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Clinical Trials/NCT03482115
NCT03482115
Completed
Not Applicable

Whole Brain Connectivity Changes Induced by Traumatic Coma: Combined Structural, Functional and Neuroinflammatory Approaches

University Hospital, Toulouse1 site in 1 country59 target enrollmentMarch 7, 2018
ConditionsTraumatic Coma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Coma
Sponsor
University Hospital, Toulouse
Enrollment
59
Locations
1
Primary Endpoint
Matrix of the neuroimaging data in PET examination
Status
Completed
Last Updated
last year

Overview

Brief Summary

To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging approaches encompassing several up-to-date techniques as structural MRI, fMRI and positron emission tomography (PET) scan (neuroinflammation ligands).

Detailed Description

So far, the gold standard for neuroprognostication of severe traumatic brain injury (TBI) or anoxic encephalopathy is the bedside behavioural evaluation. Nevertheless, the predictive value of such an exclusive clinical approach has been consistently reported as limited and insufficient in this challenging clinical setting. Recent theoretical and experimental data converge towards the idea of the critical implication of long-range brain connection in consciousness access and maintain. Nevertheless, previous studies have focused on the specific analysis of some targeted connections (regions of interest), and have used exclusively a single approach in neuroimaging (structural or functional imaging), with no interest in the neuro-inflammatory and neurodegenerative mechanisms likely associated with these disconnection phenomena. So, cerebral disconnection characterization at the level of the whole brain, at different stages of pathological abolition of consciousness must be made, on an anatomical, functional and metabolic scale. This descriptive study represents a first step in the identification of relevant multimodal imaging biomarkers. This will then lead to a larger study to identify the prognostic impact of these different biomarkers obtained in the acute phase of patient management.

Registry
clinicaltrials.gov
Start Date
March 7, 2018
End Date
February 7, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Matrix of the neuroimaging data in PET examination

Time Frame: First Visit, within three days after day 0

neuroinflammation by \[18F\] DPA-714 during PET imaging

Secondary Outcomes

  • Glasgow Coma Scale (GCS)(Inclusion)
  • Coma Recovery Scale Revised (CRS-R)(3 months +/- 3 days after the primary brain insult)
  • FOUR score(3 months +/- 3 days after the primary brain insult)
  • analysis of imaging parameters obtained in MRI(First Visit, within three days after day 0)

Study Sites (1)

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