NCT02647996

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

February 26, 2015

Last Update Submit

March 19, 2020

Conditions

Disorder of Consciousness

Outcome Measures

Primary Outcomes (1)

  • cortical functional connectivity

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

    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)

  • 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)

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

    day 60 after first MRI

  • cortical functional connectivity change

    connectivity index change (measured on MRI done day 60 after first MRI and compared to MRI done on day 0

  • Slow wave sleep quantification

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

  • structural connectivity

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

  • +1 more secondary outcomes

Study Arms (2)

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)

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)

Interventions

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

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

Conscious patientsDOC patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

Grenoble, France

Location

Related Publications (2)

  • 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.

    PMID: 21663544BACKGROUND

  • 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.

    PMID: 23185007BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Lydia Oujamaa, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

January 6, 2016

Study Start

March 1, 2015

Primary Completion

July 1, 2018

Study Completion

October 1, 2019

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

FR(1)