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

NCT ID: NCT05949528

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-12

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disorders of Consciousness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy controls (HCs)

Healthy controls (HCs)

no intervention

Intervention Type OTHER

no intervention

Emerged from Minimally Conscious State (EMCS)

Emerged from Minimally Conscious State (EMCS): recovery of functional object uses or communication from chronic

no intervention

Intervention Type OTHER

no intervention

Minimally conscious state (MCS)

Minimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness

no intervention

Intervention Type OTHER

no intervention

Vegetative state (VS)

Vegetative state (VS): can open their eyes and preserve sleep-wake cycles, but unaware of themselves and their surroundings

no intervention

Intervention Type OTHER

no intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benyuan Luo

Role: STUDY_CHAIR

Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yi Ling

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yi Ling

Role: CONTACT

15168236137

Fangping He

Role: CONTACT

13819114225

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yi Ling

Role: primary

15168236137

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EEG assessment

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brain Function and EEG
NCT05003076 COMPLETED EARLY_PHASE1
Touch and Attention MRI Study
NCT01432288 COMPLETED
Neural Bases of Motivation
NCT07251816 RECRUITING NA