Longitudinal Study of the Default-mode Network Connectivity in Brain Injured Patients Recovering From Coma (ACI-Coma)
Several studies in healthy volunteers have suggested that the synchronized functional connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and when required, a switch in the activity between the DMN and other networks involved in specific congnitive functions, would occur. This interaction permit to make the hypothesis, that baseline brain activity is likely to shape our ongoing " stream of consciousness " and could correlate with conscious perception. The investigators hypothesized that DMN connectivity strength would be related to the level of consciousness of brain-damaged patients. The investigators will follow severely brain-injured patient in coma. Clinical examination using standardized behavioural scales: FOUR score (Full Outline of UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30 (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state between 30 and 60 days, an additional clinical and brain imaging assessment will be performed to identify related changes in brain activity (visit 1*) Monitoring of vital parameters will be performed in patients by a senior anaesthesiologist throughout the experiment.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Analyse de l'activité cérébrale intrinsèque Pendant le Coma et Lors du Retour à la Conscience|
- Change of DMN resting state fMRI connectivity between 1 and 2 month after severe brain injury [ Time Frame: VISIT1 = coma state (an expected average of 3 to 30 days after brain injury), VISIT2 = recovery phase (an expected average of 30 to 60 days). Finally, in case of full recovery during the recovery phase an additional assessment will be performed (VISIT1*) ] [ Designated as safety issue: No ]To date, the functional significance of DMN resting state connectivity patterns remain unclear. We hypothesized that DMN connectivity strength would be related to the level of consciousness of non-communicative brain-damaged patients, as assessed by standardized behavioural scales (FOUR score, CRS-R). Furthermore, we expected that a disruption of functional connectivity in the DMN could predict brain-damaged patient's recovery.
- Compare functional and structural DMN connectivity between 1 and 2 month after severe brain injury [ Time Frame: VISIT1 = coma state (an expected average of 3 to 30 days after brain injury), VISIT2 = recovery phase (an expected average of 30 to 60 days). Finally, in case of full recovery during the recovery phase an additional assessment will be performed (VISIT1*) ] [ Designated as safety issue: No ]Functional DMN connectivity will be investigated using probabilistic independent component analysis. Structural connectivity counterpart, will be assessed by diffusor tensor imaging and cortical thickness.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620957
|Contact: Stein Silva, MD, PhD||+33(0)email@example.com|
|Contact: Kader Boulanouar, PhD||+33(0)firstname.lastname@example.org|
|Institut National de la Santé et de la Recherche Medicale, U825||Recruiting|
|Toulouse, Haute Garonne, France, 31059|
|Sub-Investigator: Isabelle Loubinoux, PhD|
|Sub-Investigator: Patrice Peran, PhD|
|Principal Investigator:||Stein Silva, MD, PhD||Inserm, Department of Anesthesiology and Critical Care at the University Teaching Hospital of Toulouse, France|
|Study Chair:||Kader Boulanouar, PhD||Institut National de la Santé Et de la Recherche Médicale, France|