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RecruitingNCT06617377ARISEUpdated Jun 29, 2026

Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest

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

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
263
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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):

  • Structural MRI (total acquisition time = 30 min): i) gray matter: 3D T1-weithed data will be computed to assess whole brain cortical thickness and deep gray matter quantitative volumetry, ii) white matter, whole-brain DTI will be acquired to measure whole brain with matter fractional anisotropy (WWM-FA) and mean average diffusion coefficient (WB-aDC). A normalization procedure will be applied (healthy controls data from each neuroimaging facility).
  • Functional MRI (total acquisition time = 10 min for all centers, except for Toulouse center = 25 min): i) passive-task: multislice T2*-weighted for resting-state fMRI analysis images, acquisition time = 10 min; ii) active tasks: fMRI will be used to probe for volitional thought without selfexpression output (motor imagery and motor action), acquisition time = 15 min (only for Toulouse center).
  • Contrast-enhanced MRI (acquisition time = 5 min) for blood-brain barrier permeability assessment. As exploratory goals and seeking to: i) study the potential changes over time of advanced brain sMRI/fMRI/contrast-enhanced MRI data, a second identical advanced sMRI/fMRI/contrastenhanced MRI will be performed minimum 7 days (with an allowance of + 3 days) after the first MRI assessment in patients enrolled in Toulouse center (N = 30); ii) To investigate the usefulness for patient's neuroprognostication of novel brain injury fluid-derived biomarkers (ref), three peripheral blood samples will be collected two times (each sample blood volume= 5 ml), a first one immediately at patient's inclusion and second one 7 days later (N = 30, only for Toulouse center).

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.

02

Conditions studied

  • Coma
  • Cardiac Arrest
  • Disorder of Consciousness
  • Neurologic Disorder

Keywords

  • prognosis
  • coma
  • cardiac arrest
  • Structural MRI
  • resting-state
  • cognitive motor dissociation
03

In context

Coma

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 →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (male or female ≥ 18 years).
  • Coma, as indicated by a Glasgow Coma Scale (GCS) ≤ 8 (motor score ≤ 2) immediately after CA resuscitation and before sedation onset.
  • Persisting unconsciousness, defined as the inability to obey verbal commands, after at least 72 hours from complete withdrawal of sedation in normothermia conditions.
  • Written from patient's legal representative.
  • Affiliation or beneficiary to the French social security system.

Exclusion criteria

Exclusion Criteria:

  • Brain death.
  • Coma explained by other cause than CA.
  • Likely poor neurological outcome based on early predictors, following ERC-ESCIM 2021 recommendations. In a comatose patient with GCS motor score ≤ 3 at ≥ 72 h from ROSC, in the absence of confounders, the identification of at least two of the following: bilaterally absent pupillary light and corneal reflexes at ≥ 72h, bilaterally absent N20 SSEP ≥ 24h; neuron-specific enolase (NSE) > 60 μg/l at 48h and/or 72h, status myoclonus ≤72h.
  • Decision of WLST previous to patient recruitment, based on early predictors of poor neurological outcome, age, co-morbidity, general organ function and patient's preferences.
  • shorter than 6 months based on pre-morbid conditions.
  • Former neurological functional disability (mRS > 2 before CA).
  • MRI : medical material not MRI compatible, claustrophobia
  • Known to gadoteric acid, meglumin or any drug containing gadolinium
  • Severe kidney failure defined as a KDIGO score > 3 ( \< 30 ml/min/1.73 m2 or renal replacement therapy).
  • Hemodynamic shock or severe respiratory failure precluding patient's transport and MRI scanning.
  • Pregnancy or nursing woman.
  • Patient under juridical protection.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
263 participants (estimated)

Study arms

  • Experimental
    anoxo-ischemic coma patients

    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

Interventions

  • Otheradvanced 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).

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06617377
Responsible party
Sponsor
First posted
Sep 27, 2024
Start date
Mar 16, 2026
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Jun 29, 2026

Study contacts

Stein SILVA, MD PhD
Contact
silva.s@chu-toulouse.fr
0561772288 ext. +33
Stein SILVA, MD PhD
principal investigator · University Hospital of Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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