COVID-19 and the Brain

Covid19 Clinical Trial

Official title:

COVID-19 and Brain Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726176
• Other study ID #: 1432020000338
• Status: Completed
• Start date: January 30, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2022
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 35 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain
• COVID-19
• Covid19
• fMRI
• Neurocognition

Intervention

Biological:
• Exposure to COVID-19
To study the exposure of COVID-19 on the brain and executive functioning

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Iadecola C, Anrather J, Kamel H. Effects of COVID-19 on the Nervous System. Cell. 2020 Oct 1;183(1):16-27.e1. doi: 10.1016/j.cell.2020.08.028. Epub 2020 Aug 19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain scans	T1, FLAIR MRI, SWI, DWI, DTI, rsfMRI and a task-based functional MRI	Up to 12 weeks
Primary	Neurocognitive test battery	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.	Up to 12 weeks
Secondary	Emotion regulation task	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).	Up to 12 weeks
Secondary	Mental fatigue Visual Analogue Scale (M-VAS)	Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)	Up to 12 weeks
Secondary	Physical fatigue Visual Analogue Scale (P-VAS)	Subjective measure of physical fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)	Up to 12 weeks
Secondary	Return to work questionnaire	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?	Up to 12 weeks
Secondary	Profile of Mood States (POMS)	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".	Up to 12 weeks