NCT05558670

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

September 28, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

September 1, 2022

Last Update Submit

September 25, 2022

Conditions

Disorders of Consciousness

Keywords

PET-fMRI-EEGbrain networkcomaVegetative state(VS)Unresponsive wakefulness syndrome (UWS)Minimally conscious state(MCS)Emerged from minimally conscious state(EMCS)

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

coma

Other: PET-fMRI-EEG

VS/UWS

Other: PET-fMRI-EEG

MCS

Other: PET-fMRI-EEG

EMCS

Other: PET-fMRI-EEG

Interventions

PET-fMRI-EEGOTHER

Participants perform PET, fMRI, and EEG simultaneously using a MRI compatible EEG cap

EMCSMCSVS/UWScoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Consciousness DisordersComaPersistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersUnconsciousnessBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Wen Jiang

    Xijing Hospital

    STUDY DIRECTOR

Central Study Contacts

Rong Chen

CONTACT

18292575563cmuchenrong@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 28, 2022

Study Start

September 1, 2022

Primary Completion

April 1, 2023

Study Completion

October 1, 2023

Last Updated

September 28, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)