Brain Network Characteristics in Patients With Disorders of Consciousness

Disorders of Consciousness Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558670
• Other study ID #: 20222068
• Status: Recruiting
• Start date: September 2022
• Est. completion date: October 2023

Study information

• Verified date: August 2022
• Source: Xijing Hospital
• Contact: Rong Chen
• Phone: 18292575563
• Email: cmuchenrong[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

Intervention

Other:
• PET-fMRI-EEG
Participants perform PET, fMRI, and EEG simultaneously using a MRI compatible EEG cap

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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