Viewing Study NCT06391970



Ignite Creation Date: 2024-05-06 @ 8:27 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06391970
Status: RECRUITING
Last Update Posted: 2024-04-30
First Post: 2024-04-29

Brief Title: Digital Cognition Study During Long-COVID
Sponsor: Luxembourg Institute of Health
Organization: Luxembourg Institute of Health

Study Overview

Official Title: Exploring Long-COVID Impact on Cognition Through Digital Neuropsychological Assessment
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DIGICOG
Brief Summary: 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 tastesmell 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

1 to test and validate a very novel device which uses the eyes movement during tasks to evaluate very quickly the cognitive functioning
2 to study potential cognitive problems long-term after COVID-19 and
3 to explore how cognition could be preserved

Finally this project will also help to bring the innovative device tested to the market for accurately monitoring people with long COVID
Detailed Description: 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 httpswwwlihlublogour-news-1posta-year-of-predi-covid-407blog_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 VIEWMINDs technology in a spin-off project to additionally screen neurocognitive conditions after COVID-19 improving Long COVID diagnosis The state-of-the-art VIEWMINDs 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 httpswwwviewmindaicopy-of-terms-of-service httpsww2frostcomnewspress-releasesviewmind-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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
20220805 OTHER National Research Ethics Committee CNER Luxembourg None
16758430 OTHER_GRANT None None