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Longitudinal Study of the Default-mode Network Connectivity in Brain Injured Patients Recovering From Coma (ACI-Coma)

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ClinicalTrials.gov Identifier: NCT01620957
Recruitment Status : Unknown
Verified April 2015 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : June 15, 2012
Last Update Posted : April 27, 2015
Sponsor:
Collaborators:
University Hospital, Toulouse
Association des Traumatisés du Crane et de la Face, Paris, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

April 11, 2012
June 15, 2012
April 27, 2015
July 2012
July 2017   (Final data collection date for primary outcome measure)
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*) ]
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.
Same as current
Complete list of historical versions of study NCT01620957 on ClinicalTrials.gov Archive Site
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*) ]
Functional DMN connectivity will be investigated using probabilistic independent component analysis. Structural connectivity counterpart, will be assessed by diffusor tensor imaging and cortical thickness.
Same as current
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Longitudinal Study of the Default-mode Network Connectivity in Brain Injured Patients Recovering From Coma
Analyse de l'activité cérébrale intrinsèque Pendant le Coma et Lors du Retour à la Conscience
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
We will analyse DMN functional and anatomical connectivity in severely brain-injured patients in coma and during the first two month following brain injury. All patients will be admitted from one of the four Critical Care Units of University Teaching Hospital of Toulouse, France.
Coma
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Coma patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
153
Same as current
July 2017
July 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Brain-damaged patients in coma (trauma or anoxic origin).
  • Male and female, ranging in age from 18 to 75 years.

Exclusion Criteria:

  • Withdrawal of consent from the patients (or the persons having legal responsibility for them).
  • Sedation or general anaesthesia during assessement period (< 24 hours).
  • MRI contraindications
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01620957
C11-55 Inserm
2012-A00009-34 ( Registry Identifier: IDRCB )
No
Not Provided
Not Provided
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
  • University Hospital, Toulouse
  • Association des Traumatisés du Crane et de la Face, Paris, France
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
Institut National de la Santé Et de la Recherche Médicale, France
April 2015