Basic informations

Investigator: doc. MUDr. Monika Klírová, Ph.D.
Main recipient: National Institute of Mental Health (NIMH)
Research period: 1/4/2022 - 31/12/2023
Total budget: 4,086,000 CZK
Supported by: Czech Health Research Council (AZV ČR)

Annotation

The main aim of this project is to evaluate the clinical efficacy and safety of transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) in the treatment of neuropsychiatric symptoms of the post-acute sequelae of SARS-CoV-2 infection (PASC). The primary objective of the double-blind, randomized, placebo-controlled, parallel study with four-week follow-up is to compare the efficacy (response to the treatment, effect duration) and safety of 4-week active DLPFC-tDCS (20 tDCS applications with anode placement at F3; 2 mA, 30 min/tDCS session) to placebo-tDCS in the treatment of neuropsychiatric symptoms of PASC. The primary study outcome is a change in validated Czech version of the “Fatigue Impact Scale“ (FIS) after the acute phase of the study and after the follow-up. Secondary outcomes will cover 1) the change in the following measurements: a) functional ability, cognitive functions, and emotional symptoms subscales of the “Post-COVID-19 Symptoms Assessment Questionnaire“ (A-PASC), b) self-assessment scales of depressive and anxiety symptoms (PHQ-9; GAD-7), c) cognitive testing focused on attention, working memory, and psychomotor pace, d) quality of life monitoring based on the AQOL-6D questionnaire after the acute phase of the study and after the follow-up, and 2) evaluation of tDCS side effects during tDCS treatment. The secondary outcomes will target the electrophysiological (EEG) parameters associated with PASC and their changes after the intervention with respect to the assigned group and response rate (specifically qEEG cordance, EEG microstates, and functional connectivity will be evaluated).