Covid19NCT04726176
COVID-19 and the Brain
An observational study of Covid19 and Brain, run by Vrije Universiteit Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 35 to 76 years
- Conditions the study is for
- Covid19, Brain, Neurocognition
- What is being tested?
- Exposure to COVID-19
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jan 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 76 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- History of neurological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 and Brain Health
The main objective of this project is:
- 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
- Being tested
- Exposure to COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to COVID-19Biological
To study the exposure of COVID-19 on the brain and executive functioning
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Exposure to COVID-19 | |
| Healthy control group | Healthy matched participants who never had COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain scans
T1, FLAIR MRI, SWI, DWI, DTI, rsfMRI and a task-based functional MRI
Measured: 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.
Measured: Up to 12 weeks
Secondary outcomes (5)
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).
Measured: Up to 12 weeks
Mental fatigue Visual Analogue Scale (M-VAS)
Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
Measured: Up to 12 weeks
Physical fatigue Visual Analogue Scale (P-VAS)
Subjective measure of physical fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
Measured: Up to 12 weeks
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?
Measured: Up to 12 weeks
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".
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start30 Jan 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Principal investigator, Kevin De Pauw, Vrije Universiteit Brussel
- Investigators
- Kevin De Pauw, Prof. Dr., Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726176
- Sponsor's protocol ID
- 1432020000338
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers, K De Pauw, R Meeusen, B Tassignon, J De Mey, L Van Liedekerke, H Raeymaekers, F De Ridder, G Nagels, J Van Schependom, M Vandekerckhove, L Van Imschoot, P Lacor, L Seyler, R Mertens, S Allard, AM Van Binst, LCB Fuentes, N Hoornaert, M Naeyaert, A Radwan, P Van Schuerbeek, S Sunaert and E De Waele will have access to IPD. All electronic data is stored on the shared encrypted university drive. All files \& written data will be stored in a locked filing cabinet. With only the previously mentioned researchers having access. All data will be anonymized by assigning an exclusive identity code to each participant. The identity of the individual will only be known by the previously stated research team. Anonymized data will be stored for up to four years to allow for publication access, further analyses and auditing. All personal data, including health questionnaires and signed consent forms, will be destroyed within 12 months of study completion.
Publications
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.
PubMed 32882182
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Brain Health
- ClinicalTrials.gov ID
- NCT04726176
- Acronym / sponsor ID
- 1432020000338
- Conditions
- Covid19, Brain, Neurocognition, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this project is:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Biological: Exposure to COVID-19Participants 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. |
| Healthy control group | – | –Healthy matched participants who never had COVID-19. |
Who may qualify
- Ages
- 35 to 76 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- History of neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to COVID-19To study the exposure of COVID-19 on the brain and executive functioning | Biological | COVID-19 |
Primary outcome
Brain scans
Time frame: Up to 12 weeks
T1, FLAIR MRI, SWI, DWI, DTI, rsfMRI and a task-based functional MRI
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.
5 secondary outcomes
Emotion regulation task
Time frame: Up to 12 weeks
Mental fatigue Visual Analogue Scale (M-VAS)
Time frame: Up to 12 weeks
Physical fatigue Visual Analogue Scale (P-VAS)
Time frame: Up to 12 weeks
Return to work questionnaire
Time frame: Up to 12 weeks
Profile of Mood States (POMS)
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Background: PubMed 32882182Iadecola 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.
- Individual participant dataSharing planned: No. Researchers, K De Pauw, R Meeusen, B Tassignon, J De Mey, L Van Liedekerke, H Raeymaekers, F De Ridder, G Nagels, J Van Schependom, M Vandekerckhove, L Van Imschoot, P Lacor, L Seyler, R Mertens, S Allard, AM Van Binst, LCB Fuentes, N Hoornaert, M Naeyaert, A Radwan, P Van Schuerbeek, S Sunaert and E De Waele will have access to IPD. All electronic data is stored on the shared encrypted university drive. All files \& written data will be stored in a locked filing cabinet. With only the previously mentioned researchers having access. All data will be anonymized by assigning an exclusive identity code to each participant. The identity of the individual will only be known by the previously stated research team. Anonymized data will be stored for up to four years to allow for publication access, further analyses and auditing. All personal data, including health questionnaires and signed consent forms, will be destroyed within 12 months of study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin De Pauw, Prof. Dr. principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Brain, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain scans (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.