TY  - JOUR
U1  - Wissenschaftlicher Artikel
A1  - Stahl, Benjamin
A1  - Darkow, Robert
A1  - von Podewils, Viola
A1  - Meinzer, Marcus
A1  - Grittner, Ulrike
A1  - Reinhold, Thomas
A1  - Grewe, Tanja
A1  - Breitenstein, Caterina
A1  - Flöel, Agnes
T1  - Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia: A Randomized Controlled Trial Protocol
JF  - Frontiers in Neurology
N2  - 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. A sample of 130 individuals with aphasia at least 6 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.
Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03930121.
KW  - -
KW  - chronic post-stroke aphasia
KW  - intensive speech-language therapy
KW  - transcranial direct current stimulation
KW  - rehabilitation
KW  - randomized controlled trial
Y1  - 2019
UN  - https://nbn-resolving.org/urn:nbn:de:gbv:9-opus-32978
SN  - 1664-2295
SS  - 1664-2295
U6  - https://doi.org/10.3389/fneur.2019.01089
DO  - https://doi.org/10.3389/fneur.2019.01089
VL  - 10
PB  - Frontiers Media S.A.
ER  -