Exploring dopamine disruptions in traumatic coma using advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the role of dopaminergic pathways in patients experiencing traumatic coma due to moderate to severe traumatic brain injury. By utilizing the novel radiotracer 18F-LBT-999 in PET imaging, the research aims to identify early-phase disruptions in dopamine systems that may correlate with consciousness recovery. Participants will include adults aged 18-65 who have been hospitalized for a traumatic brain injury within the last 30 days and exhibit specific criteria related to their level of consciousness. The study seeks to enhance understanding of the neurochemical basis of consciousness and recovery in acute coma.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Toulouse
  Toulouse, France Recruiting

Study contacts

• Study coordinator: BENJAMINE SARTON, MD, PhD
• Email: benjamine.sarton@inserm.fr
• Phone: +33672346866

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.