Brain Network Characteristics in Patients With Disorders of Consciousness

Sponsor

Xijing Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05558670

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disorders of Consciousness	Other: PET-fMRI-EEG

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
coma	Other: PET-fMRI-EEG Participants perform PET, fMRI, and EEG simultaneously using a MRI compatible EEG cap
VS/UWS	Other: PET-fMRI-EEG Participants perform PET, fMRI, and EEG simultaneously using a MRI compatible EEG cap
MCS	Other: PET-fMRI-EEG Participants perform PET, fMRI, and EEG simultaneously using a MRI compatible EEG cap
EMCS	Other: PET-fMRI-EEG Participants perform PET, fMRI, and EEG simultaneously using a MRI compatible EEG cap

Outcome Measures

Primary Outcome Measures

CRS-R total score [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).
GOSE score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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