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| ID | Type | Description | Link |
|---|---|---|---|
| 16758430 | Other Grant/Funding Number | Fonds National de la Recherche (FNR) Luxembourg | |
| 202208/05 | Other Identifier | National Research Ethics Committee (CNER) Luxembourg |
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| Name | Class |
|---|---|
| ViewMind | INDUSTRY |
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The persistence of the COVID-19 disease symptoms, such as extreme fatigue, shortness of breath, cardiovascular complications, depression and anxiety, pain, brain fog, loss of taste/smell, headaches as well as loss of memory has been evoked in many studies. This project aims at approaching the persistent symptomatology on cognition, more than 1 year after the infection.
When we refer to cognition, we refer to everything associated with knowledge, that is, the accumulation of information we have acquired through learning or from our experience. We can define cognitive processes as the processes we use to incorporate new knowledge and make decisions based on it. Through these processes several cognitive functions intervene: perception, attention, memory, reasoning, language, learning, decision-making. All of these cognitive functions work together to integrate knowledge as a whole and create an interpretation of the world around us. Usually neuropsychological tests are used to evaluate cognitive problems, they consist in different exercises sometimes with words, figures to draw, images to remember, movement to repeat, numbers to link together etc.
The DigiCog project here propose
Finally, this project will also help to bring the innovative device tested to the market, for accurately monitoring people with long COVID.
The Digital Cognition study ("DigiCog") will be conducted within the framework of an already existing robust research project, Predi-COVID (NCT04380987), launched in May 2020 by the Luxembourg Institute of Health (LIH). This cohort study has originally enrolled -and is still ongoing- patients with COVID-19 disease and followed them for over a year in order to approach the potential long-term health effects of the pathology, the "chronic post-COVID syndrome", (https://www.lih.lu/blog/our-news-1/post/a-year-of-predi-covid-407#blog\_content) or more frequently referred to as "Long COVID" . If the Predi-COVID study has first been devoted to acute and early symptomatology, it now covers a wide range of medical conditions potentially linked to the persistence of COVID-19 disease, such as extreme fatigue, pain, allergy, renal and cardiovascular complications, stress and anxiety, emotions, memory impairment as well as neurological complications. In this context, the working collaboration between LIH and VIEWMIND Company is a major opportunity to incorporate VIEWMIND's technology in a spin-off project, to additionally screen neurocognitive conditions after COVID-19, improving Long COVID diagnosis. The state-of-the-art VIEWMIND's technology (herein referred to as "VMTech") is indeed a non-invasive and reliable digital tool, using artificial intelligence to deliver accurate results especially on cognitive performance, areas of the brain functioning and high-level motor skills, as well as identifying neurocognitive pathologies (see https://www.viewmind.ai/copy-of-terms-of-service; https://ww2.frost.com/news/press-releases/viewmind-applauded-by-frost-sullivan-for-its-one-of-a-kind-digital-biomarker-technology-for-neurocognitive-disorders). Moreover this cognitive screening will be analyzed according to persistent COVID-19 symptomatology, but also in relationship with the initial severity of SARS-COV-2 infection, and individual features and habits of participants. As a multifactorial approach, the project will test VMTech in a research framework on COVID-19, it will additionally use a complementary cognitive battery of tests as the gold standard.
Hence, this collaborative project fits with the expectations and requirements of the funding joint call Healthtech, addressing the need of gathering evidence of effectiveness "in real-life" of the developed tool. The DigiCog project consortium is adequate to validate the digital biomarker technology, being a balanced public private partnership, based on an on-going powerful cohort study, a long lasting expertise in public and precision health, and an advanced and recognized technology. The project will help to bring VMTech to the market for accurately monitoring people with Long COVID.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DigiCog Intervention | Other | Although DigiCog participants receive two interventions (the new digital device and the gold standard method), they are not randomized to different intervention groups. Instead, each participant serves as their own control, receiving both interventions sequentially. Therefore, the study has one arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive screening | Device | The cognitive abilities of participants will be assessed using two different interventions: the first utilizing the new digital device, and the second employing the gold standard method. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive status assessed with the digital device, of individuals with/without symptoms persisting long-term after COVID-19 disease. | Each assessment and evaluation session lasts approximately 20 minutes and occurs once. | |
| Cognitive status assessed with the gold standard procedure, of individuals with/without symptoms persisting long-term after COVID-19 disease. | Each assessment and evaluation session lasts approximately 1 h and occurs once. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magali PERQUIN, PhD | Contact | (+352) 26970 | 744 | magali.perquin@lih.lu |
| Manon GANTENBEIN, PhD | Contact | manon.gantenbein@lih.lu |
| Name | Affiliation | Role |
|---|---|---|
| Magali PERQUIN, PhD | Luxembourg Institute of Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luxembourg Institute of Health, LCTR | Recruiting | Luxembourg | L-1210 | Luxembourg |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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DigiCog is a crossover interventional study, involving participants selected both with and without the specific condition of long COVID. The intervention in this study is the use of a new digital device, which is being evaluated in comparison to the gold standard method.
Each participant receives both interventions in a predetermined sequence. This crossover design enables within-subject comparisons, as each participant acts as their own control. By comparing outcomes within the same participant under different interventions, this design helps to reduce variability and increase the statistical power of the study.
NB: Although a crossover design may typically imply multiple arms, in this specific study, participants serve as their own controls, resulting in only one arm.
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| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |