Functional Connectivity Measurement After Severe Traumatic Brain Injury (Connectivite)

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

Study Overview

• Status: Completed
• Conditions: Disorder of Consciousness
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

severe TBI admitted in ICU and ready to be discharged to rehabilitation with or without DOC

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Consciousness Disorders
• Other Study ID Numbers: 2014-A01873-44