Neurological and Neuropsychological Sequelae of COVID-19 Infection
NCT04745611, Completed, Maastricht University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Neurological and Neuropsychological Sequelae of COVID-19 Infection | ClinicalTrials.gov |
| NCT number | NCT04745611 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 329 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Maastricht University | ClinicalTrials.gov |
| Conditions | COVID-19 Infection | ClinicalTrials.gov |
| Interventions | MRI, Neuropsychological assessment, Questionnaires Patient, Questionnaires Family | ClinicalTrials.gov |
| First posted | 2021-02-09 | ClinicalTrials.gov |
| Last updated | 2022-05-02 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in participation | 1) 6-9 months and 2) 12-15 months after hospital discharge | Life participation (social, occupational, mobility) measured by the Utrecht Scale for Evaluation of Rehabilitation-Participation - Restrictions subscale (USER-P-R). The subscale consists of 11 items. Each item score ranges from 0 (not possible at all) to 3 (no difficulty at all), resulting in a total minimum score of 0 and a total maximum score of 33 points, with a higher score indicating less participation restrictions. | ClinicalTrials.gov |
| Primary | Change in patient quality of life | 1) 6-9 months and 2) 12-15 months after hospital discharge | Quality of life measured by the EuroQol-5D-5L (EQ-5D-5L). The EQ-5D-5L consists of 5 items with 5 levels. The minimum total score is 5 and the maximum total score is 25, with higher scores indicating more problems. | ClinicalTrials.gov |
| Primary | Presence of MRI abnormalities | 6-9 months after hospital discharge | Presence or absence of MRI abnormalities assessed with a 3T cranial MRI scan | ClinicalTrials.gov |
| Primary | Neurological symptoms | 6-9 months after hospital discharge | Measures with the neurological and neuropsychological sequelae of COVID-19 questionnaire (NeNeSCo-Q), a questionnaire that has been created for the purpose of this study to assess the most common neurological symptoms (e.g., reduced sense of taste and/or smell, headaches, neuropathic pain) experienced by patients infected with COVID-19. The questionnaire consists of 9 items being rated with present (yes = 1) and not present (no = 0), resulting in a minimum total score of 0 and a maximum total score of 9. | ClinicalTrials.gov |
| Primary | Deficits in cognition | 6-9 months after hospital discharge | Deficits in general cognition are measured with the Montreal Cognitive Assessment (MoCA). | ClinicalTrials.gov |
| Primary | Deficits in memory | 6-9 months after hospital discharge | Measured with the Rey's auditory verbal learning test (RAVLT) | ClinicalTrials.gov |
| Primary | Deficits in visual attention & task switching | 6-9 months after hospital discharge | Measured with Trail Making Test A/B (TMT) | ClinicalTrials.gov |
| Primary | Deficits in selective attention, cognitive flexibility & processing speed | 6-9 months after hospital discharge | Measured with Stroop Test | ClinicalTrials.gov |
| Primary | Deficits in working memory, attention & executive function | 6-9 months after hospital discharge | Measured with Digit Span Coding | ClinicalTrials.gov |
| Primary | Change in subjective cognitive complaints | 1) 6-9 months and 2) 12-15 months after hospital discharge | Assessed with the Checklist for post-IC cognitive complaints (CLC-IC) | ClinicalTrials.gov |
| Primary | Change in depression/anxiety | 1) 6-9 months and 2) 12-15 months after hospital discharge | Measured with the Hospital anxiety and depression scale | ClinicalTrials.gov |
| Primary | Change in post-traumatic stress symptoms | 1) 6-9 months and 2) 12-15 months after hospital discharge | Measured with the Primary Care Post-Traumatic Stress Disorder (PC-PTSD-5) questionnaire | ClinicalTrials.gov |
| Primary | Change in family burden | 1) 6-9 months and 2) 12-15 months after hospital discharge | Measured with the Caregiver Strain Index (CSI) | ClinicalTrials.gov |
| Primary | Change in family quality of life | 1) 6-9 months and 2) 12-15 months after hospital discharge | Measured by the EQ-5D-5L. The EQ-5D-5L consists of 5 items with 5 levels. The minimum total score is 5 and the maximum total score is 25, with higher scores indicating more problems. | ClinicalTrials.gov |
| Secondary | MRI abnormalities (specific) | 6-9 months after hospital discharge | MRI abnormalities such as cerebral micro-infarctions / bleedings, and white matter hyperintensities. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 19
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 21946660 | BACKGROUND | PubMed |
| 24088092 | BACKGROUND | PubMed |
| 25305070 | BACKGROUND | PubMed |
| 29243344 | BACKGROUND | PubMed |
| 29940026 | BACKGROUND | PubMed |
| 30711227 | BACKGROUND | PubMed |
| 30736830 | BACKGROUND | PubMed |
| 32109013 | BACKGROUND | PubMed |
| 32294339 | BACKGROUND | PubMed |
| 32329044 | BACKGROUND | PubMed |
| 32384020 | BACKGROUND | PubMed |
| 32436101 | BACKGROUND | PubMed |
| 32544034 | BACKGROUND | PubMed |
| 32593341 | BACKGROUND | PubMed |
| 32682993 | BACKGROUND | PubMed |
| 32883670 | BACKGROUND | PubMed |
| 32901580 | BACKGROUND | PubMed |
| 34620676 | DERIVED | PubMed |
| 40088612 | DERIVED | PubMed |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.