COVID-19 and the Brain

NCT04726176 | Completed

• 1 other identifier: 1432020000338
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Brain; Neurocognition; fMRI

Outcome Measures

Primary Outcomes (2)

• Brain scans

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

  Up to 12 weeks

• 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 Outcomes (5)

• Emotion regulation task

  Up to 12 weeks

• Mental fatigue Visual Analogue Scale (M-VAS)

  Up to 12 weeks

• Physical fatigue Visual Analogue Scale (P-VAS)

  Up to 12 weeks

• Return to work questionnaire

  Up to 12 weeks

• Profile of Mood States (POMS)

  Up to 12 weeks

Study Arms (2)

COVID-19

Participants who were admitted to the intensive care unit due to COVID-19 or participants who exhibited "mild" symptoms due to COVID-19 but needed to be hospitalized.

Biological: Exposure to COVID-19

Healthy control group

Healthy matched participants who never had COVID-19.

Interventions

Exposure to COVID-19 BIOLOGICAL

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

COVID-19

Eligibility Criteria

• Age: 35 Years - 76 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• History of neurological diseases

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

Location

Related 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.

  PMID: 32882182 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kevin De Pauw, Prof. Dr.

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 27, 2021
• Study Start: January 30, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)