Abstract
IntroductionStroke 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.MethodsBased 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).PerspectiveThe 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 registrationClinical Trials Gov: NCT03185234, registered 14 June 2017 ; Deutsches Register für Klinische Studien: DRKS00012292, registered 01 June 2017.Trial statusParticipant enrollment began on 22 June 2017. The trial is expected to be completed on 30 June 2022.
Highlights
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
Studies in healthy subjects [18], apraxic stroke patients [1, 5], and patients with cortico-basal syndrome [3] showed an improvement in gesture processing and imitation by anodal transcranial direct current stimulation (tDCS) over the left posterior parietal cortex (PPC)
The randomized controlled trial (RCT) RAdiCS (Rehabilitating stroke-induced Apraxia with direct Current Stimulation) aims to investigate whether (in addition to motor training) repetitive anodal tDCS applied above the left, ipsilesional PPC can facilitate the recovery of the motor cognitive deficit apraxia during neurorehabilitation in the subacute to chronic phase after left hemisphere (LH) stroke
Summary
Aim of the trial A randomized controlled trial (RCT) on the utility of tDCS in apraxia is still missing. The null and alternative hypotheses are: H0: The change of the motor-cognitive apraxic deficits (as assessed by the KAS) between the baseline assessment and the post-interventional assessment is the same in both treatment groups (verum tDCS and sham tDCS). The secondary per-protocol (PP) collective includes all patients with a baseline and postinterventional KAS-score, plus the application of the verum or sham intervention according to the protocol, with the possibility of missing one stimulation, i.e., at least 4/5 stimulations must have been completed. The sham stimulation comprises identical fade-in and fade-out-periods (as anodal tDCS) with a short stimulation period of 20s in between, in which a current of 2 mA is applied This procedure renders the blinding more effective. In the process of randomization (see below), each participant is assigned to one of these codes, determining the
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