Effects of Transcranial Direct Current Stimulation (tDCS) on Language
NCT ID: NCT04166513
Last Updated: 2025-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2019-12-13
2024-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Targeted tDCS with Phonologic-Focused Speech Therapy
Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before.
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.
Phonologic-Focused Speech Therapy
Participants are asked to generate or choose from a list phonologic information about a target picture.
Active Control tDCS with Phonologic-Focused Speech Therapy
Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions.
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.
Phonologic-Focused Speech Therapy
Participants are asked to generate or choose from a list phonologic information about a target picture.
Targeted tDCS with Semantic-Focused Speech Therapy
Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions.
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.
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.
Active Control tDCS with Semantic-Focused Speech Therapy
Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions.
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.
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.
Interventions
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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.
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.
Phonologic-Focused Speech Therapy
Participants are asked to generate or choose from a list phonologic information about a target picture.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be adults and have English-language fluency.
* Patients must be eligible to undergo MRI.
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Sara Pillay
Assistant Professor
Principal Investigators
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Sara Pillay, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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33162
Identifier Type: -
Identifier Source: org_study_id
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