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Functional Connectivity Measurement After Severe Traumatic Brain Injury

Functional Connectivity Measurement After Severe Traumatic Brain Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02647996
Acronym
Connectivite
Enrollment
34
Registered
2016-01-06
Start date
2015-03-31
Completion date
2019-10-31
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Consciousness

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

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.

Interventions

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

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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cortical functional connectivityconnectivity 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

MeasureTime frameDescription
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)
cortical functional connectivity changeconnectivity index change (measured on MRI done day 60 after first MRI and compared to MRI done on day 0
Slow wave sleep quantificationEEG at discharge from intensive care unit (ICU) (30 days post-TBI on average)Electroencephalographic recording on 12 consecutive hours by night
structural connectivityDTI At discharge from intensive care unit (ICU) (30 days post-TBI on average)fibers density between region of interest by DTI

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026