Brain Network Disruptions Related to Traumatic Coma

Not Applicable

Completed

• Conditions: Traumatic Coma
• Interventions: Radiation: PET examination with radiopharmaceutical drug [18F] DPA-714; Diagnostic Test: MRI examination; Biological: Blood samples

• Registration Number: NCT03482115
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2018-02-08
• Study Start: 2018-03-07
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-03-29
• Primary Completion: 2021-11-07
• Study Completion: 2022-02-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control volunteers	PET examination with radiopharmaceutical drug [18F] DPA-714	subject control : PET examination with radiopharmaceutical drug \[18F\] DPA-714, MRI examination and Blood samples.
Comatose patient	MRI examination	Subject with coma of traumatic or anoxic aetiology : PET examination with radiopharmaceutical drug \[18F\] DPA-714, MRI examination and Blood samples.
Comatose patient	PET examination with radiopharmaceutical drug [18F] DPA-714	Subject with coma of traumatic or anoxic aetiology : PET examination with radiopharmaceutical drug \[18F\] DPA-714, MRI examination and Blood samples.
control volunteers	Blood samples	subject control : PET examination with radiopharmaceutical drug \[18F\] DPA-714, MRI examination and Blood samples.
control volunteers	MRI examination	subject control : PET examination with radiopharmaceutical drug \[18F\] DPA-714, MRI examination and Blood samples.
Comatose patient	Blood samples	Subject with coma of traumatic or anoxic aetiology : PET examination with radiopharmaceutical drug \[18F\] DPA-714, MRI examination and Blood samples.

Primary Outcome Measures

Name	Time	Method
Matrix of the neuroimaging data in PET examination	First Visit, within three days after day 0	neuroinflammation by \[18F\] DPA-714 during PET imaging

Secondary Outcome Measures

Name	Time	Method
Glasgow Coma Scale (GCS)	Inclusion	The Glasgow Coma Scale is divided into three components : ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points).; Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language).; It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness.
Coma Recovery Scale Revised (CRS-R)	3 months +/- 3 days after the primary brain insult	The Coma Recovery Scale Revised is divided into three components : return to consciousness (RECUP), vegetative neurological state (ENV) or minimal state of consciousness (ECM).; This scale has been validated in French, with a value of Cronbach's Alpha estimated at 0.8.; It is a score whose values are between 100 (normal level of consciousness) and 10 (coma). ENV and ECM have intermediate values (approximately 30 and 60, respectively).
FOUR score	3 months +/- 3 days after the primary brain insult	The FOUR score is a scale of 4 items and 16 points concerning qualitative behavioural assessment
analysis of imaging parameters obtained in MRI	First Visit, within three days after day 0	assessing the strength of connectivity between different regions for the whole brain, measurement of anatomical connectivity, measurement of cortical thickness. All this measure use voxel/volume unit of the brain

Trial Locations

Locations (1)

Hospital; 🇫🇷 Toulouse, France