serology testing profiles description
BiologicalSARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)
Other names: biomarkers
NCT Number: NCT04785157
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.
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Notify Me18 year and older
All sexes
Observational
University Hospital of Toulouse, Toulouse, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)
Other names: biomarkers
systemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF)
in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia)
structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity)
multi-domains neurocognitive assessment
Time frame: Day 0
Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination
Time frame: Month 3
Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination
Time frame: Day 0
SARS-CoV-2 quasispecies detection in blood specimen
Time frame: Month 3
SARS-CoV-2 quasispecies detection in blood specimen
Time frame: Day 0
SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen
Time frame: Month 3
SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen
Time frame: Day 0
Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)
Time frame: month 3
Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)
University Hospital, Toulouse
Other
SARS-CoV-2 Neurotropism, micRoglial ActivatioN and Cytokine dySregulaTiOn in COVID-19 Patients With Delirium
Acronym: BRAINSTORM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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