Brain Network Characteristics in Patients With Disorders of Consciousness

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

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.

Study Overview

• Status: Recruiting
• Conditions: Disorders of Consciousness
• Intervention / Treatment: Other: PET-fMRI-EEG

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants are selected in patients hospitalised in neurology department of Xijing hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRS-R total score	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).	Patients in coma after 3 weeks enrolled
GOSE score	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.	Patients are followed up for 6 months after enrolled

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Director: Wen Jiang, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 25, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: coma; brain network; PET-fMRI-EEG; Vegetative state(VS); Unresponsive wakefulness syndrome (UWS); Minimally conscious state(MCS); Emerged from minimally conscious state(EMCS)
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: 20222068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No