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

July 14, 2023 updated by: First Affiliated Hospital of Zhejiang University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coma Recovery Scale-Revised(CRS-R)
Time Frame: 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.
30 minutes before samples collection
Glasgow Outcome Scale (GOS)
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Benyuan Luo, Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings