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Clinical Trials/NCT05949528
NCT05949528
Recruiting
Not Applicable

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 site in 1 country200 target enrollmentDecember 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disorders of Consciousness
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
200
Locations
1
Primary Endpoint
Duration of each microstate
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2021
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Duration of each microstate

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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