The purpose of this study is to help us understand if adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.
This project is a prospective randomized controlled double-blinded clinical trial to compare auditory-visual speech therapy coupled with adjuvant active anodal tDCS (A-tDCS) versus speech therapy coupled with sham tDCS (S-tDCS). The investigators will perform an adaptive Phase II/III design, in which the first portion of the study (Phase II) will determine the optimal dose of A-tDCS (1 mA versus 2 mA) and provide a go/no-go decision for Phase III. The investigators will use a 10-10 system to determine electrode placement, with 5 x 5 cm pads, and stimulation duration will be 20 minutes. Phase III will test the definitive superiority of adjuvant A-tDCS at the optimal dose coupled with speech therapy versus speech therapy alone (S-tDCS) to improve naming among individuals with chronic Broca's aphasia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).
Medical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGUniversity of South Carolina
Columbia, South Carolina, United States
RECRUITINGUniversity of Utah
Salt Lake City, Utah, United States
RECRUITINGNaming
Change in the number of correctly named items between the average of the two pre-treatment Philadelphia Naming Test (PNT) assessments and the average of the two post-treatment PNT sessions at 4-weeks post treatment.
Time frame: From baseline assessment to 4-weeks post treatment
Naming
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 1-week post treatment.
Time frame: From baseline assessment to 1-week post treatment
Naming
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 24-weeks post treatment.
Time frame: From baseline assessment to 24-weeks post treatment
Aphasia Severity
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in reducing aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ).
Time frame: From baseline assessment to 4-weeks post treatment
Functional Communication
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving functional communication.
Time frame: From baseline assessment to 4-weeks post treatment
Quality of Life
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving quality of life as measured by the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39).
Time frame: From baseline assessment to 4-weeks post treatment
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Communication Confidence
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving communication confidence.
Time frame: From baseline assessment to 4-weeks post treatment
Safety
To demonstrate safety differences (proportion of new adverse events) between groups.
Time frame: From baseline assessment to 4-weeks post treatment