Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Outcomes With tDCS in Post-Stroke Aphasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03929432
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Intervention/treatment Phase
Aphasia Device: Active Transcranial Direct Current Stimulation with SLT Device: Sham Transcranial Direct Current Stimulation with SLT Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929432


Contacts
Layout table for location contacts
Contact: Dana Moser, PhD, CCC-SLP 501-569-8914 DRMoser@uams.edu
Contact: Portia Carr 501-569-3155 PSCarr@uams.edu

Locations
Layout table for location information
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         
Sponsors and Collaborators
University of Arkansas
Investigators
Layout table for investigator information
Principal Investigator: Dana Moser, PhD, CCC-SLP University of Arkansas
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03929432    
Other Study ID Numbers: 207342
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases