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

NCT01620957 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Coma

Sponsors & Collaborators

  • University Hospital, Toulouse

    collaborator OTHER

  • Association des Traumatisés du Crane et de la Face, Paris, France

    collaborator UNKNOWN

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Stein Silva, MD, PhD · Inserm, Department of Anesthesiology and Critical Care at the University Teaching Hospital of Toulouse, France

  • Kader Boulanouar, PhD · Institut National de la Santé Et de la Recherche Médicale, France

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-10
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01620957 on ClinicalTrials.gov