Image

Cognitive Impairment and Fatigue After Mild to Moderate COVID-19

Cognitive Impairment and Fatigue After Mild to Moderate COVID-19

Recruiting
18-65 years
All
Phase N/A

Powered by AI

Overview

The primary aim of the project is to map fatigue, cognitive and visual dysfunctions and possible underlying pathophysiological mechanisms in persons with long-term symptoms after a mild to moderate COVID-19 infection. Secondary goals are to study whether covarying factors such as depression and sleep disorders contribute to the results.

Description

The primary aim of the project is to map neuropsychological and visual dysfunctions and possible underlying pathophysiological mechanisms in patients suffering from Post-COVID condition (PCC) after a mild to moderate COVID-19 infection. Secondary goals are to study whether covarying factors such as depression and sleep disorders contribute to the results.

The main objectives are:

  1. Which cognitive problems (self-reported and test results/performance based?) are typical in patients with post-COVID syndrome compared to non-symptomatic controls?
  2. Which pre-existing factors affect cognitive functions and fatigue after a mild to moderate COVID-19 infection?
  3. Is there a relationship between self-perceived symptoms, cognitive and visual test results, optical coherence tomography (OCT) examination, imaging results, and biomarkers in patients who have undergone mild COVID-19 infection and does this differ compared to non-symptomatic controls?
  4. How are fatigue, cognitive fatigability and vision-related disorders related to neuronal correlates and changes in the retina examined with OCT and biomarkers (astocyte-derived extracellular vesicles (High Mobility Group Box 1 (Hmbg1) and S100B) and inflammatory markers) in patients who have remaining symptoms after a mild COVID-19 infection and do the results differ from what can be seen in non-symptomatic controls?
  5. Are specific cognitive dysfunctions and fatigue/cognitive fatigability correlated with astocyte-derived extracellular vesicles in patients who have remaining symptoms after a mild COVID-19 infection?
  6. How do symptoms evolve over one and two years?

STUDY DESIGN The study is a controlled longitudinal cohort study that includes cross-sectional sub-studies of imaging and biomarkers.

STUDY SETTING Outpatient rehabilitation clinic at the Department of Rehabilitation Medicine at Danderyd University Hospital and Karolinska University Hospital, both located in Stockholm, Sweden. At the Cognitive post-COVID clinic at Danderyd University Hospital, patients with long-term cognitive problems and fatigue are investigated after a mild to moderat (not ICU treated) COVID-19 infection. Clinical assessments are included for all participants but in a sub-study we will consecutively invite participants to also investigate vision and eye functions, brain connectivity and, biomarkers.

PARTICIPANTS PATIENTS All patients present at the Cognitive Post-COVID clinic att the Department of Rehabilitation Medicine at Danderyd University Hospital will have a medical examination. Those patients with cognitive dysfunctions related to a COVID-19 infection will be offered a comprehensive neuropsychological investigation and asked if they are interested in participating in the cohort study.

The first 100 patients are consecutively asked if they also are interested in taking biomarkers. Of these, up to 30 patients, meeting the inclusion criteria for functional Magnetic Resonance Imaging (fMRI) are asked for participation in the a sub-study including an fMRI investigation as well as an optometric and OCT investigation.

NON-SYMPTOMATIC CONTROLS 50 healthy controls who do not suffer from long term symptoms after a COVID-19 infection >3 months from the latest infections or have not had a COVID-19 infection will be investigated for comparison. The same exclusion criteria as for the patients are applied also for the controls. The non-symptomatic controls will undergo neuropsychological examination, examination of visual functions, sampling of biomarkers, as well as fMRI examination and an OCT examination. The controls will be matched with the patients regarding age, gender and length of education.

The patients will be followed-up with questionnaires regarding current symptoms after 1 and 2 years after the neuropsychological investigation.

Eligibility

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).

Study details
    Post COVID-19 Condition
    Cognitive Impairment
    Fatigue
    Mental

NCT06042530

Danderyd Hospital

25 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.