Recruiting
Phase 2
Phase 3

tDCS & Speech Therapy

Sponsor:

University of South Carolina

Code:

NCT07688551

Conditions

Aphasia

Broca's Aphasia

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

tDCS

Study Details

Brief 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.

Conditions

Aphasia

Broca's Aphasia

Study ID

NCT07688551

Start date

Jul 14, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1 mA A-tDCS

active comparator: 2 mA A-tDCS

sham comparator: S-tDCS

Interventions

tDCS

The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).

Primary outcome measure

  • Naming [ Time Frame: From baseline assessment to 4-weeks post treatment ]

Central Contacts and Locations

Central contacts

Leonardo Bonilha

803-216-3469Leonardo.Bonilha@uscmed.sc.edu

Julius Fridriksson

803-777-5931fridriks@mailbox.sc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Stephanie Cute

843-548-7041cute@musc.edu

Principal Investigator:

Janina Wilmskoetter

University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29201

Contacts

Allison Hare

allison.hare@sc.edu

Principal Investigator:

Leonardo Bonilha

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Robert Kraemer

Robert.Kraemer@hsc.utah.edu

Principal Investigator:

Robert Kraemer

More Information

Sponsor

University of South Carolina

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • tDCS
  • STARS
  • Aphasia
  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of South Carolina on 2026-07-21.