Status:
RECRUITING
Dopaminergic Disruption Induced by Traumatic Coma: Dopaminergic Pathways Abnormalities and Biomarkers of Recovery Using MRI and 18F-LBT-999 PET
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Coma, Traumatic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The neural correlates of consciousness have been studied at the macroscopic level. However, the neurochemical basis of these processes remains poorly understood. The mesocircuit theory challenges the ...
Eligibility Criteria
Inclusion
- For All Participants:
- Aged 18-65 years.
- Affiliated with or beneficiary of a social security system.
- Signed informed consent provided by the participant or a trusted representative (for patients).
- For all TBI Participant
- Hospitalized for a non-penetrating traumatic brain injury (TBI) occurring within the last 30 days, with traumatic coma (Glasgow Coma Scale (GCS) \< 10 and motor score (M) \< 6) at hospital admission.
- Sedative treatments discontinued for more than 48 hours.
- Clinically stable (no hemodynamic, respiratory, or metabolic instability requiring specific interventions that contraindicate medical transfer to the imaging center).
- For the TBI-COMA Group:
- \- Severe TBI characterized by prolonged coma, defined as an initial GCS \< 10 with M \< 6, and no recovery of consciousness at inclusion (GCS \< 10 with M \< 6).
- For the TBI-REC Group:
- Severe TBI characterized by prolonged coma, defined as an initial GCS \< 10 with M \< 6, with recovery of consciousness evidenced by simple command-following (GCS ≥ 10 with M = 6) at inclusion.
- For Healthy Controls:
- Matched by age (± 2 years) and sex to patients in the TBI-COMA group.
Exclusion
- For All Participants:
- Pregnant or breastfeeding women
- Contraindications to MRI
- Known allergy to the PET radiotracer or its excipients.
- History of conditions affecting the dopaminergic system
- Individuals under legal protection measures
- Current treatment with dopaminergic agonists or antagonists.
- For Patients Only:
- Coma due to causes other than TBI.
- Decompressive craniectomy resulting in anatomical alterations incompatible with standardized image analysis (e.g., midline shift \> 2 cm).
- For Healthy Controls Only:
- Women of childbearing potential without effective contraception.
- Women unwilling to maintain effective contraception during the 30-day study period.
Key Trial Info
Start Date :
January 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06930261
Start Date
January 14 2025
End Date
September 1 2028
Last Update
April 16 2025
Active Locations (1)
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1
CHU de Toulouse
Toulouse, France