Status:
COMPLETED
Brain Network Disruptions Related to Traumatic Coma
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Traumatic Coma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable...
Detailed Description
So far, the gold standard for neuroprognostication of severe traumatic brain injury (TBI) or anoxic encephalopathy is the bedside behavioural evaluation. Nevertheless, the predictive value of such an ...
Eligibility Criteria
Inclusion
- Inclusion criteria for patients:
- Male or female / age between 18 to 75 years.
- Coma of traumatic or anoxic aetiology (GCS \< 10).
- Early (\< 1 month after TBI) and after the complete withdrawal of sedative agents.
- Written agreement for participation (legal responsible).
- Inclusion criteria for controls:
- Male or female / age between 18 to 75 years, paired with patients (gender and age).
- Written agreement for participation
- Exclusion criteria:
- Patients without public insurance regime.
- Pregnancy.
- Specific contraindication to the use of MRI (metallic material) or PET (specific allergy related to the ligand).
- Exclusion criteria for controls:
- \- pharmacological treatments which could interfere with consciousness (left to the judgement of the investigator)
Exclusion
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2022
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03482115
Start Date
March 7 2018
End Date
February 7 2022
Last Update
May 31 2024
Active Locations (1)
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1
Hospital
Toulouse, France, 31059