COVID-19, Long HaulDIGICOGNCT06391970
Digital Cognition Study During Long-COVID
A study testing Cognitive screening in people with COVID-19, Long Haul, run by Luxembourg Institute of Health at 1 site in Luxembourg.
Trial 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 taste/smell, headaches as well as loss of memory has been evoked in many studies. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Long Haul
- What is being tested?
- Cognitive screening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteLuxembourg
- Study dates
- 15 Apr 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Manon GANTENBEIN, PhD contact
Luxembourg1 site, 1 recruiting
- Recruiting
Luxembourg Institute of Health, LCTR
Luxembourg, L-1210
Magali PERQUIN, PhD, +352 26970 ext. 744, magali.perquin@lih.lu
Manon GANTENBEIN, PhD, manon.gantenbein@lih.lu
About this study
Official title: 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.
Read more
The DigiCog project here propose
- to test and validate a very novel device, which uses the eyes movement during tasks to evaluate very quickly the cognitive functioning;
- to study potential cognitive problems long-term after COVID-19; and
- 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.
Read the 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.
- Conditions
- COVID-19, Long Haul
- Being tested
- Cognitive screening
- Keywords
- Cognition, Digital Biomarkers, Validation, Cognitive Reserve
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive screeningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cognitive screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive status assessed with the digital device, of individuals with/without symptoms persisting long-term after COVID-19 disease.
Measured: 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.
Measured: Each assessment and evaluation session lasts approximately 1 h and occurs once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start15 Apr 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19, Long HaulStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- ViewMind
- Responsible party
- Principal investigator, Magali Perquin, Luxembourg Institute of Health
- Investigators
- Magali PERQUIN, PhD, Principal investigator, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391970
- Sponsor's protocol ID
- 20210613
- Other IDs
- 16758430, 202208/05
- Acronym
- DIGICOG
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Long-COVID Impact on Cognition Through Digital Neuropsychological Assessment
- ClinicalTrials.gov ID
- NCT06391970
- Acronym / sponsor ID
- DIGICOG / 20210613
- Conditions
- COVID-19, Long Haul
- Keywords
- Cognition, Digital Biomarkers, Validation, Cognitive Reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- ViewMind
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- to test and validate a very novel device, which uses the eyes movement during tasks to evaluate very quickly the cognitive functioning;
- to study potential cognitive problems long-term after COVID-19; and
- 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", (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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| DigiCog Intervention | Other | Device: Cognitive screeningAlthough 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive screeningThe 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. | Device | DigiCog Intervention |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manon GANTENBEIN, PhD contact
Magali PERQUIN, PhD principal investigator
Luxembourg Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive screening in people with COVID-19, Long Haul, run by Luxembourg Institute of Health at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magali PERQUIN, PhD ((+352) 26970 ext. 744, magali.perquin@lih.lu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.