Main focus: U09. 9 Post-COVID syndrome with the above complaints (one characteristic is sufficient) U09.9 G93.3 R53 F06.8
Conditions
Interventions
Group 1: Patients with fatigue-associated post-COVID symptoms complete 16 trials of the ‘mobile immersive Virtual Memory Task’ (mimVMT), as well as a neuropsychological test battery (Fatigue Severity
Sponsors
Tagesklinik für kognitive Neurologie, Universitätsklinikum Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Post-COVID group: 1. Confirmed COVID-19 diagnosis: Positive test confirmed by PCR or rapid test 2. Post-COVID-Symptoms: • Duration: Symptoms that persist for at least three months after infection (relevant is the COVID infection that triggered the complained symptoms. 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 have occurred in temporal relation to COVID infection and persist for more than three months. These lead to inability to work or a significant reduction in daily activities • Additional considerations: Documentation of any identified COVID infections or vaccinations is required, although these do not serve as exclusion criteria. Participants with multiple infections are admitted. • Healthy controls may also have suffered COVID infection (given the widespread prevalence, it is almost impossible to find people who have not yet had contact with the SARS-COV-2 virus) and/or be vaccinated. Infections and vaccinations are also collected here. The people are asked in detail about possible long-term symptoms in temporal connection with their infection. Only those who have not noticed any change in their cognitive performance or mental or physical resilience in connection with their COVID infection are admitted as healthy controls. 3. Characteristics of the participants: • Resilience assessment: People with fatigue symptoms in particular need sufficient resilience to be included in the study. Participants must demonstrate sufficient resilience in a preliminary telephone interview and complete a self-assessment regarding their ability to participate in the study program (duration approx. 2 hours per appointment plus travel time). • BDI-II-Score: Beck Depression Inventory II score of 28 or lower • Drug stability: Participants must be in stable drug treatment; taking antidepressants is acceptable 4. General criteria: • Age: Persons aged 18 to 65 years • Sufficient German language skills and comprehension • Comprehension skills: Sufficient understanding of study procedures, consent forms, and ability to participate in self-reported results • Vision skills: Sufficient eyesight to work on study materials, assessments, and cognitive tests (2) Healthy control subjects: The same general inclusion criteria apply as for the study population of the post-COVID groups (see above).
Exclusion criteria
Exclusion criteria: (1) Post-COVID group: 1. Medical Pre-History: • Chronic fatigue and cognitive deficits before PCS: history of fatigue due to ME/CFS or MCI prior to COVID-19 infection • Pre-existing incapacity for work: Receipt of a reduced earning capacity pension before the onset of COVID-19 symptoms 2. Additional diseases and symptoms: • Neurological and psychiatric symptoms: Acute neurological symptoms or severe psychiatric illness not associated with PC • Pre-existing neurological disorders: other neurological disorders that existed before COVID-19 or occurred after COVID infection (e.g., strokes, epilepsy, etc.). • Severe PC symptoms: hospitalization or intensive care due to COVID-19 3. Characteristics of the participants: • Depression: BDI II score greater than 28 • Current medication: Use of certain medications that are expected to have an influence on the study results, especially neuroleptics, antiepileptics or morphine 4. General criteria: • Substance Abuse: A History of Alcohol or Drug Abuse • Breastfeeding women, women in pregnancy or planned pregnancy • Post-vac syndrome: symptoms attributed to post-vaccination syndrome after immunization • Persons who are unable to give consent (e.g. in the case of dementia) • Lack of consent to the notification of chance finds • Significant restriction of the visual field that impairs everyday vision (e.g. glaucoma, macular degeneration) (2) Healthy control subjects The same general exclusion criteria apply as for the study population of the post-COVID groups (see above).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Change in heart rate variability and heart rate over 5 time points before, during and after a cognitive task (task in virtual reality (VR)) in comparison between the groups Aim of the study: Differentiation between different post-COVID subtypes based on the results of the neuropsychological testing and the vegetative data measured with wearables (heart rate variability (HRV), heart rate (HR)). | — |
Secondary
| Measure | Time frame |
|---|---|
| (2) Difference in heart rate variability and heart rate between the three study groups at test time 1 (baseline) (3) Impact of anxiety and depression (assessed using the Hospital Anxiety and Depression Scale - German version (HADS-D)) on HRV and HR (4) Exploratory data analysis on the impact of other neuropsychological test results on HRV and HR, as well as their change over the measurement time points - Symptoms of cardiovascular autonomic dysfunction, adapted from the Composite Autonomic Symptom Score-31 (COMPASS-31) - Fatigue Severity Scale (FSS) - Subjective Cognitive Decline Interview (SCD-I) - adapted - Neuropsychological Assessment Battery (NAB) - screening module, subtests executive functions, memory, attention - Mean Distance Error (MDE) as an indicator of memory performance in the VR memory task (‘mobile immersive virtual memory task mimVMT’ (modified after Belger et al. 2023)) | — |
Countries
Germany
Contacts
Public ContactMia Neubauer
Max-Planck-Insitut für Kognitions- und Neurowissenschaften
Outcome results
None listed