Functional Connectivity Measurement After Severe Traumatic Brain Injury

Completed

• Conditions: Disorder of Consciousness

• Registration Number: NCT02647996
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-02-26
• Study Start: 2015-03
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Primary Completion: 2018-07
• Study Completion: 2019-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cortical functional connectivity	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")	the index is calculated from methodology of the article cited below (2)

Secondary Outcome Measures

Name	Time	Method
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	EEG at discharge from intensive care unit (ICU) (30 days post-TBI on average)	Electroencephalographic recording on 12 consecutive hours by night
structural connectivity	DTI day 60 after first MRI	fibers density between region of interest by DTI

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble, France