Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-24 @ 12:54 PM
NCT ID:
NCT06930261
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06930261
Study Brief:
Protocol Section:
NCT06930261