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Clinical Trials/NCT05558670
NCT05558670
Unknown
Not Applicable

Assessing Brain Network Characteristics in Patients With Disorders of Consciousness by Simultaneous Trimodal Positron Emission Tomography-Functional Magnetic Resonance Imaging-Electroencephalograph(PET-fMRI-EEG)Imaging

Xijing Hospital1 site in 1 country40 target enrollmentSeptember 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disorders of Consciousness
Sponsor
Xijing Hospital
Enrollment
40
Locations
1
Primary Endpoint
GOSE score
Last Updated
3 years ago

Overview

Brief Summary

Simultaneous measurement of the three modalities, functional magnetic resonance imaging (fMRI), positron emission tomography (PET) and electroencephalography (EEG) was proven to be feasible and advantageous in evaluating brain structural and functional (via fMRI), metabolic (via PET) and electrophysiological (via EEG) signatures simultaneously under the same conditions. Investigators use trimodal PET-fMRI-EEG imaging to explore the characteristics of brain network damage in patients with disorders of consciousness(DOC), assess the trajectory of consciousness recovery in a prospective observational cohort study.

Registry
clinicaltrials.gov
Start Date
September 2022
End Date
October 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Coma, VS/UWS, MCS and EMCS according to diagnostic criteria
  • Age ≥18 years
  • Written informed consent obtained

Exclusion Criteria

  • Patients with contraindications to PET, MRI, EEG examinations or inability to complete PET-fMRI-EEG examinations (presence of ferromagnetic metal implants or hyperthermia)
  • Hyperglycemia that is difficult to correct
  • Patients with long-term use of corticosteroids
  • Patients with coexisting severe systemic disease and limited life expectancy

Outcomes

Primary Outcomes

GOSE score

Time Frame: Patients are followed up for 6 months after enrolled

Glasgow Outcome Scale-Extended(GOSE) score is used to measure the functional limitations of participants. GOSE is a 1-8 point scale (1 = Death, 2 = Vegetative State, 3 = Lower Severe Disability, 4 = Upper Severe Disability, 5 = Lower Moderate Disability, 6 = Upper Moderate Disability, 7 = Lower Good Recovery, and 8 = Upper Good Recovery). Patients with higher scores are more independent.

CRS-R total score

Time Frame: Patients in coma after 3 weeks enrolled

The coma recovery scale-revised(CRS-R) total score is used to measure level of consciousness of disorder in enrolled patients. CRS-R consists of six subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.The lowest item on each subscale represents reflexive activity and the highest item represents cognitively mediated behavior. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).The score for each subscale is based on the presence or absence of a specific behavioral response to a sensory stimulus (higher scores are better).

Study Sites (1)

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