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Journal Article

Transcranial direct current stimulation to enhance training effectiveness in chronic post-stroke aphasia: A randomized controlled trial protocol


Stahl,  Benjamin
Department of Neurology, Ernst Moritz Arndt University of Greifswald, Germany;
Department of Neurology, Charité University Medicine Berlin, Germany;
Department Neurophysics (Weiskopf), MPI for Human Cognitive and Brain Sciences, Max Planck Society;

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Stahl, B., Darkow, R., von Podewils, V., Meinzer, M., Grittner, U., Reinhold, T., et al. (2019). Transcranial direct current stimulation to enhance training effectiveness in chronic post-stroke aphasia: A randomized controlled trial protocol. Frontiers in Neurology, 10: 1089. doi:10.3389/fneur.2019.01089.

Cite as: https://hdl.handle.net/21.11116/0000-0004-D390-A
Background. Intensive speech-language therapy (SLT) can promote recovery from chronic post-stroke aphasia, a major consequence of stroke. However, effect sizes of intensive SLT are moderate, potentially reflecting a physiological limit of training-induced progress. Transcranial direct current stimulation (tDCS) is an easy-to-use, well-tolerated and low-cost approach that may enhance effectiveness of intensive SLT. In a recent phase-II randomized controlled trial, 26 individuals with chronic post-stroke aphasia received intensive SLT combined with anodal-tDCS of the left primary motor cortex (M1), resulting in improved naming and proxy-rated communication ability, with medium-to-large effect sizes.

Aims. The proposed protocol seeks to establish the incremental benefit from anodal-tDCS of M1 in a phase-III randomized controlled trial with adequate power, ecologically valid outcomes, and evidence-based SLT.

Methods. The planned study is a prospective randomized placebo-controlled (using sham-tDCS), parallel-group, double-blind, multi-center, phase-III superiority trial. 130 individuals with aphasia at least six months post-stroke will be recruited in more than 18 in- and outpatient rehabilitation centers.

Outcomes. The primary outcome focuses on communication ability in chronic post-stroke aphasia, as revealed by changes on the Amsterdam-Nijmegen Everyday Language Test (A-scale; primary endpoint: 6-month follow-up; secondary endpoints: immediately after treatment, and 12-month follow-up). Secondary outcomes include measures assessing linguistic-executive skills, attention, memory, emotional well-being, quality of life, health economic costs, and adverse events (endpoints: 6-month follow up, immediately after treatment, and 12-month follow-up).

Discussion. Positive results will increase the quality of life for persons with aphasia and their families while reducing societal costs. After trial completion, a workshop with relevant stakeholders will ensure transfer into best-practice guidelines and successful integration within clinical routine.