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NCT Number: NCT07688551

Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation

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.

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Medical University of South Carolina, Charleston, South Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tDCS

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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.

  7. Safety

    Time frame: From baseline assessment to 4-weeks post treatment

    To demonstrate safety differences (proportion of new adverse events) between groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Julius Fridriksson

CONTACT

[email protected]

803-777-5931

Leonardo Bonilha

CONTACT

[email protected]

803-216-3469

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Transcranial Direct Current Stimulation to Treat Aphasia: A Superiority Study

Acronym: STARS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 7, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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