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Completed

NCT Number: NCT02647996

Functional Connectivity Measurement After Severe Traumatic Brain Injury

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

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Key information

Conditions

Disorder of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grenoble University Hospital

Grenoble, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: Connectivite

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jan 6, 2016
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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