Digital Cognition Study During Long-COVID

NCT06391970 | Recruiting

• 3 other identifiers: 2021061316758430202208/05
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19, Long Haul

Keywords

Cognition, Digital Biomarkers, Validation, Cognitive Reserve

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

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.

Device: Cognitive screening

Interventions

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.

DigiCog Intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• ViewMind: collaborator

Study Sites (1)

Luxembourg Institute of Health, LCTR

Luxembourg, L-1210, Luxembourg

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Magali PERQUIN, PhD

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali PERQUIN, PhD

CONTACT

(+352) 26970; magali.perquin@lih.lu

Manon GANTENBEIN, PhD

CONTACT

manon.gantenbein@lih.lu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: April 30, 2024
• Study Start: April 15, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 30, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

LU (1)