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Assessment of Structural Brain Changes Related to Anoxic Coma Using High-field and Very Low Field Mobile MRI

NCT07177755 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-09-15
Last updated
2025-09-17

Condition(s) studied

Anoxic ComaCardiac Arrest (CA)Anoxia-Ischemia, BrainComa

Investigational drug(s) / intervention(s)

High-field and very-low-field MRI acquisitions

High-field and very-low-field MRI acquisitions: MRI will be early acquired, as soon as possible after patient hospital admission and always in coma state for patients. For both patients and controls each MRI scanning session will encompass pairs of HF and VLF MRI acquisitions, that will be collected the same day. The main MRI sequences will be: T1, T2, FLAIR and DWI. The VLF spatial resolution recommended by the constructor for all these sequences correspond to voxel size is around 1.5mm/1.5mm/5mm. The total brain scanning time is estimated at 30 minutes.

Study summary

Standard predictors of outcome after cardiac arrest (CA) have substantial limitations in terms of reliability and generalizability. By providing brain structural connectivity maps, or connectomes, advanced MRI techniques, operating through high-strength magnetic field (HF; 1.5 to 3-T), have precisely revealed white and grey brain matter damages induced by CA, and have demonstrated the high sensitivity and specificity of these indicators for predicting neurological outcome after CA. However, HF MRI requires rigid safety precautions, highly trained technicians and patient transport to dedicated hospital imaging suites, hindering the implementation of these promising neuroimaging techniques in the setting of critical illness.

Interestingly, a recent report demonstrates the capability of a proof-of-concept very low-field (VLF; 0.064-T) mobile MRI to obtain neuroimaging at the bedside in critically ill patients. Nevertheless, the spatial resolution of VLF-MRI seems low and there is no available evidence about the use of VLF-MRI to extract highly needed new predictors of neurological recovery based on critical brain structural connectomes.

The CUBE project holds the promise of providing a radical paradigm shift in the field of neuroprognostication of anoxic coma patients. The current proposal is a "proof-of concept" study which aims to compare for the first time, HF, VLF and enhanced VLF (recon-VLF) structural connectomes from anoxic coma patients and healthy subjects across the time (3 paired HF and VLF brain scan across the first two weeks after CA). To obtain recon-VLF data, the Investigators will use an ensemble of ground-breaking methods to increase the native spatial resolution of VLF-MRI data. The whole brain imaging dataset will be used to prepare future neuroprognostication studies based on fully bedside assessment of brain structural integrity after CA.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion criteria : COMA PATIENTS * 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. * Written informed consent from patient's legal representative. * Affiliation to the French social security system HEALTHY VOLUNTEERS * Adult patients (male or female ≥ 18 years). * Written informed consent. * Affiliation to the French social security system Exclusion criteria : COMA PATIENTS * Brain death. * Coma explained by other cause than CA. * Pregnancy. * MRI contraindication: medical material not MRI compatible. * Hemodynamic instability or respiratory failure precluding patient's transport and MRI scanning. HEALTHY VOLUNTEERS * Pregnancy. * MRI contraindication: medical material not MRI compatible. * Volunteers who do not wish to be informed of an abnormality detected on MRI a posteriori

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU de Toulouse Toulouse France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07177755 on ClinicalTrials.gov ↗ ← All trials in France