Functional Connectivity Measurement After Severe Traumatic Brain Injury

Study Overview
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Brief Summary
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To compare functional connectivity after severe traumatic brain injury (TBI) between a group of post-comatose TBI with restored consciousness and a group of post-comatose TBI with persistant disorder of consciousness at admission in rehabilitation

Detailed Description
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Recovery of consciousness can be impaired in severe traumatic brain injury (TBI). Prognostic factors are sparse and mostly clinical (mainly the initial Glasgow coma scale GCS) (1). Functional magnetic resonance imaging (fMRI) could allow a better understanding of functional recovery. Graph method has been applied to fMRI signal analysis in disorder of consciousness (DOC) due to post-anoxic encephalopathy. Comatose state was characterized by dramatic change in local connectivity (hub location) without significant change in global connectivity (2). The present study aims at describing functional connectivity in DOC following severe TBI. We will record resting state fMRI in TBI patients in two clinical conditions: conscious state versus DOC state.

Official Title
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Functional Connectivity Measurement After Severe Traumatic Brain Injury

Conditions
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Disorder of Consciousness

Intervention / Treatment
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* Procedure: MRI: functional (resting state) and structural (DTI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe TBI no general anesthesia since 7 days no neuroleptic nor hypnotic drug since 3 days medical criteria fulfilled to be discharged from ICU medical insurance Exclusion Criteria: age < 18 contra indication to MRI consent refusal from the family neurological trouble before TBI patient protected by law

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conscious patients<br>group: TBI patients awoken from comatose state with normal level of consciousness. intervention: fMRI (resting state) and structural (DTI) | Procedure: MRI: functional (resting state) and structural (DTI)<br>* One hour brain MRI recording without active task for the patient, no sedation<br>|
| DOC patients<br>group: TBI patients awoken from comatose state with abnormal level of consciousness intervention: fMRI (resting state) and structural (DTI) | Procedure: MRI: functional (resting state) and structural (DTI)<br>* One hour brain MRI recording without active task for the patient, no sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cortical functional connectivity | the index is calculated from methodology of the article cited below (2) | connectivity index measured on MRI recorded at discharge from intensive care unit (ICU) (30 days post-TBI on average) and compared between the two groups of patients (group normal level of consciousness versus group disorder of consciousness) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consciousness level measured with Coma recovery scale -revised (CRS-R) |  | CRS-R score at discharge from intensive care unit (ICU) (30 days post-TBI on average) | 
| consciousness level measured with Coma recovery scale -revised (CRS-R) |  | day 60 after first MRI | 
| cortical functional connectivity change |  | connectivity index change (measured on MRI done day 60 after first MRI and compared to MRI done on day 0 | 
| Slow wave sleep quantification | Electroencephalographic recording on 12 consecutive hours by night | EEG at discharge from intensive care unit (ICU) (30 days post-TBI on average) | 
| structural connectivity | fibers density between region of interest by DTI | DTI At discharge from intensive care unit (ICU) (30 days post-TBI on average) | 
| structural connectivity | fibers density between region of interest by DTI | DTI day 60 after first MRI |