An interventional study of advanced whole-brain sMRI/fMRI/contrast-enhanced MRI scan in Coma, Cardiac Arrest and Disorder of Consciousness, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Diagnostic
To assess the performance of a predictive model resulting from the analysis of sMRI/fMRI/contrast-enhanced MRI-derived personalized connectomic data, as compared with standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict anoxoischemic coma neurological outcome at 6 months.
There is a major need for timely, reliable and generalizable methods to predict outcomes in anoxo-ischemic coma patients. Standard predictors of poor outcome after cardiac arrest (CA) include clinical, electrophysiological and serum biomarkers data. All have substantial limitations in terms of reliability and generalizability. By providing whole-brain structural and functional connectivity maps, or connectomes, advanced MRI techniques have precisely revealed the brain network damages induced by CA. Because these individualized connectomic profiles contains critical information about consciousness recovery potential after CA, it can be hypothesized that these whole-brain quantitative data can be used to elaborate highly performant predictive algorithms for anoxo-ischemic coma patients.
Regarding advanced structural MRI (sMRI), two recent studies, including one from the investigators group, have shown a high sensitivity and specificity of these advanced techniques (diffusion tensor imaging -DTI; voxel-based morphometry -VBM) for predicting poor neurological recovery in anoxo-ischemic patients. However, these two studies collected data using poorly defined time window for MRI, across lengthy data collection periods (> 8 years) and did not apply a strict protocol of withdrawal or limitation-of-care decision to control from misclassification of outcome due to so-called selffulfilling prophecies. Concerning functional MRI (fMRI), a recent study from the investigators group reports that the strength of frontoparietal functional connectivity differs between anoxo-ischemic coma patients who recover and those who eventually score an unfavorable outcome at 3 months.
Furthermore, converging evidence suggest that task-based fMRI can be used to detect active, command-following modulation of cortical activity and, hence, consciousness in behaviorally unresponsive patients. This task-based fMRI pattern named Cognitive Motor Dissociation (CMD) show promise of radically improving good outcome neuroprognostication after CA. Finally, aiming to maximize the performance of MRI-derived predictive models, the investigators group have recently reported in a " proof-of-concept " study that a combined sMRI/fMRI connectomes and contrast-enhanced MRI data analysis, synergistically outperform alternative predictive models based on sMRI or fMRI data in isolation.
As recommended in recent guidelines for the management of anoxo-ischemic coma patients[7-9], a standard multimodal prognostication procedure will be followed, including the collection of standard predictors after at least 72h from complete withdrawal of sedation in normothermia condition: i) clinical examination and behavioral data (Day 1, 3 and 7 after inclusion): Glasgow Coma Scale - GCS, Full Outline of UnResponsiveness - FOUR, Coma Recovery Scale Revised - CRSR; and standardized brainstem reflex testing (FOUR, Glasgow-Liège score); ii) severity stratification scoring (Day 1 after inclusion): Cardiac Arrest Hospital Prognosis - CAHP, Out-of-Hospital Cardiac Arrest - OHCA, iii) laboratory findings (Day 1, 3 and 7 after inclusion) : NSE blood level (Day 1); iv) electrophysiological assessments: standard EEG using ACNS classification (once between Day 1 and Day 15 after inclusion); v) standard neuroimaging (once between Day 1 and Day 15 after inclusion): standard brain CT or MRI data (T1, T2*, SWI, DWI, FLAIR).
In addition to standard clinical neuroprognostication procedure, an advanced whole-brain sMRI/fMRI/contrast-enhanced MRI scan will be acquired at least after 72h from complete withdrawal of sedation in normothermia condition (between Day 1 and Day 7 after inclusion).
sMRI/fMRI/ contrast-enhanced MRI data will be collected during the same scanning plot that will be used for standard MRI (T1, T2*, SWI, DWI, FLAIR) will encompass (total acquisition time = 45 min for all centers, except for Toulouse center = 60 min):
To gauge the clinical significance of this findings, the investigators plan to use largely validated neurological functional score (mRS, CPCs). Additionally, the investigator plan to explore as secondary evaluation criteria patients' level of consciousness (CRS-R) and the restauration of the pre-arrest health-related quality of life (HRQOL). These assessments will be performed at hospital discharge (mRS, CPC) and at 3 (mRS, CPC) and 6 months (mRS, CPC, CRS-R, HRQOL) after CA by specifically trained investigators, during the planned follow-up visit. Patient's medical care will be not be influenced by patient's study participation because the treating teams will be fully blinded to advanced sMRI/fMRI/contrast-enhanced MRI data (Figure 3). Patient's management will be performed in agreement with international guidelines. A strict and homogenous WLST protocol will be used in all the recruiting centers.
138 studies on the registry are indexed under Coma; 35 are open to participants now.
This study's planned enrollment of 263 is above the median of 85 across 77 interventional studies indexed under Coma.
Browse Coma studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard multimodal prognostication procedure will be followed, including the collection of standard predictors: i) clinical examination and behavioral data (Day 1, 3 and 7 after inclusion): Glasgow Coma Scale - GCS, Full Outline of UnResponsiveness - FOUR,Coma Recovery Scale Revised - CRS-R; and standardized brainstem reflex testing (FOUR, Glasgow-Liège score); ii) severity stratification scoring (Day 1 after inclusion): Cardiac Arrest Hospital Prognosis - CAHP, Out-of-Hospital Cardiac Arrest - OHCA, iii) laboratory findings (Day 1) : NSE blood level iv) electrophysiological assessments (once between Day 1 and Day 15 after inclusion): standard EEG following current guidelines and using ACNS classification; v) standard neuroimaging (once between Day 1 and Day 15 after inclusion): standard brain CT or MRI data (T1, T2\*, SWI, DWI, FLAIR). An advanced wholebrain sMRI/fMRI/contrast-enhanced MRI scan will be acquired (between Day 1 and Day 7 after inclusion).
Other: advanced whole-brain sMRI/fMRI/contrast-enhanced MRI scan
advanced whole-brain sMRI/fMRI/contrast-enhanced MRI scan (estimated total scanning time = 45 min for all centers except for Toulouse = 60min) will be acquired at least after 72h from complete withdrawal of sedation in normothermia condition (between Day 1 and Day 7 after inclusion).
performance of a predictive model to predict 6 months neurological outcome
Comparison between the area under the Receiver Operating Characteristic (ROC) curves of outcomes prediction models, based on either MRI-derived indicators (structural, functional and contrast-enhanced MRI), or built upon standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) both collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict 6 months neurological outcome as measured by the dichotomized Rankin Scale (mRS).
Time frame: month 6
Performance of a predictive model to predict neurological outcome at hospital discharge
Comparison between the area under the Receiver Operating Characteristic (ROC) curves of outcomes prediction models, based on either MRI-derived indicators (structural, functional and contrast-enhanced MRI) or built upon standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) both collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict neurological outcome at hospital discharge after CA by the dichotomized Rankin Scale (mRS).
Time frame: Hospital discharge
Performance of a predictive model to predict neurological outcome at 3 months after CA
Comparison between the area under the Receiver Operating Characteristic (ROC) curves of outcomes prediction models, based on either MRI-derived indicators (structural, functional and contrast-enhanced MRI) or built upon standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) both collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict neurological outcome at 3 months after CA by the dichotomized Rankin Scale (mRS).
Time frame: month 3
Plan to share: No
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