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

Not Applicable

Completed

• Conditions: COVID-19; Post-COVID-19
• Interventions: Device: Sham tDCS; Device: Anodal tDCS; Behavioral: Intensive cognitive training; Behavioral: Progressive muscle relaxation (PMR)

• Registration Number: NCT04944147
• Lead Sponsor: University Medicine Greifswald

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-06-29
• Study Start: 2022-01-05
• Primary Completion: 2024-09-09
• Study Completion: 2024-10-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anodal tDCS + cognitive training	Intensive cognitive training	device: anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA) over left dorsolateral prefrontal cortex behavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions
Sham tDCS + Progressive Muscle Relaxation training	Sham tDCS	device: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex behavioral: progressive muscle relaxation (PMR) standardized instructed PMR (20 minutes), 9 sessions
Anodal tDCS + cognitive training	Anodal tDCS	device: anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA) over left dorsolateral prefrontal cortex behavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions
Sham tDCS + cognitive training	Intensive cognitive training	device: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex behavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions
Sham tDCS + cognitive training	Sham tDCS	device: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex behavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions
Sham tDCS + Progressive Muscle Relaxation training	Progressive muscle relaxation (PMR)	device: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex behavioral: progressive muscle relaxation (PMR) standardized instructed PMR (20 minutes), 9 sessions

Primary Outcome Measures

Name	Time	Method
Working memory performance at post-assessment	3 weeks	Percent change of correct responses in the n-back task compared to the pre-training assessment.

Secondary Outcome Measures

Name	Time	Method
Post COVID-19 Function at follow-up assessment	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).
Visuo-spatial performance at post-assessment	3 weeks	Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.
Working memory performance at follow-up assessment	4 weeks after training	Percent change of correct responses in the n-back task compared to the pre-training assessment.
Working memory training performance (Letter Updating Task) at post-assessment	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.
Quality of Life at post-assessment	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.
Visuo-spatial performance at follow-up assessment	4 weeks after training	Visuo-spatial performance at follow-up assessment operationalized by number of correctly recalled items in the VR task.
Post COVID-19 Function at post-assessment	3 weeks	Scores of Post COVID-19 Functional Scale (PCFS). PCFS scale grad from 0 (no functional limitations) to 4 (severe functional limitations).
Working memory training performance (Letter Updating Task) at follow-up assessment	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.
Quality of Life at follow-up assessment	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.

Trial Locations

Locations (1)

University Medicine Greifswald; 🇩🇪 Greifswald, Germany