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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005827-35 | EudraCT Number |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Emerging evidence indicates that SARS-CoV-2, the etiologic agent of COVID-19, can cause neurological, neuropsychological and psychiatric complications. Given the global dimensions of the current pandemic, there is to consider the possible large-scale neurocognitive impact of COVID-19. Therefore, there is an urgent need for longitudinal studies to determine the acute and chronic effects that COVID-19 may have on the Central Nervous System. These putative effects include the possibility that the CNS serves as a reservoir for the virus, and that COVID-19 triggers CNS deleterious inflammatory cascades and neurodegenerative process. The public implications of these effects are very important in the long term.
The BRAINSTORM project aims at creating a proof-of-concept dataset from severe COVID-19 patients with delirium. For the first time, this longitudinal study will rely on repeated and concomitant: i) SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF), ii) systemic and central immune response characterization, associated to the assessment of CNS damage biomarkers (peripheral blood and CSF), iii) in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia), iv) structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity), v) multi-domains neurocognitive assessment. This dataset will be made FAIR to allow open data use and to prepare future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| severe COVID-19 patients with delirium | i) SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF) ii) systemic and central immune response characterization, associated to the assessment of CNS damage biomarkers (peripheral blood and CSF) iii) in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia) iv) structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity) v) multi-domains neurocognitive assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serology testing profiles description | Biological | SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF) |
| Measure | Description | Time Frame |
|---|---|---|
| PET imaging examination | Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination | Day 0 |
| PET imaging examination | Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen | SARS-CoV-2 quasispecies detection in blood specimen | Day 0 |
| SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen |
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Inclusion Criteria:
Exclusion Criteria:
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patients from hospital
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| Name | Affiliation | Role |
|---|---|---|
| Stein SILVA, MD, PhD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Toulouse | Toulouse | France | ||||
| CHRU Tours |
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TSPO (Translocator protein) phenotype SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF) systemic and central immune response characterization (peripheral blood and cerebrospinal fluid CSF)
|
| immune response characterization | Biological | systemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF) |
|
| in vivo brain PET-TSPO acquisitions | Other | in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia) |
|
| brain MRI assessment | Other | structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity) |
|
| neurocognitive assessment | Behavioral | multi-domains neurocognitive assessment |
|
SARS-CoV-2 quasispecies detection in blood specimen
| Month 3 |
| SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen | SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen | Day 0 |
| SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen | SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen | Month 3 |
| multimodal MRI in acute delirium phase | Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI) | Day 0 |
| multimodal MRI 3 months after the acute delirium phase | Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI) | month 3 |
| Tours |
| France |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D003693 | Delirium |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D015415 | Biomarkers |
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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