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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA)
Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants
Intensive cognitive training of a letter memory updating task, 9 sessions
University Medicine Greifswald
Greifswald, Germany
Working memory performance at post-assessment
Percent change of correct responses in the n-back task compared to the pre-training assessment.
Time frame: 3 weeks
Working memory performance at follow-up assessment
Percent change of correct responses in the n-back task compared to the pre-training assessment.
Time frame: 4 weeks after training
Working memory training performance (Letter Updating Task) at post-assessment
Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task.
Time frame: 3 weeks
Working memory training performance (Letter Updating Task) at follow-up assessment
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.
Time frame: 4 weeks after training
Quality of Life at post-assessment
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.
Time frame: 3 weeks
Quality of Life at follow-up assessment
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.
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Standardized instructed PMR training, 9 sessions
Time frame: 4 weeks after training
Visuo-spatial performance at post-assessment
Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.
Time frame: 3 weeks
Visuo-spatial performance at follow-up assessment
Visuo-spatial performance at follow-up assessment operationalized by number of correctly recalled items in the VR task.
Time frame: 4 weeks after training
Post COVID-19 Function at post-assessment
Scores of Post COVID-19 Functional Scale (PCFS). PCFS scale grad from 0 (no functional limitations) to 4 (severe functional limitations).
Time frame: 3 weeks
Post COVID-19 Function at follow-up assessment
Scores of Post COVID-19 Functional Scale (PCFS). PCFS scale grad from 0 (no functional limitations) to 4 (severe functional limitations).
Time frame: 4 weeks after training