ms). The duration of each microstate were utilized to predict disease classification and prognosis evaluation for patients with disturbance of consciousness.

Spectrum analysis of chronic disorders of consciousness

时间窗: 6 months

The EEG of 59 patients with disturbance of consciousness will be collected in resting state and listening to music, and the absolute power spectral density values (alpha,beta,theta,delta bands dB/Hz) will be calculated using spectral analysis.

Occurrence of each microstate

时间窗: 6 months

The investigators conducted resting state EEG recordings on 59 patients with consciousness disorders and 32 healthy controls. The investigators refined the microstate analysis. The calculations were performed for measures of occurrence (times per minute). The occurrence of microstates were utilized to predict disease classification and prognosis evaluation for patients with disturbance of consciousness.

Global explained variance (GEV) of each microstate

时间窗: 6 months

The investigators conducted resting state EEG recordings on 59 patients with consciousness disorders and 32 healthy controls. The investigators refined the microstate analysis. The calculations were performed for measures of GEV (%). The GEV of microstates were utilized to predict disease classification and prognosis evaluation for patients with disturbance of consciousness.

次要结局

  • Glasgow Outcome Scale (GOS)(6 months)
  • Coma Recovery Scale-Revised(CRS-R)(30 minutes before samples collection)

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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