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

Recruiting

• Conditions: Disorders of Consciousness
• Interventions: Other: no intervention

• Registration Number: NCT05949528
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Study Timeline

• Study Start: 2021-12-12
• Study First Submitted: 2022-03-14
• Status Verified: 2022-10
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls (HCs)	no intervention	Healthy controls (HCs)
Vegetative state (VS)	no intervention	Vegetative state (VS): can open their eyes and preserve sleep-wake cycles, but unaware of themselves and their surroundings
Emerged from Minimally Conscious State (EMCS)	no intervention	Emerged from Minimally Conscious State (EMCS): recovery of functional object uses or communication from chronic
Minimally conscious state (MCS)	no intervention	Minimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness

Primary Outcome Measures

Name	Time	Method
Duration of each microstate	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	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	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	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 Outcome Measures

Name	Time	Method
Glasgow Outcome Scale (GOS)	6 months	A GOS score ≥ 4 points is considered to indicate a good prognosis, while a GOS score \< 4 points is considered to indicate a poor prognosis
Coma Recovery Scale-Revised(CRS-R)	30 minutes before samples collection	The 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.

Trial Locations

Locations (1)

Yi Ling; 🇨🇳 Hangzhou, Zhejiang, China