Dopaminergic disruption induced by traumatic coma: multimodal neuroimaging approaches to characterize dopaminergic pathways abnormalities and biomarkers of recovery using the [18F]LBT-999 radiotracer.

Phase 1

• Conditions: Comatose Traumatic Brain Injury patients; MedDRA version: 20.1Level: LLTClassification code: 10060690Term: Traumatic brain injury Class: 10022117; Therapeutic area: Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: CTIS2023-504893-39-00
• Lead Sponsor: Institut National De La Sante Et De La Recherche Medicale

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified