Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation (STARS)

July 20, 2026 updated by: Leonardo Bonilha, University of South Carolina

Transcranial Direct Current Stimulation to Treat Aphasia: A Superiority Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Janina Wilmskoetter
        • Sub-Investigator:
          • Christy Cassarly
        • Contact:
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • University of South Carolina
        • Contact:
        • Principal Investigator:
          • Leonardo Bonilha
        • Principal Investigator:
          • Julius Fridriksson
        • Sub-Investigator:
          • Chris Rorden
        • Sub-Investigator:
          • Roger Newman-Norlund
        • Sub-Investigator:
          • James Hardin
        • Sub-Investigator:
          • Samaneh Nemati
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Robert Kraemer
        • Sub-Investigator:
          • Julie Wambaugh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 mA A-tDCS
Device: tDCS
The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).
Active Comparator: 2 mA A-tDCS
Device: tDCS
The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).
Sham Comparator: S-tDCS
Device: tDCS
The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Naming
Time Frame: From baseline assessment to 4-weeks post treatment
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.
From baseline assessment to 4-weeks post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Naming
Time Frame: From baseline assessment to 1-week post treatment
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 1-week post treatment.
From baseline assessment to 1-week post treatment
Naming
Time Frame: From baseline assessment to 24-weeks post treatment
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 24-weeks post treatment.
From baseline assessment to 24-weeks post treatment
Aphasia Severity
Time Frame: From baseline assessment to 4-weeks post treatment
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).
From baseline assessment to 4-weeks post treatment
Functional Communication
Time Frame: From baseline assessment to 4-weeks post treatment
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving functional communication.
From baseline assessment to 4-weeks post treatment
Quality of Life
Time Frame: From baseline assessment to 4-weeks post treatment
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).
From baseline assessment to 4-weeks post treatment
Communication Confidence
Time Frame: From baseline assessment to 4-weeks post treatment
To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving communication confidence.
From baseline assessment to 4-weeks post treatment
Safety
Time Frame: From baseline assessment to 4-weeks post treatment
To demonstrate safety differences (proportion of new adverse events) between groups.
From baseline assessment to 4-weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000004
  • U01DC022447 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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