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Dopaminergic Disruption Induced by Traumatic Coma: Dopaminergic Pathways Abnormalities and Biomarkers of Recovery Using MRI and 18F-LBT-999 PET

RecruitingPhase 2Ages 18 Years - 65 YearsAllInstitut National de la Santé Et de la Recherche …
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In plain words

What the trial is, and whether it could suit you

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 cortico-centric view of consciousness. It highlights the role of subcortical regulation by dopaminergic circuits, including the ventral tegmental area and striatal loops. Experimental data show the importance of dopamine in consciousness recovery. Animal TBI studies link dopamine deficits to loss of consciousness and recovery. In humans, imaging studies show disrupted dopaminergic networks in chronic consciousness disorders. Yet, early-phase dopaminergic disruptions in acute coma remain underexplored. Molecular imaging with PET or SPECT offers insights into dopamine system disturbances. The novel radiotracer 18F-LBT-999 enables detailed imaging of dopaminergic circuits, providing better spa

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 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 Criteria: 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.
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What it tests

  • LBT-999
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Where

1 site
CHU de Toulouse
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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