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Clinical Trials/NCT04944147
NCT04944147
Completed
N/A

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

University Medicine Greifswald1 site in 1 country60 target enrollmentJanuary 5, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
COVID-19
Sponsor
University Medicine Greifswald
Enrollment
60
Locations
1
Primary Endpoint
Working memory performance at post-assessment
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2022
End Date
October 8, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Medicine Greifswald
Responsible Party
Sponsor

Eligibility Criteria

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-
  • 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).

Outcomes

Primary Outcomes

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

  • Post COVID-19 Function at follow-up assessment(4 weeks after training)
  • Visuo-spatial performance at post-assessment(3 weeks)
  • Working memory performance at follow-up assessment(4 weeks after training)
  • Working memory training performance (Letter Updating Task) at post-assessment(3 weeks)
  • Quality of Life at post-assessment(3 weeks)
  • Visuo-spatial performance at follow-up assessment(4 weeks after training)
  • Post COVID-19 Function at post-assessment(3 weeks)
  • Working memory training performance (Letter Updating Task) at follow-up assessment(4 weeks after training)
  • Quality of Life at follow-up assessment(4 weeks after training)

Study Sites (1)

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