Brain Network Disruptions Related to Traumatic Coma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2022-02-07

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Traumatic Coma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Comatose patient

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

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

Using a Biograph 6 Truepoint device. Establishment of a venous route. It will be injected 4 MBq / kg of 18F-DPA714 by the venous route with a maximum dose of 280 MBq. The patient will be placed along the orbito-meatal line. Brain acquisition will begin 60 minutes post-injection

MRI examination

Intervention Type DIAGNOSTIC_TEST

MRI device Philips Achieva - 3Tesla. The acquisition of the data will include different sequences (anatomical MRI, diffusion MRI, resting fMRI) and will last a total of one hour (installation and removal of the patient in the machine included).anatomical MRI associated with FLAIR (Fluid Attenuation Inversion Recovery) and diffusion tensor (tractography).

Blood samples

Intervention Type BIOLOGICAL

Characterization of the TSPO phenotype (mitochondrial translocase) for tracer affinity

control volunteers

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

Group Type OTHER

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

Intervention Type RADIATION

Using a Biograph 6 Truepoint device. Establishment of a venous route. It will be injected 4 MBq / kg of 18F-DPA714 by the venous route with a maximum dose of 280 MBq. The patient will be placed along the orbito-meatal line. Brain acquisition will begin 60 minutes post-injection

MRI examination

Intervention Type DIAGNOSTIC_TEST

MRI device Philips Achieva - 3Tesla. The acquisition of the data will include different sequences (anatomical MRI, diffusion MRI, resting fMRI) and will last a total of one hour (installation and removal of the patient in the machine included).anatomical MRI associated with FLAIR (Fluid Attenuation Inversion Recovery) and diffusion tensor (tractography).

Blood samples

Intervention Type BIOLOGICAL

Characterization of the TSPO phenotype (mitochondrial translocase) for tracer affinity

Interventions

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

Using a Biograph 6 Truepoint device. Establishment of a venous route. It will be injected 4 MBq / kg of 18F-DPA714 by the venous route with a maximum dose of 280 MBq. The patient will be placed along the orbito-meatal line. Brain acquisition will begin 60 minutes post-injection

Intervention Type RADIATION

MRI examination

MRI device Philips Achieva - 3Tesla. The acquisition of the data will include different sequences (anatomical MRI, diffusion MRI, resting fMRI) and will last a total of one hour (installation and removal of the patient in the machine included).anatomical MRI associated with FLAIR (Fluid Attenuation Inversion Recovery) and diffusion tensor (tractography).

Intervention Type DIAGNOSTIC_TEST

Blood samples

Characterization of the TSPO phenotype (mitochondrial translocase) for tracer affinity

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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).

* 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).

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes