Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation
Purpose
The purpose of this study is to help us understand if adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.
Conditions
- Aphasia
- Broca's Aphasia
Eligibility
- Eligible Ages
- Between 25 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Be willing and able to give informed consent. - Be willing and able to comply with study requirements. - Be between 25 and 80 years of age. - Have used English as the primary language for > 15 years. - Have the diagnosis of aphasia due to a left hemisphere stroke, confirmed by study physician based on past clinical MRI scan or research scan. - Be greater than 6 months post-stroke. - Have Broca's aphasia diagnosed by the WAB-R (fluency score ≤ 5, auditory verbal comprehension score 4-10, repetition score 0-7.9, naming and word finding score < 9). - Correctly name 140 or fewer items on the PNT.
Exclusion Criteria
- History of brain surgery except for during the treatment of the acute stroke. - Seizures during the previous 12-months. - Compromised skin at or near electrode sites (e.g., rash, eczema, wounds, infection). - Correctly name more than 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test). - Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) score of 25 or below. - Participants with open skull defects (e.g., greater than 1 cm) in the area underneath the anode electrode positioning or participants with metal implants or electrical stimulators. - Participants with continuous oxygen therapy which cannot be discontinued for more than 1 hour. - Any condition or situation that the PI determines would significantly interfere with the participant's ability to complete the study.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Phase II: 1 mA, 2 mA, sham; Phase III: best mA dose, sham
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 1 mA A-tDCS |
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Active Comparator 2 mA A-tDCS |
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Sham Comparator S-tDCS |
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Recruiting Locations
Charleston, South Carolina 29425
Columbia, South Carolina 29201
More Details
- Status
- Recruiting
- Sponsor
- University of South Carolina
Detailed Description
This project is a prospective randomized controlled double-blinded clinical trial to compare auditory-visual speech therapy coupled with adjuvant active anodal tDCS (A-tDCS) versus speech therapy coupled with sham tDCS (S-tDCS). The investigators will perform an adaptive Phase II/III design, in which the first portion of the study (Phase II) will determine the optimal dose of A-tDCS (1 mA versus 2 mA) and provide a go/no-go decision for Phase III. The investigators will use a 10-10 system to determine electrode placement, with 5 x 5 cm pads, and stimulation duration will be 20 minutes. Phase III will test the definitive superiority of adjuvant A-tDCS at the optimal dose coupled with speech therapy versus speech therapy alone (S-tDCS) to improve naming among individuals with chronic Broca's aphasia.