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

NCT ID: NCT01620957

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-10
• Study Completion Date: 2017-07-31

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.

Conditions

Coma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Coma patients

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stein Silva, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inserm, Department of Anesthesiology and Critical Care at the University Teaching Hospital of Toulouse, France

Kader Boulanouar, PhD

Role: STUDY_CHAIR

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

Locations

Institut National de la Santé et de la Recherche Medicale, U825

Toulouse, Haute Garonne, France

Countries

France

References

Peran P, Malagurski B, Nemmi F, Sarton B, Vinour H, Ferre F, Bounes F, Rousset D, Mrozeck S, Seguin T, Riu B, Minville V, Geeraerts T, Lotterie JA, Deboissezon X, Albucher JF, Fourcade O, Olivot JM, Naccache L, Silva S. Functional and Structural Integrity of Frontoparietal Connectivity in Traumatic and Anoxic Coma. Crit Care Med. 2020 Aug;48(8):e639-e647. doi: 10.1097/CCM.0000000000004406.

Reference Type: RESULT

PMID: 32697504 (View on PubMed)

Rosazza C, Sattin D, Sebastiano DR, Minati L, Leonardi M, Silva S. Disruption of posteromedial large-scale neural communication predicts recovery from coma. Neurology. 2016 Jul 5;87(1):120-1. doi: 10.1212/WNL.0000000000002853. No abstract available.

Reference Type: RESULT

PMID: 27378806 (View on PubMed)

Other Identifiers

2012-A00009-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

C11-55 Inserm

Identifier Type: -

Identifier Source: org_study_id