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

Disorders of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949528
• Other study ID #: EEG assessment
• Status: Recruiting
• Start date: December 12, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2022
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Yi Ling
• Phone: 15168236137
• Email: lywenzhoumc[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Yi Ling	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spectrum analysis of chronic disorders of consciousness	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.	6 months
Primary	Duration of each microstate	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.	6 months
Primary	Occurrence of each microstate	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.	6 months
Primary	Global explained variance (GEV) of each microstate	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.	6 months
Secondary	Coma Recovery Scale-Revised(CRS-R)	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.	30 minutes before samples collection
Secondary	Glasgow Outcome Scale (GOS)	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	6 months