Digital Cognition Study During Long-COVID (DIGICOG)

April 29, 2024 updated by: Magali Perquin, Luxembourg Institute of Health

Exploring Long-COVID Impact on Cognition Through Digital Neuropsychological Assessment

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

  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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", (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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants who have previously participated in the Predi-COVID study (Registration number NCT04380987), or who have experienced COVID-19 at least once before 2022.
  • Participants who have signed the informed consent form
  • Participants aged between 25 and 65 years old

Exclusion Criteria:

  • Psychological or neurological disorders history especially those detected before the COVID-19 disease (e.g. epilepsy, stroke, chronic fatigue) as well as treatment that could interfere with the assessment (e.g., antipsychotics, antidepressants, mood stabilizers, antiepileptics, benzodiazepines)
  • Poor eyesight, rendering the use of the digital device impossible
  • Inability to speak the proposed languages

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: DigiCog Intervention
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.
Device: Cognitive screening
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive status assessed with the digital device, of individuals with/without symptoms persisting long-term after COVID-19 disease.
Time Frame: Each assessment and evaluation session lasts approximately 20 minutes and occurs once.
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.
Time Frame: Each assessment and evaluation session lasts approximately 1 h and occurs once.
Each assessment and evaluation session lasts approximately 1 h and occurs once.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luxembourg Institute of Health

Collaborators

ViewMind

Investigators

  • Principal Investigator: Magali PERQUIN, PhD, Luxembourg Institute of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210613
  • 16758430 (Other Grant/Funding Number: Fonds National de la Recherche (FNR) Luxembourg)
  • 202208/05 (Other Identifier: National Research Ethics Committee (CNER) Luxembourg)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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