Cognitive Profiling and Validation of a Digital Cognitive Assessment Tool in Post-COVID-19 Condition: Protocol for a Single-Center, Cross-Sectional Study (DigiCog Study)
Lacomba-Arnau, E.; Da Rocha Oliveira, R.; Monteiro, S.; Pauly, C.; Vaillant, M.; Celebic, A.; Bulaev, D.; Fischer, A.; Fagherazzi, G.; Fernandez, G.; Shulz, M.; Perquin, M.
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BackgroundCognitive impairment is among the most frequently reported and disabling persistent symptoms following SARS-CoV-2 infection. Despite growing evidence of its prevalence, the characterization of domain-specific cognitive profiles and the identification of modifiable factors influencing cognitive outcomes in post-COVID-19 condition (PCC) remains scarce. Digital cognitive assessment tools have emerged as scalable and examiner-independent alternatives to traditional neuropsychological testing, but their validation in post-infectious contexts is still limited. ObjectiveThe DigiCog study aims to characterize cognitive profiles associated with PCC, to evaluate a novel digital cognitive assessment technology (ViewMind, VMTech) against standardized neuropsychological measures, and to explore the potential role of cognitive reserve (CR) proxies in shaping cognitive outcomes following SARS-CoV-2 infection. MethodsDigiCog is a single-center cross-sectional study conducted within the Luxembourgish Predi-COVID cohort (NCT04380987). Participants aged 25-65 years, with and without persistent COVID-19 symptoms, are invited to participate. Cognitive assessments are performed during face-to-face sessions by trained nurses and neuropsychologists using both the VMTech device and standardized neuropsychological tests. Additional data on PCC symptom status, CR, sociodemographic characteristics, fatigue, and psychological factors are also collected. Agreement between digital and standard cognitive assessments will be evaluated using Cohens kappa coefficient, with sensitivity, specificity, and receiver operating characteristic analyses as secondary measures. Cognitive performance will be compared between participants with and without PCC, and associations with CR proxies will be explored. ResultsParticipant recruitment began in May 2023. As of March 2025, 199 participants had been enrolled. Data collection has been completed. Data processing and statistical analyses are ongoing. ConclusionsThe DigiCog study will provide new insights into cognitive functioning in PCC and evaluate the validity of a novel digital cognitive assessment approach. By integrating neuropsychological testing, digital assessment, and cognitive reserve, the study may inform scalable and more personalized approaches to cognitive screening and monitoring in post-infectious conditions. Study registrationClinicalTrials.gov NCT06391970; Luxembourg National Research Ethics Committee approval No. 202208/05.
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