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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04944147
• Other study ID #: Neuromod-COV
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: University Medicine Greifswald
• Contact: Agnes Flöel, Prof.
• Phone: 0049 3834 86 6815
• Email: agnes.floeel[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• COVID-19

Intervention

Device:
• Anodal tDCS
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA)
• Sham tDCS
Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants

Behavioral:
• Intensive cognitive training
Intensive cognitive training of a letter memory updating task, 9 sessions
• Progressive muscle relaxation (PMR)
Standardized instructed PMR training, 9 sessions

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Working memory performance at post-assessment	Percent change of correct responses in the n-back task compared to the pre-training assessment.	3 weeks
Secondary	Working memory performance at follow-up assessment	Percent change of correct responses in the n-back task compared to the pre-training assessment.	4 weeks after training
Secondary	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.	3 weeks
Secondary	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.	4 weeks after training
Secondary	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.	3 weeks
Secondary	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.	4 weeks after training
Secondary	Visuo-spatial performance at post-assessment	Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.	3 weeks
Secondary	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.	4 weeks after training
Secondary	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).	3 weeks
Secondary	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).	4 weeks after training