Brain Network Disruptions Related to Traumatic Coma (Coma3D)

Toulouse University Hospital

Status: Completed

Conditions: Traumatic Coma

Treatments: Radiation: PET examination with radiopharmaceutical drug [18F] DPA-714; Diagnostic Test: MRI examination; Biological: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03482115

RC31/16/8257

2017-001986-26 (EudraCT Number)

Details and patient eligibility

About

To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging approaches encompassing several up-to-date techniques as structural MRI, fMRI and positron emission tomography (PET) scan (neuroinflammation ligands).

Full description

So far, the gold standard for neuroprognostication of severe traumatic brain injury (TBI) or anoxic encephalopathy is the bedside behavioural evaluation. Nevertheless, the predictive value of such an exclusive clinical approach has been consistently reported as limited and insufficient in this challenging clinical setting. Recent theoretical and experimental data converge towards the idea of the critical implication of long-range brain connection in consciousness access and maintain. Nevertheless, previous studies have focused on the specific analysis of some targeted connections (regions of interest), and have used exclusively a single approach in neuroimaging (structural or functional imaging), with no interest in the neuro-inflammatory and neurodegenerative mechanisms likely associated with these disconnection phenomena. So, cerebral disconnection characterization at the level of the whole brain, at different stages of pathological abolition of consciousness must be made, on an anatomical, functional and metabolic scale. This descriptive study represents a first step in the identification of relevant multimodal imaging biomarkers. This will then lead to a larger study to identify the prognostic impact of these different biomarkers obtained in the acute phase of patient management.

Enrollment: 59 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for patients:

• Male or female / age between 18 to 75 years.
• Coma of traumatic or anoxic aetiology (GCS < 10).
• Early (< 1 month after TBI) and after the complete withdrawal of sedative agents.
• Written agreement for participation (legal responsible).

Inclusion criteria for controls:

• Male or female / age between 18 to 75 years, paired with patients (gender and age).
• Written agreement for participation

Exclusion criteria:

• Patients without public insurance regime.
• Pregnancy.
• Specific contraindication to the use of MRI (metallic material) or PET (specific allergy related to the ligand).

Exclusion criteria for controls:

• pharmacological treatments which could interfere with consciousness (left to the judgement of the investigator)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Comatose patient

Experimental group

Description:

Subject with coma of traumatic or anoxic aetiology : PET examination with radiopharmaceutical drug \[18F\] DPA-714, MRI examination and Blood samples.

Treatment:

Biological: Blood samples

Diagnostic Test: MRI examination

Radiation: PET examination with radiopharmaceutical drug [18F] DPA-714

control volunteers

Other group

Description:

subject control : PET examination with radiopharmaceutical drug \[18F\] DPA-714, MRI examination and Blood samples.

Treatment:

Biological: Blood samples

Diagnostic Test: MRI examination

Radiation: PET examination with radiopharmaceutical drug [18F] DPA-714