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

NCT07177755 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-17

No results posted yet for this 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.

Conditions

  • Anoxic Coma
  • Cardiac Arrest (CA)
  • Anoxia-Ischemia, Brain
  • Coma

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • National Research Agency, France

    collaborator OTHER
  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • University Hospital, Toulouse

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2028-09-30
Completion
2029-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07177755 on ClinicalTrials.gov