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

Analyse de l'activité cérébrale intrinsèque Pendant le Coma et Lors du Retour à la Conscience

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.

Study Overview

• Status: Completed
• Conditions: Coma

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• France
  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31059
      • Institut National de la Santé et de la Recherche Medicale, U825

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Coma patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare functional and structural DMN connectivity between 1 and 2 month after severe brain injury	Functional DMN connectivity will be investigated using probabilistic independent component analysis. Structural connectivity counterpart, will be assessed by diffusor tensor imaging and cortical thickness.	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*)

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: University Hospital, Toulouse; Association des Traumatisés du Crane et de la Face, Paris, France
• Investigators: Principal Investigator: Stein Silva, MD, PhD, Inserm, Department of Anesthesiology and Critical Care at the University Teaching Hospital of Toulouse, France; Study Chair: Kader Boulanouar, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2012
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: April 11, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (Estimated): June 15, 2012

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Coma; Vegetative state; Minimally conscious state; Default-mode network; Difussion tensor imaging; Cortical thickness; Neural correlate of consciousness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Brain Damage, Chronic; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Persistent Vegetative State; Coma
• Other Study ID Numbers: C11-55 Inserm; 2012-A00009-34 (Registry Identifier: IDRCB)