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

Completed

• Conditions: Coma

• Registration Number: NCT01620957
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Study Start: 2012-07-10
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of DMN resting state fMRI 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*)	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.

Secondary Outcome Measures

Name	Time	Method
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*)	Functional DMN connectivity will be investigated using probabilistic independent component analysis. Structural connectivity counterpart, will be assessed by diffusor tensor imaging and cortical thickness.

Trial Locations

Locations (1)

Institut National de la Santé et de la Recherche Medicale, U825; 🇫🇷 Toulouse, Haute Garonne, France