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

Coma Clinical Trial

— ACI-Coma  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620957
• Other study ID #: C11-55 Inserm
• Secondary ID: 2012-A00009-34
• Status: Completed
• Start date: July 10, 2012
• Est. completion date: July 2017

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coma

Locations

Country	Name	City	State
France	Institut National de la Santé et de la Recherche Medicale, U825	Toulouse	Haute Garonne

Sponsors (3)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Association des Traumatisés du Crane et de la Face, Paris, France, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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*)