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

NCT01620957 | Completed

• 2 other identifiers: C11-55 Inserm2012-A00009-34
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

Default-mode network; Difussion tensor imaging; Cortical thickness; Coma; Vegetative state; Minimally conscious state; Neural correlate of consciousness

Outcome Measures

Primary Outcomes (1)

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

  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.

  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 (1)

• Compare functional and structural DMN connectivity between 1 and 2 month after severe brain injury

  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*)

Study Arms (1)

Coma patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• University Hospital, Toulouse: collaborator
• Association des Traumatisés du Crane et de la Face, Paris, France: collaborator

Study Sites (1)

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

Toulouse, Haute Garonne, 31059, France

Location

Related Publications (2)

• 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.

  PMID: 32697504 RESULT

• 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.

  PMID: 27378806 RESULT

MeSH Terms

Conditions

Coma; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Stein Silva, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Kader Boulanouar, PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: June 15, 2012
• Study Start: July 10, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 18, 2025

Record last verified: 2021-08

Locations

FR (1)