Aphasia, Broca's Aphasia
Conditions
Keywords
tDCS, STARS, Aphasia, Stroke
Brief summary
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.
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.
Interventions
DEVICEtDCS
The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).
Sponsors
University of South Carolina
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Phase II: 1 mA, 2 mA, sham; Phase III: best mA dose, sham
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Naming | From baseline assessment to 4-weeks post treatment | Change in the number of correctly named items between the average of the two pre-treatment Philadelphia Naming Test (PNT) assessments and the average of the two post-treatment PNT sessions at 4-weeks post treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Naming | From baseline assessment to 1-week post treatment | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 1-week post treatment. |
| Aphasia Severity | From baseline assessment to 4-weeks post treatment | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in reducing aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ). |
| Functional Communication | From baseline assessment to 4-weeks post treatment | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving functional communication. |
| Quality of Life | From baseline assessment to 4-weeks post treatment | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving quality of life as measured by the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39). |
| Communication Confidence | From baseline assessment to 4-weeks post treatment | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving communication confidence. |
| Safety | From baseline assessment to 4-weeks post treatment | To demonstrate safety differences (proportion of new adverse events) between groups. |
Countries
United States
Contacts
CONTACTLeonardo Bonilha
CONTACTJulius Fridriksson
Outcome results
None listed