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

NCT05949528 | Unknown DMC

• 1 other identifier: EEG assessment
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorders of Consciousness

Keywords

resting-state electroencephalograms; ERP; microstate

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Coma Recovery Scale-Revised(CRS-R)

  30 minutes before samples collection

• Glasgow Outcome Scale (GOS)

  6 months

Study Arms (4)

Healthy controls (HCs)

Healthy controls (HCs)

Other: no intervention

Emerged from Minimally Conscious State (EMCS)

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

Other: no intervention

Minimally conscious state (MCS)

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

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

Other: no intervention

Interventions

no intervention OTHER

no intervention

Emerged from Minimally Conscious State (EMCS); Healthy controls (HCs); Minimally conscious state (MCS); Vegetative state (VS)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients diagnosed with COMA /VS/MCS
• The course of disease was more than 4 weeks
• The vital signs were stable and able to tolerate the test process
• Complete skull
• Right-handed, no history of ear disease or hearing loss before onset

You may not qualify if:

• History of epilepsy
• Sedatives
• Muscle relaxants and epileptic prophylaxis within 24 hours

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Yi Ling

Hangzhou, Zhejiang, 310000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Electroencephalogram (EEG) refers to the resting state and event-related potential (ERP) of the brain.

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Benyuan Luo

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

  STUDY CHAIR

Central Study Contacts

Yi Ling

CONTACT

15168236137; lywenzhoumc@163.com

Fangping He

CONTACT

13819114225; lywenzhoumc@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: July 18, 2023
• Study Start: December 12, 2021
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: July 18, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)