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

Coma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Coma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Coma patients

Study Status

Unknown status

Start Date: July 2012

Completed Date: July 2017

Phase: N/A

Type: Observational

Design:

Primary Outcome: Change of DMN resting state fMRI connectivity between 1 and 2 month after severe brain injury

Secondary Outcome: Compare functional and structural DMN connectivity between 1 and 2 month after severe brain injury

Study sponsors, principal investigator, and references

Principal Investigator: Stein Silva, MD, PhD

Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Collaborator: University Hospital, Toulouse

More information:https://clinicaltrials.gov/show/NCT01620957

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