Neuromodulation through brain stimulation-assisted cognitive training in patients with post-COVID-19 cognitive impairment (Neuromod-COV): study protocol for a PROBE phase IIb trial.

Abstract

INTRODUCTION:

A substantial number of patients diagnosed with COVID-19 experience long-term persistent symptoms. First evidence suggests that long-term symptoms develop largely independently of disease severity and include, among others, cognitive impairment. For these symptoms, there are currently no validated therapeutic approaches available. Cognitive training interventions are a promising approach to counteract cognitive impairment. Combining training with concurrent transcranial direct current stimulation (tDCS) may further increase and sustain behavioural training effects. Here, we aim to examine the effects of cognitive training alone or in combination with tDCS on cognitive performance, quality of life and mental health in patients with post-COVID-19 subjective or objective cognitive impairments.

METHODS AND ANALYSIS:

This study protocol describes a prospective randomised open endpoint-blinded trial. Patients with post-COVID-19 cognitive impairment will either participate in a 3-week cognitive training or in a defined muscle relaxation training (open-label interventions). Irrespective of their primary intervention, half of the cognitive training group will additionally receive anodal tDCS, all other patients will receive sham tDCS (double-blinded, secondary intervention). The primary outcome will be improvement of working memory performance, operationalised by an n-back task, at the postintervention assessment. Secondary outcomes will include performance on trained and untrained tasks and measures of health-related quality of life at postassessment and follow-up assessments (1 month after the end of the trainings).

ETHICS AND DISSEMINATION:

Ethical approval was granted by the Ethics Committee of the University Medicine Greifswald (number: BB 066/21). Results will be available through publications in peer-reviewed journals and presentations at national and international conferences.

TRIAL REGISTRATION NUMBER:

NCT04944147.

• Authors: Friederike Thams, Daria Antonenko, Robert Fleischmann, Marcus Meinzer, Ulrike Grittner, Sein Schmidt, Eva-Lotta Brakemeier, Anke Steinmetz, Agnes Flöel
• Journal: BMJ open (BMJ Open) Vol. 12 Issue 4 Pg. e055038 (04 11 2022) ISSN: 2044-6055 [Electronic] England
• PMID: 35410927 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Topics

• Brain
• COVID-19 (therapy)
• Clinical Trials, Phase II as Topic
• Cognition
• Cognitive Dysfunction (therapy)
• Humans
• Prospective Studies
• Quality of Life
• Randomized Controlled Trials as Topic
• Transcranial Direct Current Stimulation