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

Zhejiang University logo

Zhejiang University

Status

Enrolling

Conditions

Disorders of Consciousness

Treatments

Other: no intervention

Study type

Observational

Funder types

Other

Identifiers

NCT05949528
EEG assessment

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

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

Trial contacts and locations

1

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Central trial contact

Yi Ling; Fangping He

Data sourced from clinicaltrials.gov

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