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NCT07688551PHASE2, PHASE3Recruiting

Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation

University of South Carolina

Start Date

7/14/2026

Completion Date

6/1/2030

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 25 years to 80 years

Inclusion Criteria: * Be willing and able to give informed consent. * Be willing and able to comply with study requirements. * Be between 25 and 80 years of age. * Have used English as the primary language for \> 15 years. * Have the diagnosis of aphasia due to a left hemisphere stroke, confirmed by study physician based on past clinical MRI scan or research scan. * Be greater than 6 months post-stroke. * Have Broca's aphasia diagnosed by the WAB-R (fluency score ≤ 5, auditory verbal comprehension score 4-10, repetition score 0-7.9, naming and word finding score \< 9). * Correctly name 140 or fewer items on the PNT. Exclusion Criteria: * History of brain surgery except for during the treatment of the acute stroke. * Seizures during the previous 12-months. * Compromised skin at or near electrode sites (e.g., rash, eczema, wounds, infection). * Correctly name more than 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test). * Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) score of 25 or below. * Participants with open skull defects (e.g., greater than 1 cm) in the area underneath the anode electrode positioning or participants with metal implants or electrical stimulators. * Participants with continuous oxygen therapy which cannot be discontinued for more than 1 hour. * Any condition or situation that the PI determines would significantly interfere with the participant's ability to complete the study.

Interventions

DEVICE

tDCS

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Conditions

AphasiaBroca's Aphasia

Locations

Medical University of South Carolina

Charleston, South Carolina 29425

United States

University of South Carolina

Columbia, South Carolina 29201

United States

University of Utah

Salt Lake City, Utah 84112

United States