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Treatment Outcomes With tDCS in Post-Stroke Aphasia
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aphasia | Device: Active Transcranial Direct Current Stimulation with SLT Device: Sham Transcranial Direct Current Stimulation with SLT | Not Applicable |
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)
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Active tDCS versus sham tDCS will be masked to the participants |
| Primary Purpose: | Treatment |
| Official Title: | Treatment Outcomes and Brain Mechanisms Associated With Non-Invasive Neuromodulation in Post-Stroke Aphasia |
| Actual Study Start Date : | September 3, 2019 |
| Estimated Primary Completion Date : | August 2022 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Active tDCS (with Speech-Language Treatment)
tDCS Stimulation Dose: 1.5 mA for 20-mins
|
Device: Active Transcranial Direct Current Stimulation with SLT
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 |
|
Sham Comparator: Sham tDCS (with Speech-Language Treatment)
No tDCS stimulation
|
Device: Sham Transcranial Direct Current Stimulation with SLT
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
|
- Change in correct naming of nouns on Philadelphia Naming Test. [ Time Frame: Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion ]Naming gains for untreated items.
- Change in correct naming of verbs on Action Naming Test [ Time Frame: Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion ]Naming gains for untreated items.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
| Contact: Dana Moser, PhD, CCC-SLP | 501-569-8914 | DRMoser@uams.edu | |
| Contact: Portia Carr | 501-569-3155 | PSCarr@uams.edu |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Dana Moser, PhD, CCC-SLP 501-603-1011 DRMoser@uams.edu | |
| Contact: Portia Carr 501-569-3155 PCarr@uams.edu | |
| Principal Investigator: Dana Moser, PhD, CCC-SLP | |
| Principal Investigator: | Dana Moser, PhD, CCC-SLP | University of Arkansas |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 15, 2019 | ||||||||
| First Posted Date ICMJE | April 26, 2019 | ||||||||
| Last Update Posted Date | June 7, 2021 | ||||||||
| Actual Study Start Date ICMJE | September 3, 2019 | ||||||||
| Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in correct naming of nouns on Philadelphia Naming Test. [ Time Frame: Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion ] Naming gains for untreated items.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
Change in correct naming of verbs on Action Naming Test [ Time Frame: Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion ] Naming gains for untreated items.
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treatment Outcomes With tDCS in Post-Stroke Aphasia | ||||||||
| Official Title ICMJE | Treatment Outcomes and Brain Mechanisms Associated With Non-Invasive Neuromodulation in Post-Stroke Aphasia | ||||||||
| 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) |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Active tDCS versus sham tDCS will be masked to the participants Primary Purpose: Treatment
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| Condition ICMJE | Aphasia | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
50 | ||||||||
| Original Estimated Enrollment ICMJE |
20 | ||||||||
| Estimated Study Completion Date ICMJE | December 2022 | ||||||||
| Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03929432 | ||||||||
| Other Study ID Numbers ICMJE | 207342 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | University of Arkansas | ||||||||
| Study Sponsor ICMJE | University of Arkansas | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Arkansas | ||||||||
| Verification Date | June 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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