BRAINSTORM: Neurotropism and Neuroinflammation in COVID-19 Patients With Delirium.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Biological: serology testing profiles description
SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)
Other Names:
Biological: immune response characterization
systemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF)
Other: in vivo brain PET-TSPO acquisitions
in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia)
Other: brain MRI assessment
structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity)
Behavioral: neurocognitive assessment
multi-domains neurocognitive assessment
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Outcome Measures
Primary Outcome Measures
- PET imaging examination [Day 0]
Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination
- PET imaging examination [Month 3]
Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination
Secondary Outcome Measures
- SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen [Day 0]
SARS-CoV-2 quasispecies detection in blood specimen
- SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen [Month 3]
SARS-CoV-2 quasispecies detection in blood specimen
- SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen [Day 0]
SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen
- SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen [Month 3]
SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen
- multimodal MRI in acute delirium phase [Day 0]
Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)
- multimodal MRI 3 months after the acute delirium phase [month 3]
Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients (male or female > or = 18 years)
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COVID-19 (positive respiratory track PCR test < 30 days)
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Delirium (CAM-ICU criteria)
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informed and written consent to participate in the study by patient's surrogate.
Exclusion Criteria:
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medical decision of withdrawal of life sustaining treatments previous to patients recruitment
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former neurological or psychiatric disability
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MRI or PET scan contraindication
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pregnancy
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hemodynamic or respiratory failure precluding patient's transport / MRI or PET scanning
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Toulouse | Toulouse | France | ||
| 2 | CHRU Tours | Tours | France |
Sponsors and Collaborators
- University Hospital, Toulouse
- Institut National de la Santé Et de la Recherche Médicale, France
Investigators
- Principal Investigator: Stein SILVA, MD, PhD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/20/0441
- 2020-005827-35