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HD-tDCS for Phonological Impairment in Aphasia

Primary Purpose

Aphasia, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Transcranial Direct Current Stimulation
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 Aphasia

Eligibility Criteria

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

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.

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HD-tDCS

Speech Therapy

Arm Description

Participants will be randomized to receive either anodal HD-tDCS or sham-tDCS.

Participants will be randomized to receive either phonologic-focused speech therapy or semantic-focused speech therapy

Outcomes

Primary Outcome Measures

Behavioral outcome
Percent improvement on behavioral outcomes after each therapy cycle will be the primary behavioral outcome measure.

Secondary Outcome Measures

fMRI
fMRI functional changes between time points

Full Information

First Posted
August 18, 2023
Last Updated
August 23, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT06010030
Brief Title
HD-tDCS for Phonological Impairment in Aphasia
Official Title
A Randomized Clinical Trial of tDCS to Remediate Phonological Impairment in Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Anticipated)
Primary Completion Date
January 1, 2033 (Anticipated)
Study Completion Date
January 1, 2033 (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
Product Manufactured in and Exported from the U.S.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will maintain one of two speech therapy modalities throughout the study and be assigned to either targeted anodal-tDCS or sham-tDCS.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Care provider, participant, and outcome assessor are masked for tDCS status.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HD-tDCS
Arm Type
Experimental
Arm Description
Participants will be randomized to receive either anodal HD-tDCS or sham-tDCS.
Arm Title
Speech Therapy
Arm Type
Experimental
Arm Description
Participants will be randomized to receive either phonologic-focused speech therapy or semantic-focused speech therapy
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. Anodal or sham tDCS will be administered.
Intervention Type
Behavioral
Intervention Name(s)
Speech Therapy
Intervention Description
Participants will receive either semantic or phonological focused speech therapy
Primary Outcome Measure Information:
Title
Behavioral outcome
Description
Percent improvement on behavioral outcomes 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 completion of therapy
Secondary Outcome Measure Information:
Title
fMRI
Description
fMRI functional changes between time points
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sidney E Schoenrock, MA
Phone
414-955-7579
Email
sschoenrock@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Pillay, Ph.D
Phone
414-955-4482
Email
sapillay@mcw.edu
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
Sidney E Schoenrock, MA
Phone
414-955-7579
Email
sschoenrock@mcw.edu
First Name & Middle Initial & Last Name & Degree
Sara Pillay, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No
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HD-tDCS for Phonological Impairment in Aphasia

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