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Functional Connectivity Measurement After Severe Traumatic Brain Injury (Connectivite)

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ClinicalTrials.gov Identifier: NCT02647996
Recruitment Status : Unknown
Verified April 2017 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : January 6, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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
Disorder of Consciousness 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.

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Study Type : Observational
Estimated Enrollment : 34 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional Connectivity Measurement After Severe Traumatic Brain Injury
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. cortical functional connectivity [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: day 60 after first MRI ]
  3. cortical functional connectivity change [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: DTI day 60 after first MRI ]
    fibers density between region of interest by DTI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
severe TBI admitted in ICU and ready to be discharged to rehabilitation with or without DOC
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647996


Contacts
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Contact: Lydia Oujamaa, MD 0033476767374

Locations
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France
Grenoble University Hospital Recruiting
Grenoble, France
Contact: Lydia Oujamaa, MD    0033476767374      
Sponsors and Collaborators
University Hospital, Grenoble

Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02647996     History of Changes
Other Study ID Numbers: 2014-A01873-44
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Consciousness Disorders
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders