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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01620957
Acronym
ACI-Coma
Enrollment
43
Registered
2012-06-15
Start date
2012-07-10
Completion date
2017-07-31
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coma

Keywords

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

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of DMN resting state fMRI connectivity between 1 and 2 month after severe brain injuryVISIT1 = 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

MeasureTime frameDescription
Compare functional and structural DMN connectivity between 1 and 2 month after severe brain injuryVISIT1 = 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026