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Dopaminergic disruption induced by traumatic coma: multimodal neuroimaging approaches to characterize dopaminergic pathways abnormalities and biomarkers of recovery using the [18F]LBT-999 radiotracer.
EU CTIS ID: 2023-504893-39-00
What this study is testing
To characterize metabolic abnormalities of the dopaminergic network within the striatum in comatose patients with severe traumatic brain (TC-COMA group) injury using the radiotracer [18F]LBT-999.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For all participants: Female or male between 18 and 65 years of age
- For all participants: Affiliation with a social security scheme or beneficiary of such a scheme.
- For all participants: Informed consent signed by the participant or by the trusted person (for patients)
- For all patients: Patient admitted to hospital, victim of non-penetrating TBI occurring within <30 days: traumatic coma (GCS < 10 with M < 6) on hospital admission.
- For all patients: Discontinuation of sedative treatments for more than 48 hours
- For all patients: Clinical stability: absence of haemodynamic, respiratory or metabolic failure requiring specific management that contraindicates a medical transfer to the imaging centre.
You likely can't join if
- For all participants: Pregnant or breastfeeding woman
- For control group participants: Women not wishing to maintain effective contraception during the 30-day study period.
- For all participants: Contraindication to MRI
- For all participants: Known allergic reaction to PET radiotracer or its excipient
- For all participants: History of pathology responsible for a disturbance of the dopaminergic system
- For all participants: Current treatment with a dopaminergic agonist or antagonist effect
See the full eligibility criteria
- For all participants: Female or male between 18 and 65 years of age
- For all participants: Affiliation with a social security scheme or beneficiary of such a scheme.
- For all participants: Informed consent signed by the participant or by the trusted person (for patients)
- For all patients: Patient admitted to hospital, victim of non-penetrating TBI occurring within <30 days: traumatic coma (GCS < 10 with M < 6) on hospital admission.
- For all patients: Discontinuation of sedative treatments for more than 48 hours
- For all patients: Clinical stability: absence of haemodynamic, respiratory or metabolic failure requiring specific management that contraindicates a medical transfer to the imaging centre.
- For the TC-COMA group: Severe TBI, corresponding to prolonged abolition of consciousness - coma- and defined by an initial Glasgow Coma Scale, GCS < 8 with a motor score, M < 6), without return to consciousness (GCS < 10 with M < 6) on the day of inclusion.
- For the severe TC-ROS group: severe TBI, corresponding to prolonged abolition of consciousness - coma - and defined by an initial Glasgow Coma Scale, GCS < 8 with a motor score, M < 6), with return to consciousness clinically identified by evidence of responses to simple commands (GCS > or = 10 with M = 6).
- For control subjects: age (+ or - 2 years) and sex matched to patients in the TC-COMA group
- For all participants: Pregnant or breastfeeding woman
- For control group participants: Women not wishing to maintain effective contraception during the 30-day study period.
- For all participants: Contraindication to MRI
- For all participants: Known allergic reaction to PET radiotracer or its excipient
- For all participants: History of pathology responsible for a disturbance of the dopaminergic system
- For all participants: Current treatment with a dopaminergic agonist or antagonist effect
- For all participants: Persons under court protection, guardianship or curatorship
- For all patients: Coma of origin other than TBI
- For all patients: Decompressive craniectomy with anatomical changes incompatible with standardized image analysis (midline deviation > 2 cm).
- For control group participants: Female of childbearing age without effective contraception
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.