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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Treatment Outcomes With tDCS in Post-Stroke Aphasia

Clinicaltrials.gov identifier NCT03929432

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted October 11, 2019

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.

  • Condition or Disease:Aphasia
  • Intervention/Treatment: Device: Active Transcranial Direct Current Stimulation with SLT
    Device: Sham Transcranial Direct Current Stimulation with SLT
  • Phase: N/A
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)

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Treatment Outcomes and Brain Mechanisms Associated With Non-Invasive Neuromodulation in Post-Stroke Aphasia
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: June 2021
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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)

Contacts and Locations
Contacts

Contact: Dana Moser, PhD, CCC-SLP 501-569-8914 DRMoser@uams.edu

Contact: Portia Carr 501-569-3155 PSCarr@uams.edu

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator: Dana Moser, PhD, CCC-SLP University of Arkansas

More Information
  • Responsible Party: University of Arkansas
  • ClinicalTrials.gov Identifier: NCT03929432 History of Changes
  • Other Study ID Numbers: 207342
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: October 11, 2019
  • Last Verified: October 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Additional relevant MeSH terms: Aphasia