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

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.

Study Overview

• Status: Recruiting
• Conditions: Disorders of Consciousness
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yi Ling; Phone Number: 15168236137; Email: lywenzhoumc@163.com
• Study Contact Backup: Name: Fangping He; Phone Number: 13819114225; Email: lywenzhoumc@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Yi Ling
      • Contact: Yi Ling; Phone Number: 15168236137; Email: lywenzhoumc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic disorder of consciousness were enrolled in the Hangzhou Mingzhou Brain Rehabilitation Hospital, and healthy controls were all recorded by the First Affiliated Hospital of Zhejiang University.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Study Chair: Benyuan Luo, Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2021
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: ERP; resting-state electroencephalograms; microstate
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: EEG assessment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No