Treatment Outcomes With tDCS in Post-Stroke Aphasia
Primary Purpose
Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial Direct Current Stimulation with SLT
Sham Transcranial Direct Current Stimulation with SLT
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia
Eligibility Criteria
Inclusion Criteria:
- Presence of post-stroke aphasia
- Single left hemisphere stroke etiology
- At least 6 months post-stroke
- Age range between 18 and 80 years old
- Speak English as a native language
- Adequate hearing and vision to complete the tasks
Exclusion Criteria:
- Severe auditory comprehension deficits (determined by pretest) (i.e., global aphasia, Wernicke's aphasia, transcortical sensory aphasia)
- Inability to provide informed consent
- Co-occurring history of neurological disease/disorder/injury (e.g., traumatic brain injury, right hemisphere stroke, dementia)
- Co-occurring history of a major mental illness (e.g., schizophrenia, drug addiction, bipolar)
- Clinical conditions contraindicated for MRI or tDCS (e.g., implanted electrical devices, claustrophobia, seizure disorder)
- Positive pregnancy test (for females)
Sites / Locations
- University of Arkansas for Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active tDCS (with Speech-Language Treatment)
Sham tDCS (with Speech-Language Treatment)
Arm Description
tDCS Stimulation Dose: 1.5 mA for 20-mins
No tDCS stimulation
Outcomes
Primary Outcome Measures
Change in correct naming of nouns on Philadelphia Naming Test.
Naming gains for untreated items.
Secondary Outcome Measures
Change in correct naming of verbs on Action Naming Test
Naming gains for untreated items.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03929432
Brief Title
Treatment Outcomes With tDCS in Post-Stroke Aphasia
Official Title
Treatment Outcomes and Brain Mechanisms Associated With Non-Invasive Neuromodulation in Post-Stroke Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose this study is to test the utility of pairing external neuromodulation with behavioral language treatment to boost therapy outcomes and to investigate the mechanisms associated with recovery. Because all PWA have word retrieval deficits, this project will test if greater language gains can be achieved by supplementing anomia intervention with excitatory brain stimulation to the left hemisphere and will evaluate associated functional brain changes to aid the optimization of neural reorganization to facilitate language processing.
Detailed Description
Aphasia is a language impairment that commonly occurs following brain damage (e.g., stroke). While language rehabilitation can yield improved language functioning, treatment outcomes vary greatly across individuals. In chronic aphasia, language gains occur through the brain's inherent ability to reorganize (i.e., neuroplasticity).
While Speech-language therapy (SLT) can target various language skills and modalities, the most pervasive deficit across all persons with aphasia (PWA) is difficulty with word finding. Thus, aphasia treatment often includes some form of intervention focused on improving naming abilities. As with language function in general, naming abilities in PWA seems to be associated with left hemisphere recruitment, particularly with the viable tissue at the rim of the lesion (perilesional areas). This project investigates an innovative approach to improving current therapy by examining the benefits of using excitatory transcranial direct current stimulation (tDCS) stimulation/neuromodulation during anomia treatment (i.e. word-finding treatment).
This study investigates an innovative approach to improving current therapy by examining the benefits of using excitatory tDCS stimulation/neuromodulation during anomia treatment. This project will provide novel mechanistic understanding of changes in functional brain connectivity in persons with post-stroke aphasia and how connectivity relates to treatment outcomes.
The aims of this study are as follows:
Aim 1. To investigate the benefits of using broad transcranial direct current stimulation (tDCS) to improve word retrieval in persons with aphasia (PWA). Aim 2. To study functional brain changes related to this treatment. Aim 3. To examine behavioral and neural re-organization correlates related to treatment outcomes.
All participants will complete the following 3 components: (1) Baseline Assessment, (2) Interventions (i.e., SLT with active tDCS & sham tDCS , and (3) Outcome Testing (i.e., Behavioral & Brain Imaging). During the first week, each participant will complete all of the Neuropsychological Testing Battery and the first round of the outcome measures as pre-testing before starting SLT. Then the participant will complete 2 weeks of SLT accompanied with either active tDCS or sham tDCS. Once the SLT is completed, the participant will complete round 2 of outcome testing (i.e., post-testing for 1st SLT phase and pre-testing for 2nd SLT phase). Then, the participant will complete another 2 weeks of SLT but with the other tDCS condition. Once SLT is completed, the participant will complete round 3 of outcome testing (i.e., post-testing for 2nd SLT phase). Lastly, the participant will complete round 4 of outcome testing (i.e., follow-up)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Active tDCS versus sham tDCS will be masked to the participants
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS (with Speech-Language Treatment)
Arm Type
Active Comparator
Arm Description
tDCS Stimulation Dose: 1.5 mA for 20-mins
Arm Title
Sham tDCS (with Speech-Language Treatment)
Arm Type
Sham Comparator
Arm Description
No tDCS stimulation
Intervention Type
Device
Intervention Name(s)
Active Transcranial Direct Current Stimulation with SLT
Intervention Description
Soterix Medical 1×1 transcranial Direct Current Stimulator for Clinical Trials (1x1 tDCS-CT).
Excitatory stimulation to the left hemisphere will be achieved through a 1x1 montage utilizing two carbon-rubber electrodes and 5x7 EASY pad sponges (A-tDCS [excitatory]left target; C-tDCS [inhibitory]right hemisphere). Each PWA will have a unique 5-digit tDCS program code for each treatment phase. One code will instruct the 1x1 tDCS-CT to administer active stimulation as describe above (i.e., 1.5 mA for 20 min). The other will administer 1.5 mA for only a few seconds to simulate active stimulation. SLT will consist of Semantic Feature Analysis, Phonological Component Analysis, and Verb Network Strengthening Treatment
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation with SLT
Intervention Description
Control condition in which only SLT is administered.Participant receives 1.5 mA for only a few seconds to simulate active stimulation, then the stimulation will cease. SLT will consist of Semantic Feature Analysis, Phonological Component Analysis, and Verb Network Strengthening Treatment
Primary Outcome Measure Information:
Title
Change in correct naming of nouns on Philadelphia Naming Test.
Description
Naming gains for untreated items.
Time Frame
Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion
Secondary Outcome Measure Information:
Title
Change in correct naming of verbs on Action Naming Test
Description
Naming gains for untreated items.
Time Frame
Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of post-stroke aphasia
Single left hemisphere stroke etiology
At least 6 months post-stroke
Age range between 18 and 80 years old
Speak English as a native language
Adequate hearing and vision to complete the tasks
Exclusion Criteria:
Severe auditory comprehension deficits (determined by pretest) (i.e., global aphasia, Wernicke's aphasia, transcortical sensory aphasia)
Inability to provide informed consent
Co-occurring history of neurological disease/disorder/injury (e.g., traumatic brain injury, right hemisphere stroke, dementia)
Co-occurring history of a major mental illness (e.g., schizophrenia, drug addiction, bipolar)
Clinical conditions contraindicated for MRI or tDCS (e.g., implanted electrical devices, claustrophobia, seizure disorder)
Positive pregnancy test (for females)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Moser, PhD, CCC-SLP
Phone
501-569-8914
Email
DRMoser@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Portia Carr
Phone
501-569-3155
Email
PSCarr@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Moser, PhD, CCC-SLP
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Moser, PhD, CCC-SLP
Phone
501-603-1011
Email
DRMoser@uams.edu
First Name & Middle Initial & Last Name & Degree
Portia Carr
Phone
501-569-3155
Email
PCarr@uams.edu
First Name & Middle Initial & Last Name & Degree
Dana Moser, PhD, CCC-SLP
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment Outcomes With tDCS in Post-Stroke Aphasia
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