Brain Network Characteristics in Patients With Disorders of Consciousness

• Conditions: Disorders of Consciousness

• Registration Number: NCT05558670
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-25
• Last Update Submitted: 2022-09-25
• Study First Posted: 2022-09-28
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-04
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China