Functional Connectivity Measurement After Severe Traumatic Brain Injury

Disorder of Consciousness Clinical Trial

— Connectivite  

Official title:

Functional Connectivity Measurement After Severe Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647996
• Other study ID #: 2014-A01873-44
• Status: Completed
• Start date: March 2015
• Est. completion date: October 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Consciousness Disorders
• Disorder of Consciousness

Intervention

Procedure:
• MRI: functional (resting state) and structural (DTI)
One hour brain MRI recording without active task for the patient, no sedation

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

Achard S, Delon-Martin C, Vértes 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	consciousness level measured with Coma recovery scale -revised (CRS-R)		day 60 after first MRI
Secondary	cortical functional connectivity change		connectivity index change (measured on MRI done day 60 after first MRI and compared to MRI done on day 0
Secondary	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)
Secondary	structural connectivity	fibers density between region of interest by DTI	DTI At discharge from intensive care unit (ICU) (30 days post-TBI on average)
Secondary	structural connectivity	fibers density between region of interest by DTI	DTI day 60 after first MRI