HD-tDCS for Phonological Impairment in Aphasia

March 11, 2026 updated by: Priyanka Shah-Basak, PhD, Medical College of Wisconsin

A Randomized Clinical Trial of tDCS to Remediate Phonological Impairment in Aphasia

This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS).

This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy.

Study design:

Patients will be randomly assigned to one of 2 speech therapy groups as well as randomly assigned to one of 2 stimulation groups (active anodal stimulation or sham). Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted anodal-tDCS or sham-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to receive the tDCS intervention again, along with the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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:

  • Patients must be 18 or older.

Patients may not be older than 85.

Patients must have a language deficit from left-sided focal neurologic damage (e.g. stroke, tumor).

Patients must be adults and have English-language fluency.

Patients must be eligible to undergo MRI.

Beyond meeting the inclusion criteria, no preference will be given on the basis of race, ethnicity or gender.

Exclusion Criteria:

  • Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease)

Neurologic disease (e.g. idiopathic epilepsy, seizure disorders that are not well managed, Parkinson's disease, ALS),

Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)

Suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability).

Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, inability to see or hear stimulus materials.

Younger than 18 or older than 85.

< 6 months post tumor resection.

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HD-tDCS
Participants will be randomized to receive either anodal HD-tDCS or sham-tDCS.
Device: Targeted Transcranial Direct Current Stimulation
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. Anodal or sham tDCS will be administered.
Other Names:
  • tDCS
  • HD-tDCS
Experimental: Speech Therapy
Participants will be randomized to receive either phonologic-focused speech therapy or semantic-focused speech therapy
Behavioral: Speech Therapy
Participants will receive either semantic or phonological focused speech therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral outcome
Time Frame: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post completion of therapy
Percent improvement on behavioral outcomes after each therapy cycle will be the primary behavioral outcome measure.
Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post completion of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fMRI
Time Frame: 3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B
fMRI functional changes between time points
3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B

Collaborators and Investigators

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

Sponsor

Medical College of Wisconsin

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)

October 3, 2023

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

January 1, 2033

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00046308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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