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Disorder of ConsciousnessConnectiviteNCT02647996

Functional Connectivity Measurement After Severe Traumatic Brain Injury

An observational study of Disorder of Consciousness, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Disorder of Consciousness
What is being tested?
MRI: functional (resting state) and structural (DTI)
Type of treatment
Surgery or procedure
How many people
34 participants
Where
1 siteFrance
Study dates
Mar 2015to Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: severe TBI admitted in ICU and ready to be discharged to rehabilitation with or without DOC

Who may be able to join

  • 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

Who cannot join

  • age < 18
  • contra indication to MRI
  • consent refusal from the family
  • neurological trouble before TBI
  • patient protected by law

Trial locations and contacts

1 site in 1 country.

France1 site

  • Grenoble University Hospital

    Grenoble

Other trials in France

About this study

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

Read the 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.

Being tested
MRI: functional (resting state) and structural (DTI)
Medical subject headings
Consciousness Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI: functional (resting state) and structural (DTI)Procedure or surgery

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

Study groups in NCT02647996
Study groupRoleWhat they receive
Conscious patientsgroup: TBI patients awoken from comatose state with normal level of consciousness. intervention: fMRI (resting state) and structural (DTI)
Receives: Procedure: MRI: functional (resting state) and structural (DTI)
DOC patientsgroup: TBI patients awoken from comatose state with abnormal level of consciousness intervention: fMRI (resting state) and structural (DTI)
Receives: Procedure: MRI: functional (resting state) and structural (DTI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cortical functional connectivity

    the index is calculated from methodology of the article cited below (2)

    Measured: 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 outcomes (6)

  1. consciousness level measured with Coma recovery scale -revised (CRS-R)

    Measured: 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)

    Measured: day 60 after first MRI

  3. cortical functional connectivity change

    Measured: 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

    Electroencephalographic recording on 12 consecutive hours by night

    Measured: EEG at discharge from intensive care unit (ICU) (30 days post-TBI on average)

  5. structural connectivity

    fibers density between region of interest by DTI

    Measured: DTI At discharge from intensive care unit (ICU) (30 days post-TBI on average)

  6. structural connectivity

    fibers density between region of interest by DTI

    Measured: DTI day 60 after first MRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionJul 2018
  4. Study completionOct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02647996
Sponsor's protocol ID
2014-A01873-44
Acronym
Connectivite
Status last verified
Mar 2020
First submitted
26 Feb 2015
Last updated
20 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21663544

  • 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.

    PubMed 23185007

Questions about this trial

What is this clinical trial studying?

An observational study of Disorder of Consciousness, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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")). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02647996, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.

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