Effects of Transcranial Direct Current Stimulation (tDCS) on Language

NCT04166513 | Completed Results FDA Device

• 1 other identifier: 33162
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Aphasia

Keywords

tDCS; treatment; brain stimulation

Outcome Measures

Primary Outcomes (1)

• Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)

  Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct). There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs. Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A. Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A.

  Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post

Secondary Outcomes (3)

• fMRI- Baseline

  Baseline

• fMRI After Cycle A

  10-weeks post Cycle A

• fMRI Post Cycle B

  10 weeks post cycle B

Other Outcomes (1)

• Performance on Outcome Measures Assessed Through the Language Battery

  3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B

Study Arms (4)

Targeted tDCS with Phonologic-Focused Speech Therapy

EXPERIMENTAL

Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before.

Device: Targeted Transcranial Direct Current Stimulation; Behavioral: Phonologic-Focused Speech Therapy

Active Control tDCS with Phonologic-Focused Speech Therapy

ACTIVE COMPARATOR

Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions.

Device: Active Control Transcranial Direct Current Stimulation; Behavioral: Phonologic-Focused Speech Therapy

Targeted tDCS with Semantic-Focused Speech Therapy

EXPERIMENTAL

Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions.

Device: Targeted Transcranial Direct Current Stimulation; Behavioral: Semantic-Focused Speech Therapy

Active Control tDCS with Semantic-Focused Speech Therapy

ACTIVE COMPARATOR

Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions.

Device: Active Control Transcranial Direct Current Stimulation; Behavioral: Semantic-Focused Speech Therapy

Interventions

Targeted Transcranial Direct Current Stimulation DEVICE

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.

Also known as: HD-tDCS, tDCS

Targeted tDCS with Phonologic-Focused Speech Therapy; Targeted tDCS with Semantic-Focused Speech Therapy

Active Control Transcranial Direct Current Stimulation DEVICE

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.

Also known as: Active Control tDCS, Active Control HD-tDCS

Active Control tDCS with Phonologic-Focused Speech Therapy; Active Control tDCS with Semantic-Focused Speech Therapy

Phonologic-Focused Speech Therapy BEHAVIORAL

Participants are asked to generate or choose from a list phonologic information about a target picture.

Also known as: Phonologic Component Analysis

Active Control tDCS with Phonologic-Focused Speech Therapy; Targeted tDCS with Phonologic-Focused Speech Therapy

Semantic-Focused Speech Therapy BEHAVIORAL

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.

Also known as: Semantic Feature Analysis

Active Control tDCS with Semantic-Focused Speech Therapy; Targeted tDCS with Semantic-Focused Speech Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (43)

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MeSH Terms

Conditions

Stroke; Aphasia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Sara Pillay
• Organization: Medical College of Wisconsin

Sapillay@mcw.edu

414-955-4482

Study Officials

• Sara Pillay, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care provider, participant, and outcome assessor are masked for tDCS status.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Partial crossover design. Participants will maintain one of two speech therapy modalities throughout the study, but will crossover from targeted to active control stimulation (or vice versa).

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 18, 2019
• Study Start: December 13, 2019
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 3, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)