Exploring dopamine disruptions in traumatic coma using advanced imaging techniques

Dopaminergic Disruption Induced by Traumatic Coma: Multimodal Neuroimaging Approaches to Characterize Dopaminergic Pathways Using 18F-LBT-999 PET

This study is trying to see if using a special brain scan can help understand how dopamine changes in people with traumatic coma after a serious brain injury and if those changes relate to their recovery of consciousness.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Government)
• Locations: 1 site (Toulouse)
• Trial ID: NCT06930261 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who have experienced a non-penetrating traumatic brain injury resulting in a Glasgow Coma Scale score of less than 10.

Not a fit: Patients with penetrating traumatic brain injuries or those who do not meet the specified Glasgow Coma Scale criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients recovering from traumatic brain injuries.

How similar studies have performed: While there is existing research on dopamine's role in consciousness recovery, this specific approach using 18F-LBT-999 PET imaging is relatively novel and underexplored.

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.

Where this trial is running

Toulouse

• CHU de Toulouse — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: BENJAMINE SARTON, MD, PhD

Conditions Coma, Traumatic; moderate traumatic brain injury; severe traumatic brain injury