Abstract
BackgroundTranscranial direct current stimulation (tDCS) is a promising new technique to optimize the effect of regular Speech and Language Therapy (SLT) in the context of aphasia rehabilitation. The present study focuses on the effect of tDCS provided during SLT in the sub-acute stage after stroke. The primary aim is to evaluate the potential effect of tDCS on language functioning, specifically on word-finding, as well as generalization effects to verbal communication. The secondary aim is to evaluate its effect on social participation and quality of life, and its cost-effectiveness.MethodsWe strive to include 58 stroke patients with aphasia, enrolled in an inpatient or outpatient stroke rehabilitation program, in a multicenter, double-blind, randomized controlled trial with two parallel groups and 6 months’ follow-up. Patients will participate in two separate intervention weeks, with a pause of 2 weeks in between, in the context of their regular aphasia rehabilitation program. The two intervention weeks comprise daily 45-minute sessions of word-finding therapy, combined with either anodal tDCS over the left inferior frontal gyrus (1 mA, 20 minutes; experimental condition) or sham-tDCS over the same region (control condition). The primary outcome measure is word-finding. Secondary outcome measures are verbal communication, social participation, quality of life, and cost-effectiveness of the intervention.DiscussionOur results will contribute to the discussion on whether tDCS should be implemented in regular aphasia rehabilitation programs for the sub-acute post-stroke population in terms of (cost-)effectiveness.Trial registrationNederlands Trail Register: NTR4364. Registered on 21 February 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1505-z) contains supplementary material, which is available to authorized users.
Highlights
Transcranial direct current stimulation is a promising new technique to optimize the effect of regular Speech and Language Therapy (SLT) in the context of aphasia rehabilitation [5]
The present study focuses on the effect of Transcranial direct current stimulation (tDCS) provided during SLT in the sub-acute stage after stroke
The primary aim is to evaluate the potential effect of tDCS on language functioning, on word-finding, as well as generalization effects to verbal communication
Summary
Study design and procedure The study is a multicenter, double-blind, randomized controlled trial with two parallel groups and 6-month follow-up. Regular SLT sessions are replaced by daily 45-minute sessions of word-finding therapy, combined with either anodal tDCS over the left IFG (1 mA, 20 minutes; experimental condition) or sham-tDCS over the same region (control condition). To randomize participants to the experimental or control condition, we use a list of five-number codes, provided by the manufacturer of the stimulation device. Intervention In each intervention week, regular SLT sessions are replaced by daily 45-minute sessions of word-finding therapy, combined with either anodal tDCS over the left IFG (1 mA, 20 minutes; experimental condition) or sham-tDCS over the same region (control condition). Secondary outcome measures are chosen to evaluate generalization of treatment effects to verbal communication: the Aphasia Severity Rating Scale (ASRS) [41] to assess spontaneous speech and the Amsterdam Nijmegen Everyday Language Test (ANELT) [42] as a measure for verbal communication in everyday life. The economic evaluation will be performed following the Dutch guidelines [53]
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