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Clinical Evaluation of Chronic Consciousness Disorders Using Resting-state EEG and ERP

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05949528
Enrollment
200
Registered
2023-07-18
Start date
2021-12-12
Completion date
2024-06-30
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders of Consciousness

Keywords

resting-state electroencephalograms, ERP, microstate

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.

Interventions

OTHERno intervention

no intervention

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients diagnosed with COMA /VS/MCS 2. The course of disease was more than 4 weeks 3. The vital signs were stable and able to tolerate the test process 4. Complete skull 5. Right-handed, no history of ear disease or hearing loss before onset

Exclusion criteria

1. History of epilepsy 2. Sedatives 3. Muscle relaxants and epileptic prophylaxis within 24 hours

Design outcomes

Primary

MeasureTime frameDescription
Spectrum analysis of chronic disorders of consciousness6 monthsThe 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.
Duration of each microstate6 monthsThe 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.
Occurrence of each microstate6 monthsThe 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 microstate6 monthsThe 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

MeasureTime frameDescription
Coma Recovery Scale-Revised(CRS-R)30 minutes before samples collectionThe Coma Recovery Scale-Revised (CRS-R) score was utilized to measure the severity of the condition. It comprises 23 items arranged hierarchically into six subscales, including auditory, visual, motor, oromotor/verbal, communication, and arousal processes. Reflexive activity is represented by the lowest item on each subscale, while cognitively mediated behaviors are portrayed by the highest items. The scale ranges from 0 (indicating the lowest level of consciousness) to 23 (indicating the highest level of consciousness). Generally, a higher score suggests a better level of consciousness, while a lower score suggests a lower level of consciousness.
Glasgow Outcome Scale (GOS)6 monthsA GOS score ≥ 4 points is considered to indicate a good prognosis, while a GOS score \< 4 points is considered to indicate a poor prognosis

Countries

China

Contacts

Primary ContactYi Ling
lywenzhoumc@163.com15168236137
Backup ContactFangping He
lywenzhoumc@163.com13819114225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026