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AphasiaPhase 2/3STARSNCT07688551

Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation

A Phase 2/3 study testing tDCS in people with Aphasia and Broca's Aphasia, run by University of South Carolina at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 80 years
Conditions the study is for
Aphasia, Broca's Aphasia
What is being tested?
tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
3 sitesUnited States
Study dates
14 Jul 2026to Jun 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Leonardo Bonilha contact

803-216-3469

Leonardo.Bonilha@uscmed.sc.edu

Julius Fridriksson contact

803-777-5931

fridriks@mailbox.sc.edu

United States3 sites, 3 recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Stephanie Cute, 843-548-7041, cute@musc.edu

    Janina Wilmskoetter

    Recruiting

  • University of South Carolina

    Columbia, South Carolina, 29201

    Allison Hare, allison.hare@sc.edu

    Leonardo Bonilha

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Robert Kraemer, Robert.Kraemer@hsc.utah.edu

    Robert Kraemer

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
tDCS
Keywords
tDCS, STARS, Aphasia, Stroke
Medical subject headings
Aphasia, Aphasia, Broca, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

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

Study groups in NCT07688551
Study groupRoleWhat they receive
1 mA A-tDCSActive comparatorNot described
Receives: Device: tDCS
2 mA A-tDCSActive comparatorNot described
Receives: Device: tDCS
S-tDCSSham comparatorNot described
Receives: Device: tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline assessment to 4-weeks post treatment

Secondary outcomes (7)

  1. 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.

    Measured: From baseline assessment to 1-week post treatment

  2. 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.

    Measured: From baseline assessment to 24-weeks post treatment

  3. 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).

    Measured: From baseline assessment to 4-weeks post treatment

  4. Functional Communication

    To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving functional communication.

    Measured: From baseline assessment to 4-weeks post treatment

  5. 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).

    Measured: From baseline assessment to 4-weeks post treatment

  6. Communication Confidence

    To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving communication confidence.

    Measured: From baseline assessment to 4-weeks post treatment

  7. Safety

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

    Measured: From baseline assessment to 4-weeks post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start14 Jul 2026
  3. Primary completionMar 2030 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase II: 1 mA, 2 mA, sham; Phase III: best mA dose, sham
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07688551
Sponsor's protocol ID
STUDY00000004
Other IDs
U01DC022447
Acronym
STARS
Status last verified
Jul 2026
First submitted
26 Jun 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.

    PubMed 20395612

  • Fridriksson J, Rorden C, Elm J, Sen S, George MS, Bonilha L. Transcranial Direct Current Stimulation vs Sham Stimulation to Treat Aphasia After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1470-1476. doi: 10.1001/jamaneurol.2018.2287.

    PubMed 30128538

  • Fridriksson J, Basilakos A, Stark BC, Rorden C, Elm J, Gottfried M, George MS, Sen S, Bonilha L. Transcranial direct current stimulation to treat aphasia: Longitudinal analysis of a randomized controlled trial. Brain Stimul. 2019 Jan-Feb;12(1):190-191. doi: 10.1016/j.brs.2018.09.016. Epub 2018 Sep 29. No abstract available.

    PubMed 30318184

  • Wilmskoetter J, Fridriksson J, Basilakos A, Phillip Johnson L, Marebwa B, Rorden C, Warner G, Hickok G, Hillis AE, Bonilha L. Indirect White Matter Pathways Are Associated With Treated Naming Improvement in Aphasia. Neurorehabil Neural Repair. 2021 Apr;35(4):346-355. doi: 10.1177/1545968321999052. Epub 2021 Mar 10.

    PubMed 33719732

  • Bonilha L, Rorden C, Roth R, Sen S, George MS, Fridriksson J. Improved naming in patients with Broca's aphasia with tDCS. J Neurol Neurosurg Psychiatry. 2024 Feb 14;95(3):273-276. doi: 10.1136/jnnp-2023-331541.

    PubMed 38071545

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing tDCS in people with Aphasia and Broca's Aphasia, run by University of South Carolina at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leonardo Bonilha (803-216-3469, Leonardo.Bonilha@uscmed.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Naming (time frame: From baseline assessment to 4-weeks post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07688551, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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