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Completed

NCT Number: NCT04785157

Neurotropism and Neuroinflammation in COVID-19 Patients With Delirium.

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (male or female > or = 18 years)
  • COVID-19 (positive respiratory track PCR test < 30 days)
  • Delirium (CAM-ICU criteria)
  • informed and written consent to participate in the study by patient's surrogate.

Exclusion criteria

  • medical decision of withdrawal of life sustaining treatments previous to patients recruitment
  • former neurological or psychiatric disability
  • MRI or PET scan contraindication
  • pregnancy
  • hemodynamic or respiratory failure precluding patient's transport / MRI or PET scanning

Treatment and study plan

serology testing profiles description

Biological

SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)

Other names: biomarkers

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

Primary outcomes

  1. PET imaging examination

    Time frame: Day 0

    Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination

  2. PET imaging examination

    Time frame: Month 3

    Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination

Secondary outcomes

  1. SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen

    Time frame: Day 0

    SARS-CoV-2 quasispecies detection in blood specimen

  2. SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen

    Time frame: Month 3

    SARS-CoV-2 quasispecies detection in blood specimen

  3. SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen

    Time frame: Day 0

    SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen

  4. SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen

    Time frame: Month 3

    SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen

  5. multimodal MRI in acute delirium phase

    Time frame: Day 0

    Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)

  6. multimodal MRI 3 months after the acute delirium phase

    Time frame: month 3

    Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

SARS-CoV-2 Neurotropism, micRoglial ActivatioN and Cytokine dySregulaTiOn in COVID-19 Patients With Delirium

Acronym: BRAINSTORM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Aug 24, 2023

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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