A Phase 2/3 interventional study of tDCS in Aphasia and Broca's Aphasia, sponsored by University of South Carolina. Recruiting at 3 sites in United States. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of South Carolina · Phase 2/3, Interventional, and Treatment
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.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's planned enrollment of 130 is above the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: tDCS
Device: tDCS
Device: tDCS
The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).
Naming
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
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
Started Jul 2026 (actual). Primary completion is estimated for Mar 2030, 44 months after the start.
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