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

University Medicine Greifswald

Status: Completed

Conditions: COVID-19; Post-COVID-19

Treatments: Behavioral: Intensive cognitive training; Device: Anodal tDCS; Behavioral: Progressive muscle relaxation (PMR); Device: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04944147

Neuromod-COV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Anodal tDCS + cognitive training

Experimental group

Description:

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

Treatment:

Device: Anodal tDCS

Behavioral: Intensive cognitive training

Sham tDCS + cognitive training

Placebo Comparator group

Description:

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

Treatment:

Device: Sham tDCS

Behavioral: Intensive cognitive training

Sham tDCS + Progressive Muscle Relaxation training

Active Comparator group

Description:

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

Treatment:

Device: Sham tDCS

Behavioral: Progressive muscle relaxation (PMR)