Clinical trial NCT02647996: Functional Connectivity Measurement After Severe Traumatic Brain Injury
Official title: Functional Connectivity Measurement After Severe Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Consciousness
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: severe TBI admitted in ICU and ready to be discharged to rehabilitation with or without DOC

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.

Eligibility criteria: 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

Primary outcomes:
measure: cortical functional connectivity
timeFrame: 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 outcomes:
measure: consciousness level measured with Coma recovery scale -revised (CRS-R)
timeFrame: CRS-R score at discharge from intensive care unit (ICU) (30 days post-TBI on average)
measure: consciousness level measured with Coma recovery scale -revised (CRS-R)
timeFrame: day 60 after first MRI
measure: cortical functional connectivity change
timeFrame: connectivity index change (measured on MRI done day 60 after first MRI and compared to MRI done on day 0
measure: Slow wave sleep quantification
timeFrame: EEG at discharge from intensive care unit (ICU) (30 days post-TBI on average)
measure: structural connectivity
timeFrame: DTI At discharge from intensive care unit (ICU) (30 days post-TBI on average)
measure: structural connectivity
timeFrame: DTI day 60 after first MRI
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Lydia Oujamaa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakase-Richardson R, Whyte J, Giacino JT, Pavawalla S, Barnett SD, Yablon SA, Sherer M, Kalmar K, Hammond FM, Greenwald B, Horn LJ, Seel R, McCarthy M, Tran J, Walker WC. Longitudinal outcome of patients with disordered consciousness in the NIDRR TBI Model Systems Programs. J Neurotrauma. 2012 Jan 1;29(1):59-65. doi: 10.1089/neu.2011.1829. Epub 2011 Aug 4.
citation: Achard S, Delon-Martin C, Vertes PE, Renard F, Schenck M, Schneider F, Heinrich C, Kremer S, Bullmore ET. Hubs of brain functional networks are radically reorganized in comatose patients. Proc Natl Acad Sci U S A. 2012 Dec 11;109(50):20608-13. doi: 10.1073/pnas.1208933109. Epub 2012 Nov 26.