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New treatment option for Coma, Traumatic
Official title Dopaminergic Disruption Induced by Traumatic Coma: Dopaminergic Pathways Abnormalities and Biomarkers of Recovery Using MRI and 18F-LBT-999 PET
ClinicalTrials.gov ID: NCT06930261
What this study is testing
What is LBT-999?
LBT-999 is an investigational medicine, being studied as a potential treatment for coma, traumatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The neural correlates of consciousness have been studied at the macroscopic level. However, the neurochemical basis of these processes remains poorly understood.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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) \<...
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.