Functional Connectivity Measurement After Severe Traumatic Brain Injury

NCT ID: NCT02647996

Last Updated: 2020-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-10-31

Brief Summary

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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

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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.

Conditions

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Disorder of Consciousness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Conscious patients

group: TBI patients awoken from comatose state with normal level of consciousness.

intervention: fMRI (resting state) and structural (DTI)

MRI: functional (resting state) and structural (DTI)

Intervention Type PROCEDURE

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)

MRI: functional (resting state) and structural (DTI)

Intervention Type PROCEDURE

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

Interventions

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MRI: functional (resting state) and structural (DTI)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lydia Oujamaa, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Grenoble University Hospital

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 21663544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23185007 (View on PubMed)

Other Identifiers

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2014-A01873-44

Identifier Type: -

Identifier Source: org_study_id

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