U09.9
Conditions
Interventions
Group 1: Individuals with post-COVID syndrome (PCS) undergo telephone screening. Subsequently, they are invited for testing at the laboratory on two consecutive days. During the laboratory testing, pa
attention, memory, and executive functions) (Petermann et al., 2016)
- Questionnaires: Fatigue Severity Scale (FSS
Krupp et al., 1989), Hospital Anxiety and Depression Scale – German Version (HADS-D
Herrmann-Lingen et al., 2018), the adapted Subjective Cognitive Complaints Interview (SCC-I
Miebach et al., 2019), Multimodal Assessment of Interoceptive Awareness, Version 2, German Translation (MAIA-2, subscales “not-worrying” and “trusting”
Mehling et al., 2018), as well as the UCLA Loneliness Scale, 3-item version (UCLA-LS-3
Hughes et al., 2004)
- Physiological measurements: (a) 48-hour recordings using a smartwatch, chest strap, and accelerometer to measure heart rate, heart rate variability, physical activity levels, a
(b) assessment of heart rate and heart rate variability during the VR task
Sponsors
Universitätsklinikum Leipzig Medizinische Fakultät / Tagesklinik für kognitive Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Post-COVID group: Confirmed COVID-19 diagnosis: Positive test result, confirmed by PCR or rapid test 1. Post-COVID symptoms: • Duration: Symptoms that persist for at least three months after the infection (the COVID-19 infection that triggered the reported symptoms is relevant. If, for example, this was the second infection, the date of the second infection applies). • Primary symptoms: Moderate to severe fatigue or cognitive symptoms that occurred in temporal association with a COVID infection and persist for more than three months. These lead to an inability to work or a significant reduction in daily activities • Additional information: Documentation of all identified COVID-19 infections or vaccinations is required, although these do not serve as exclusion criteria. Participants with multiple infections are eligible. • Healthy control subjects may also have had a COVID infection (given the widespread prevalence, it is virtually impossible to find people who have not yet been exposed to the SARS-CoV-2 virus) and/or be vaccinated. Infections and vaccinations are also recorded here. Participants are asked in detail about possible long-term symptoms that may be related to their infection. Only those who have not experienced any changes in their cognitive performance or mental or physical resilience related to their COVID infection are eligible as healthy control subjects. 2. Participant Characteristics: • Resilience assessment: Individuals must demonstrate sufficient resilience to be eligible for study inclusion. This should be assessed particularly carefully in individuals with fatigue. To this end, participants must demonstrate sufficient resilience during a preliminary interview and complete a self-assessment of their ability to participate in the study program (duration: approximately 2 hours per session, plus travel time) • Depression: Only participants without a depressive disorder before the onset of PCS complaints are eligible for participation • stable medication: Participants must be on stable medication; the use of antidepressants is acceptable 3. General Criteria • Age: Individuals between the ages of 18 and 65 • Sufficient German language skills and comprehension • Capacity to give informed consent and understand the study: Sufficient understanding of study procedures and consent forms, and the ability to participate in self-reported assessments • Visual acuity: Sufficient vision to work with study materials, VR task, assessments, and cognitive tests (2) Healthy Control Participants: The same general inclusion criteria apply as for the study population of the post-COVID groups (see above). • No persistent cognitive, mental, or physical symptoms that are temporally associated with a SARS-CoV-2 infection.
Exclusion criteria
Exclusion criteria: Post-COVID Groups: 1. Medical History: • Chronic fatigue and cognitive deficits prior to PCS: History of fatigue due to ME/CFS or MCI prior to COVID-19 infection • Pre-existing inability to work: Receipt of disability benefits prior to the onset of COVID-19 symptoms 2. Additional Disorders and Symptoms: • Neurological and psychiatric symptoms: Acute neurological symptoms or severe psychiatric disorders not associated with COVID-19 • Pre-existing neurological disorders: Other neurological conditions that existed before COVID-19 or developed after COVID-19 infection (e.g., strokes, epilepsy, etc.). • Severe COVID-19 symptoms: Hospitalization or intensive care due to COVID-19 3. Participant Characteristics: • Depression: Participants with a depressive disorder diagnosed before the onset of the PCS-complaints are excluded • Current medication: Use of certain medications that are expected to influence the study results, particularly antipsychotics, antiepileptics, or morphine 4. General Criteria: • Substance abuse: A history of alcohol or drug abuse • Post-vaccination syndrome: Symptoms attributed to a post-vaccination syndrome following immunization • Significant narrowing of the visual field that impairs everyday vision (e.g., glaucoma, macular degeneration) • Individuals unable to give informed consent (e.g., due to dementia) • Breastfeeding women, pregnant women, or women planning to become pregnant • Lack of consent to be informed about incidental findings (2) Healthy Control Participants The same general exclusion criteria as for the post-COVID study population apply (see above).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Identification of multimodal functional profiles within the post-COVID cohort. To this end, features derived from VR-based behavior (specifically mean distance errors, task completion time, placement time, and performance trajectories over time), neuropsychological testing, questionnaire-based self-reports, and physiological recordings of heart rate, heart rate variability, activity, and sleep will be jointly analyzed. (2) Investigation of the relation between subjective symptoms and objective measurements (3) Identification of the combinations of characteristics that allow for a valid and reliable objective differentiation between individuals with and without post-COVID syndrome. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Prediction of functional limitations in work, social participation, and resilience relevant to daily life (2) Feasibility and acceptability of the mimVMT and the multimodal assessment in PCS | — |
Countries
Germany
Contacts
Public ContactJulia Belger
Universitätsklinikum Leipzig Medizinische Fakultät / Tagesklinik für kognitive Neurologie
Outcome results
None listed