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Digital Cognition Study During Long-COVID

NCT ID: NCT06391970

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2025-09-30

Brief Summary

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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

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

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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.

Conditions

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COVID-19, Long Haul

Keywords

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Cognition, Digital Biomarkers, Validation, Cognitive Reserve

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Cognitive screening

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ViewMind

INDUSTRY

Sponsor Role collaborator

Luxembourg Institute of Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Magali Perquin

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magali PERQUIN, PhD

Role: PRINCIPAL_INVESTIGATOR

Luxembourg Institute of Health

Locations

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Luxembourg Institute of Health, LCTR

Luxembourg, , Luxembourg

Site Status RECRUITING

Countries

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Luxembourg

Central Contacts

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Magali PERQUIN, PhD

Role: CONTACT

Phone: (+352) 26970

Email: [email protected]

Manon GANTENBEIN, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Magali PERQUIN, PhD

Role: primary

Manon GANTENBEIN, PhD

Role: backup

Other Identifiers

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16758430

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202208/05

Identifier Type: OTHER

Identifier Source: secondary_id

20210613

Identifier Type: -

Identifier Source: org_study_id