Clinical trial NCT04726176: COVID-19 and the Brain
Official title: COVID-19 and Brain Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Brain
Neurocognition
fMRI
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
First posted: 2021-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both the "ICU COVID-19" and "Mild COVID-19" groups will be selected from COVID-19 patients that were admitted to the UZ Brussel hospital.

The "Healthy volunteers" group will be selected through the network of the involved researchers (convenience sampling).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Brain scans
timeFrame: Up to 12 weeks
measure: Neurocognitive test battery
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Emotion regulation task
timeFrame: Up to 12 weeks
measure: Mental fatigue Visual Analogue Scale (M-VAS)
timeFrame: Up to 12 weeks
measure: Physical fatigue Visual Analogue Scale (P-VAS)
timeFrame: Up to 12 weeks
measure: Return to work questionnaire
timeFrame: Up to 12 weeks
measure: Profile of Mood States (POMS)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Kevin De Pauw, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.