Connectivite: Functional Connectivity Measurement After Severe Traumatic Brain Injury

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT02647996
Collaborator
(none)
34
1
55
0.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: MRI: functional (resting state) and structural (DTI)

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 Design

Study Type:
Observational
Actual Enrollment :
34 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Functional Connectivity Measurement After Severe Traumatic Brain Injury
Actual Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Conscious patients

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)
One hour brain MRI recording without active task for the patient, no sedation

DOC patients

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)
One hour brain MRI recording without active task for the patient, no sedation

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)]

  2. consciousness level measured with Coma recovery scale -revised (CRS-R) [day 60 after first MRI]

  3. cortical functional connectivity change [connectivity index change (measured on MRI done day 60 after first MRI and compared to MRI done on day 0]

  4. 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

  5. structural connectivity [DTI At discharge from intensive care unit (ICU) (30 days post-TBI on average)]

    fibers density between region of interest by DTI

  6. structural connectivity [DTI day 60 after first MRI]

    fibers density between region of interest by DTI

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grenoble University Hospital Grenoble France

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Lydia Oujamaa, MD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02647996
Other Study ID Numbers:
  • 2014-A01873-44
First Posted:
Jan 6, 2016
Last Update Posted:
Mar 20, 2020
Last Verified:
Mar 1, 2020

Study Results

No Results Posted as of Mar 20, 2020