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Effects of Transcranial Direct Current Stimulation (tDCS) on Language

Primary Purpose

Stroke, Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Transcranial Direct Current Stimulation
Active Control Transcranial Direct Current Stimulation
Phonologic-Focused Speech Therapy
Semantic-Focused Speech Therapy
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring tDCS, treatment, brain stimulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Targeted tDCS with Phonologic-Focused Speech Therapy

Active Control tDCS with Phonologic-Focused Speech Therapy

Targeted tDCS with Semantic-Focused Speech Therapy

Active Control tDCS with Semantic-Focused Speech Therapy

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

change from baseline language performance on Picture Naming and Reading Tasks
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.

Secondary Outcome Measures

fMRI
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.

Full Information

First Posted
November 8, 2019
Last Updated
August 18, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT04166513
Brief Title
Effects of Transcranial Direct Current Stimulation (tDCS) on Language
Official Title
Effects of tDCS in Language Recovery and Reorganization in Chronic Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 31, 2029 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
tDCS, treatment, brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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).
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Care provider, participant, and outcome assessor are masked for tDCS status.
Allocation
Randomized
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeted tDCS with Phonologic-Focused Speech Therapy
Arm Type
Experimental
Arm Description
Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before.
Arm Title
Active Control tDCS with Phonologic-Focused Speech Therapy
Arm Type
Active Comparator
Arm Description
Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions.
Arm Title
Targeted tDCS with Semantic-Focused Speech Therapy
Arm Type
Experimental
Arm Description
Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions.
Arm Title
Active Control tDCS with Semantic-Focused Speech Therapy
Arm Type
Active Comparator
Arm Description
Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions.
Intervention Type
Device
Intervention Name(s)
Targeted Transcranial Direct Current Stimulation
Other Intervention Name(s)
HD-tDCS, tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Active Control Transcranial Direct Current Stimulation
Other Intervention Name(s)
Active Control tDCS, Active Control HD-tDCS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Phonologic-Focused Speech Therapy
Other Intervention Name(s)
Phonologic Component Analysis
Intervention Description
Participants are asked to generate or choose from a list phonologic information about a target picture.
Intervention Type
Behavioral
Intervention Name(s)
Semantic-Focused Speech Therapy
Other Intervention Name(s)
Semantic Feature Analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
change from baseline language performance on Picture Naming and Reading Tasks
Description
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.
Time Frame
Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
Secondary Outcome Measure Information:
Title
fMRI
Description
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.
Time Frame
3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B
Other Pre-specified Outcome Measures:
Title
Performance on functional outcome measures assessed through the language battery
Description
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.
Time Frame
3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sidney Schoenrock
Phone
414-955-7579
Email
sschoenrock@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Pillay, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Drane, MS
Phone
414-955-5891
Email
sdrane@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Transcranial Direct Current Stimulation (tDCS) on Language

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