Clinical trial NCT03482115: Brain Network Disruptions Related to Traumatic Coma
Official title: Whole Brain Connectivity Changes Induced by Traumatic Coma: Combined Structural, Functional and Neuroinflammatory Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Coma
Keywords: coma
traumatic brain injury
anoxic encephalopathy
brain connectome
neuroinflammation
prognosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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)

Primary outcomes:
measure: Matrix of the neuroimaging data in PET examination
timeFrame: First Visit, within three days after day 0
Secondary outcomes:
measure: Glasgow Coma Scale (GCS)
timeFrame: Inclusion
measure: Coma Recovery Scale Revised (CRS-R)
timeFrame: 3 months +/- 3 days after the primary brain insult
measure: FOUR score
timeFrame: 3 months +/- 3 days after the primary brain insult
measure: analysis of imaging parameters obtained in MRI
timeFrame: First Visit, within three days after day 0
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Stein SILVA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sarton B, Tauber C, Fridman E, Peran P, Riu B, Vinour H, David A, Geeraerts T, Bounes F, Minville V, Delmas C, Salabert AS, Albucher JF, Bataille B, Olivot JM, Cariou A, Naccache L, Payoux P, Schiff N, Silva S. Neuroimmune activation is associated with neurological outcome in anoxic and traumatic coma. Brain. 2024 Apr 4;147(4):1321-1330. doi: 10.1093/brain/awae045.
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