Mapping cognitive impairment and fatigue after mild to moderate COVID-19

Cognitive Impairment and Fatigue After Mild to Moderate COVID-19 - Relation to Biomarkers and Neuronal Network Functions

This study is trying to see if people who had mild to moderate COVID-19 and are still feeling tired or having trouble thinking can be helped by understanding their symptoms and comparing them to those who didn't have long-term issues.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Danderyd Hospital (other)
• Locations: 1 site (Stockholm)
• Trial ID: NCT06042530 on ClinicalTrials.gov

What this trial studies

This project aims to investigate cognitive and visual dysfunctions in individuals experiencing long-term symptoms following a mild to moderate COVID-19 infection. It will assess neuropsychological performance and explore potential underlying mechanisms, including the role of depression and sleep disorders. The study will compare cognitive problems in affected individuals to non-symptomatic controls and examine relationships between self-reported symptoms, cognitive test results, and biomarkers. Various assessments, including neuropsychological evaluations, optometric investigations, and imaging techniques, will be utilized.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 and older who have experienced persistent cognitive impairment or fatigue for more than three months following a verified mild to moderate COVID-19 infection.

Not a fit: Patients with severe mental illnesses, neurodegenerative diseases, or significant visual impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cognitive and fatigue-related issues in post-COVID patients, leading to better management strategies.

How similar studies have performed: While studies on post-COVID conditions are emerging, this specific approach focusing on cognitive and visual dysfunctions is relatively novel.

Eligibility criteria

Inclusion Criteria:

• Persons 18 years and older with a history of (\> 3 months) verified COVID-19 (PCR / rapid test / antibody) or an infection that is most likely a SARS-CoV-2 infection (e.g., a close relative had a verified infection that coincided in time with the patient's illness) and who have persistent problems with cognitive impairment or fatigue affecting the return to previous activities / employment.

Exclusion Criteria:

* Dominant recurrent and / or fluctuating symptoms of infection, circulatory, respiratory or cardiac problems.
* Co-morbidities that may cause cognitive impairment such as neurodegenerative disease, substance abuse, severe mental illness (eg. schizophrenia, mano depressive disorder) or severe depression.
* Not fluent in Swedish, as test and self-reports rely on good mastering of the Swedish language.
* Severe premorbid visual impairment.

Additionally for the fMRI study:

* Not verified SARS-CoV-2 infection with a Polymerase Chain Reaction (PCR) / rapid test / antibody review
* Traumatic brain injury
* Neuropsychiatric disease such as diagnosed ADHD or autism
* Younger than 25 years or older than 55 years (to avoid the risk that the brain is not fully developed or that there is a risk of age-related changes in the brain).
* MRI contraindications (such as metal objects in the body, fear of cramped spaces, pregnancy, body weight over 130 kg), and left-handedness (to increase the likelihood of uniform topological lateralization in the cohort).

Where this trial is running

Stockholm

• Department of Rehabilitation Medicine, Danderyd Hospital — Stockholm, Sweden (RECRUITING)

Study contacts

• Principal investigator: Marika C Möller, PhD — Department of Rehabilitation Medicine, Danderyd University Hospital
• Study coordinator: Marika C Möller, PhD

Conditions: Post COVID-19 Condition, Cognitive Impairment, Fatigue, Mental, cognition, fatigue, COVID-19, neuropsychology, biomarkers