NCT07688551

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
46mo left

Started Jul 2026

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Jun 2030

First Submitted

Initial submission to the registry

June 26, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

July 14, 2026

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

3.6 years

First QC Date

June 26, 2026

Last Update Submit

July 20, 2026

Conditions

AphasiaBroca's Aphasia

Keywords

tDCSSTARSAphasiaStroke

Outcome Measures

Primary Outcomes (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.

    From baseline assessment to 4-weeks post treatment

Secondary Outcomes (7)

  • Naming

    From baseline assessment to 1-week post treatment

  • Naming

    From baseline assessment to 24-weeks post treatment

  • Aphasia Severity

    From baseline assessment to 4-weeks post treatment

  • Functional Communication

    From baseline assessment to 4-weeks post treatment

  • Quality of Life

    From baseline assessment to 4-weeks post treatment

  • +2 more secondary outcomes

Study Arms (3)

1 mA A-tDCS

ACTIVE COMPARATOR
Device: tDCS

2 mA A-tDCS

ACTIVE COMPARATOR
Device: tDCS

S-tDCS

SHAM COMPARATOR
Device: tDCS

Interventions

tDCSDEVICE

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

1 mA A-tDCS2 mA A-tDCSS-tDCS

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

University of South Carolina

Columbia, South Carolina, 29201, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 20395612BACKGROUND

  • 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.

    PMID: 30128538BACKGROUND

  • 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.

    PMID: 30318184BACKGROUND

  • 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.

    PMID: 33719732BACKGROUND

  • 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.

    PMID: 38071545BACKGROUND

MeSH Terms

Conditions

AphasiaAphasia, BrocaStroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Leonardo Bonilha

CONTACT

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

Julius Fridriksson

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase II: 1 mA, 2 mA, sham; Phase III: best mA dose, sham
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

June 26, 2026

First Posted

July 7, 2026

Study Start

July 14, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations

US(3)