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Completed

NCT Number: NCT04944147

Cognitive Training and Brain Stimulation in Patients With Post-COVID-19 Cognitive Impairment

The aim of the study is to investigate effects of brain stimulation-assisted cognitive training in patients with persistent subjective or objective cognitive impairment after polymerase chain reaction (PCR)-positive COVID-19 disease.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine Greifswald

Greifswald, Germany

About this study

Long-term persistent symptoms occur in a substantial number of patients diagnosed with coronavirus 2019 disease (COVID-19). First evidence suggests that long-term symptoms develop not only after severe courses of the disease, but also after less serious illness and include various symptoms such as fatigue and impaired memory, concentration or sleep. During recovery, these symptoms present a heavy burden for patients, who then often experience psychological distress and reduced quality of life. The goal of the present study is to assess the effects of cognitive training alone or in combination with tDCS on cognitive performance, quality of life and mental health in patients with subjective or objective cognitive impairments following post-COVID disease. Patients will either participate in a three-week cognitive training with concurrent online high-definition tDCS application or placebo ("sham") tDCS or participate in an evidence-based muscle relaxation training combined with placebo tDCS. We hypothesize that cognitive training with sham or active tDCS will result in more pronounced improvement on a transfer task compared to the control group. We also hypothesize that training combined with anodal tDCS will lead to significantly higher performance on a transfer task than training combined with sham tDCS. Additionally, we will determine effects on specifically trained and other untrained cognitive functions immediately after the intervention as well as their maintenance one month later.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of COVID-19 condition at least 4-6 weeks prior to study inclusion
  • Self-reported concerns regarding cognitive functioning.
  • Age: 18-60 years.

Exclusion criteria

  • Acute COVID-19 illness.
  • History of dementia before COVID-19.
  • Other neurodegenerative neurological disorders; epilepsy or history of seizures.
  • Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician.
  • History of severe alcoholism or use of drugs.
  • Severe psychiatric disorders such as severe depression (if not in remission) or psychosis.
  • Contraindication to tDCS application (Antal et al. 2017).

Treatment and study plan

Anodal tDCS

Device

Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA)

Sham tDCS

Device

Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants

Intensive cognitive training

Behavioral

Intensive cognitive training of a letter memory updating task, 9 sessions

Progressive Muscle Relaxation (PMR)

Behavioral

Standardized instructed PMR training, 9 sessions

Primary outcomes

  1. Working memory performance at post-assessment

    Time frame: 3 weeks

    Percent change of correct responses in the n-back task compared to the pre-training assessment.

Secondary outcomes

  1. Working memory performance at follow-up assessment

    Time frame: 4 weeks after training

    Percent change of correct responses in the n-back task compared to the pre-training assessment.

  2. Working memory training performance (Letter Updating Task) at post-assessment

    Time frame: 3 weeks

    Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task.

  3. Working memory training performance (Letter Updating Task) at follow-up assessment

    Time frame: 4 weeks after training

    Performance in primary memory training task (Letter Updating Task) at follow-up assessment, operationalized by number of correctly recalled lists in the letter updating task.

  4. Quality of Life at post-assessment

    Time frame: 3 weeks

    PROMIS (Patient-Reported Outcome Measures and Health-Related Quality of Life) score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function). Every item is rated on scale from 1 to 5, the higher the score the worse the self-reported health evaluation.

  5. Quality of Life at follow-up assessment

    Time frame: 4 weeks after training

    PROMIS (Patient-Reported Outcome Measures and Health-Related Quality of Life) score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function). Every item is rated on scale from 1 to 5, the higher the score the worse the self-reported health evaluation.

  6. Visuo-spatial performance at post-assessment

    Time frame: 3 weeks

    Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.

  7. Visuo-spatial performance at follow-up assessment

    Time frame: 4 weeks after training

    Visuo-spatial performance at follow-up assessment operationalized by number of correctly recalled items in the VR task.

  8. Post COVID-19 Function at post-assessment

    Time frame: 3 weeks

    Scores of Post COVID-19 Functional Scale (PCFS). PCFS scale grad from 0 (no functional limitations) to 4 (severe functional limitations).

  9. Post COVID-19 Function at follow-up assessment

    Time frame: 4 weeks after training

    Scores of Post COVID-19 Functional Scale (PCFS). PCFS scale grad from 0 (no functional limitations) to 4 (severe functional limitations).

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-COVID-19 Cognitive Impairment

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2021
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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