Effects of Transcranial Direct Current Stimulation (tDCS) on Language

August 18, 2023 updated by: Sara Pillay, Medical College of Wisconsin

Effects of tDCS in Language Recovery and Reorganization in Chronic 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

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 in a double-blind, partial crossover design. 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 or active-control anodal-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to either receive the tDCS intervention they did not already receive, within 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)

4

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 Contact

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a language deficit from focal neurologic damage (e.g. stroke, tumor).
  • Patients must be adults and have English-language fluency.
  • Patients must be eligible to undergo MRI.

Exclusion Criteria:

  • Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease) or neurologic disorder (e.g. idiopathic epilepsy, Parkinson's disease, ALS)
  • Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)
  • No 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, and inability to see or hear stimulus materials

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: Targeted tDCS with Phonologic-Focused Speech Therapy
Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before.
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. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the targeted region.
Other Names:
  • tDCS
  • HD-tDCS
Behavioral: Phonologic-Focused Speech Therapy
Participants are asked to generate or choose from a list phonologic information about a target picture.
Other Names:
  • Phonologic Component Analysis
Active Comparator: Active Control tDCS with Phonologic-Focused Speech Therapy
Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions.
Behavioral: Phonologic-Focused Speech Therapy
Participants are asked to generate or choose from a list phonologic information about a target picture.
Other Names:
  • Phonologic Component Analysis
Device: Active Control 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. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the active control region.
Other Names:
  • Active Control tDCS
  • Active Control HD-tDCS
Experimental: Targeted tDCS with Semantic-Focused Speech Therapy
Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions.
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. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the targeted region.
Other Names:
  • tDCS
  • HD-tDCS
Behavioral: Semantic-Focused Speech Therapy
Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
Other Names:
  • Semantic Feature Analysis
Active Comparator: Active Control tDCS with Semantic-Focused Speech Therapy
Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions.
Device: Active Control 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. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the active control region.
Other Names:
  • Active Control tDCS
  • Active Control HD-tDCS
Behavioral: Semantic-Focused Speech Therapy
Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
Other Names:
  • Semantic Feature Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline language performance on Picture Naming and Reading Tasks
Time Frame: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent improvement on lists 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

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
Rs-fMRI functional connectivity changes between time points at the site of stimulation will be assessed. Rs-FMRI functional connectivity changes between time points with the semantic network and between semantic network and perilesional phonological areas. Cortical activation patterns and ROI lateralization will be measured using an adaptive language mapping task-fMRI procedure. Activation patterns will be assessed for each task contrast within a set of ROIs thought to reflect the semantic and phonological network in healthy controls. Laterality indexes will be created using the same ROIs and their right-sided homologues to assess whether lateralization changes as a result of therapy.
3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance on functional outcome measures assessed through the language battery
Time Frame: 3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B
A full language battery assessing different language processes (phonology, semantics, orthography, comprehension, executive functioning, etc) will be repeated three times (Time 1, Time 2, Time 3), and change scores between times will be used to create behavioral variables for comparison of treatment effects. Change in functional rating between assessment times will be used to examine functional improvement as a result of intervention.
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

Investigators

  • Principal Investigator: Sara Pillay, PhD, 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)

December 1, 2019

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33162

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.

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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