Clinical trial NCT01620957: Longitudinal Study of the Default-mode Network Connectivity in Brain Injured Patients Recovering From Coma
Official title: Analyse de l'activité cérébrale intrinsèque Pendant le Coma et Lors du Retour à la Conscience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coma
Keywords: Default-mode network
Difussion tensor imaging
Cortical thickness
Coma
Vegetative state
Minimally conscious state
Neural correlate of consciousness
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Toulouse
name: Association des Traumatisés du Crane et de la Face, Paris, France
First posted: 2012-06-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of DMN resting state fMRI connectivity between 1 and 2 month after severe brain injury
timeFrame: 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*)
Secondary outcomes:
measure: Compare functional and structural DMN connectivity between 1 and 2 month after severe brain injury
timeFrame: 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*)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut National de la Santé et de la Recherche Medicale, U825
state: Haute Garonne
Study officials:
affiliation: Inserm, Department of Anesthesiology and Critical Care at the University Teaching Hospital of Toulouse, France
name: Stein Silva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Kader Boulanouar, PhD
role: STUDY_CHAIR
References: