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Completed

NCT Number: NCT04726176

COVID-19 and the Brain

The main objective of this project is:

1. To assess the impact of COVID-19 on the brain and executive functioning.

Twenty adult subjects of UZ Brussels (volunteers), who needed intensive care due to COVID-19 (n=10) or exhibited mild symptoms due to COVID-19 (n=10), will be recruited after hospital discharge. After signing an informed consent the subjects will undergo brain scans (T1, DTI, SWI, DWI, FLAIR MRI and rsfMRI), an emotion regulation task and a neurocognitive test battery. The latter test battery will be performed using an iPad and will test different neurocognitive functions such as memory, abstract thinking, spatial orientation and attention. The duration of the test battery is 18min. The total duration of one trial is estimated at one hour and a half. All tests are planned at the department of Radiology-Magnetic Resonance (UZ Brussel). After three months patients will visit the department of Radiology-Magnetic Resonance a second time for the same experimental trial. Additionally, a matched control group (n = 20; non covid or ICU patients) will be included and undergo the same tests in order to compare the results of the brain scans, emotional regulation task and neurocognitive test battery with results of both Covid-groups. Next to objective data, questionnaires will be filled out, i.e. visual analogue scales of mental and physical fatigue, Profile of Mood States and some additional return to work questions.

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Key information

Conditions

Covid19 Brain COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neurocognition Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases fMRI

Age range

35 year–76 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vrije Universiteit Brussel

Brussels, 1050, Belgium

Who can participate

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

Inclusion criteria

  • Adult patients of UZ Brussels, who left the hospital and needed intensive care
  • Adult patients of UZ Brussels, who left the hospital and exhibited mild symptoms
  • Healthy volunteers (who never had COVID-19)
  • Ability to give informed consent
  • Dutch or French speaking

Exclusion criteria

  • History of neurological diseases

Treatment and study plan

Exposure to COVID-19

Biological

To study the exposure of COVID-19 on the brain and executive functioning

Primary outcomes

  1. Brain scans

    Time frame: Up to 12 weeks

    T1, FLAIR MRI, SWI, DWI, DTI, rsfMRI and a task-based functional MRI

  2. Neurocognitive test battery

    Time frame: Up to 12 weeks

    The computerized cognitive test battery "Cognition" will be conducted using an iPad. This cognitive test battery is sensitive to multiple domains at high-level cognitive performance. It consists of the motor praxis test (measure of sensorimotor speed), visual object learning test (measure of spatial learning and memory), abstract matching (measure of abstraction), line orientation test (measure of spatial orientation), digit symbol substitution test (measure of complex scanning and visual tracking), balloon analogue risk test (measure of risk decision making), NBACK (measure of working memory) and psychomotor vigilance test (measure, or vigilant attention) and takes approximately 18 min in total.

Secondary outcomes

  1. Emotion regulation task

    Time frame: Up to 12 weeks

    During the last brain scan, i.e. the task-based functional fMRI, a short emotion regulation task will be employed. Twenty negatively rated stimuli from the International Affective Picture System balanced on arousal (exciting/calm) will be randomly allocated to one of two blocks, one block per condition (experiential awareness, i.e. switching attention towards the bodily felt affective experience / cognitive reappraisal i.e. cognitively changing how one appraises the situation represented on the negative pictures).

  2. Mental fatigue Visual Analogue Scale (M-VAS)

    Time frame: Up to 12 weeks

    Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)

  3. Physical fatigue Visual Analogue Scale (P-VAS)

    Time frame: Up to 12 weeks

    Subjective measure of physical fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)

  4. Return to work questionnaire

    Time frame: Up to 12 weeks

    Questionnaire encompassing the following questions:

    • When did you restart work duties after hospital discharge?
    • Did you consider yourself fit to return to work?
    • What is your general experience of restart working?
    • Have you been equally as productive, less productive, or more productive than before the COVID-19 infection/since the former consultation?

  5. Profile of Mood States (POMS)

    Time frame: Up to 12 weeks

    The Profile of Mood States (POMS) is a 65 item self-report psychological instrument. The POMS measures six different dimensions of mood states over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. These 65 items are rated on a five-point scale ranging from "not at all" to "extremely".

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • Universitair Ziekenhuis Brussel

Registry information

Official study title

COVID-19 and Brain Health

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2021
Registry last updated
Apr 29, 2022

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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