COVID-19 and the Brain

NCT ID: NCT04726176

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-30

Study Completion Date

2021-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19 Brain Neurocognition fMRI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Exposure to COVID-19

Intervention Type BIOLOGICAL

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

Healthy control group

Healthy matched participants who never had COVID-19.

No interventions assigned to this group

Interventions

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Exposure to COVID-19

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role lead

Responsible Party

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Kevin De Pauw

Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin De Pauw, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

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Vrije Universiteit Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 32882182 (View on PubMed)

Other Identifiers

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1432020000338

Identifier Type: -

Identifier Source: org_study_id

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