Verum versus sham tDCS in the treatment of stroke-induced apraxia: Study protocol of the randomized controlled trial RAdiCS -"Rehabilitating (stroke-induced) Apraxia with direct Current Stimulation"

Abstract

Introduction: Stroke is the leading cause of acquired disability in western societies. (Motor) cognitive deficits like apraxia significantly contribute to disability after stroke, harming activities of daily living and rehabilitation outcome. To date, efficient therapeutic options for apraxia remain sparse. Thus, randomized controlled trials (RCTs) are warranted. Methods: Based on promising results of a pilot study, the on-going RAdiCS (Rehabilitating stroke-induced Apraxia with direct Current Stimulation) study is a randomized controlled trial, which follows a double-blinded (investigator and patient), two-arm parallel interventional model. It is designed to include 110 apraxic patients (as diagnosed by the Cologne Apraxia Screening, KAS) in the subacute phase after a left hemisphere (LH) stroke. The University of Cologne initiated the trial, which is conducted in two German Neurorehabilitation Centers. The study aims to evaluate the effect of anodal (versus sham) transcranial direct current stimulation (tDCS) applied over the left posterior parietal cortex (PPC) with an intensity of 2 mA for 10 min on five consecutive days on apraxic deficits. In addition to anodal or sham tDCS, all LH stroke patients undergo a motor (cognitive) training that is performed before and after the stimulation (off-line stimulation). The primary outcome measure is the (differential) change in the overall KAS score after five daily sessions of anodal versus sham tDCS when compared to the baseline assessment before tDCS. Secondary study outcomes include further apraxia scores, aphasia severity, and measures of motor performance and disability after stroke. All outcome measures are obtained in the post-stimulation assessment as well as during follow-up (3-4 months after tDCS). Perspective: The RCT RAdiCS shall evaluate in a large number of LH stroke patients whether anodal tDCS (compared to sham tDCS) expedites the rehabilitation of apraxia - over and above additional motor (cognitive) training and standard care. A positive study outcome would provide a new strategy for the treatment of apraxia, which hopefully ameliorates the negative impact of apraxia on daily living and long-term outcome. Trial registration: Clinical Trials Gov: NCT03185234, registered 14 June 2017; Deutsches Register für Klinische Studien: DRKS00012292, registered 01 June 2017. Trial status: Participant enrollment began on 22 June 2017. The trial is expected to be completed on 30 June 2022.