Aphasia, Stroke
Conditions
Keywords
tDCS, treatment, brain stimulation
Brief summary
This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.
Detailed description
Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS). This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy. Study design: Patients will be randomly assigned to one of 2 speech therapy groups in a double-blind, partial crossover design. Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted or active-control anodal-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to either receive the tDCS intervention they did not already receive, within the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.
Interventions
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the targeted region.
DEVICEActive Control Transcranial Direct Current Stimulation
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the active control region.
BEHAVIORALPhonologic-Focused Speech Therapy
Participants are asked to generate or choose from a list phonologic information about a target picture.
BEHAVIORALSemantic-Focused Speech Therapy
Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Care provider, participant, and outcome assessor are masked for tDCS status.
Intervention model description
Partial crossover design. Participants will maintain one of two speech therapy modalities throughout the study, but will crossover from targeted to active control stimulation (or vice versa).
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a language deficit from focal neurologic damage (e.g. stroke, tumor). * Patients must be adults and have English-language fluency. * Patients must be eligible to undergo MRI.
Exclusion criteria
* Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease) or neurologic disorder (e.g. idiopathic epilepsy, Parkinson's disease, ALS) * Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode) * No suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability). * Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, and inability to see or hear stimulus materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post | Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct). There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs. Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A. Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fMRI After Cycle A | 10-weeks post Cycle A | Number of participants completing Rs-fMRI after Cycle A therapy. |
| fMRI Post Cycle B | 10 weeks post cycle B | Number of participants completing fMRI post Cycle B |
| fMRI- Baseline | Baseline | Number of participants completing Rs-fMRI before therapy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Performance on Outcome Measures Assessed Through the Language Battery | 3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B | A language battery screen assessing different language processes and providing an overall severity score (Quick Aphasia Battery or QAB) will be repeated three times (Time 1, Time 2, Time 3). Also outcomes on self-reported measures assessing confidence with speaking: Communicative Effectiveness Index (CETI), Communication Confidence Rating Scale for Aphasia (CCRSA) and overall symptoms of depression; Center for Epidemiologic Studies Short Depression Scale (CES-D-10). QAB = Total score range 0-10, higher scores mean less severe aphasia severity CETI= Total score range 1-100, higher scores mean better perceived communication confidence by an outside rater CCRSA = Total score range 0-100, higher scores mean more confidence in speaking ability CES-D-10= Total score range 0-30, scores \>10 indicate symptoms of depression |
Countries
United States
Participant flow
Recruitment details
Recruitment took place from August 5, 2019 through April 30, 2024 at a medical clinic and from an aphasia databank. The first participant was enrolled on December 13, 2019, and the last participant was enrolled August 11, 2023.
Pre-assignment details
After enrollment, participants underwent screening tests to ensure behavioral criteria was met. Of the 25 enrollments, 19 met behavioral criteria and were randomized into an arm. Those who did not meet behavioral criteria did not continue in the study.
Participants by arm
| Arm | Count |
|---|---|
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS Phonologic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS.
Participants receive phonologic speech therapy for both cycles of speech therapy. They receive targeted tDCS first, then active control tDCS second.
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. | 5 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS Phonologic-Focused Speech Therapy - Active Control tDCS first, then Targeted tDCS
Participants receive phonologic speech therapy for both cycles of speech therapy. They receive active control tDCS first, then targeted tDCS second.
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. | 5 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Participants receive semantic speech therapy for both cycles of speech therapy. They receive targeted tDCS first, then active control tDCS second.
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. | 4 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Participants receive semantic speech therapy for both cycles of speech therapy. They receive active control tDCS first, then targeted tDCS second.
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. | 5 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Behavioral Assessment 1 | Investigator Withdrawn | 0 | 0 | 0 | 1 |
| Behavioral Assessment 1 | Withdrawal by Subject | 0 | 1 | 0 | 0 |
| Behavioral Assessment 4 | Lost to Follow-up | 1 | 0 | 1 | 1 |
| Behavioral Assessment 4 | Withdrawal by Subject | 2 | 2 | 1 | 0 |
| Therapy Cycle B | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 16 Participants |
| Age, Continuous | 47.8 years | 50.8 years | 47.75 years | 59.8 years | 51.54 years |
| Days Past Stroke Onset | 1525 days | 1697 days | 1260 days | 1262 days | 1436 days |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 4 Participants | 5 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 2 Participants | 4 Participants | 12 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 4 participants | 5 participants | 19 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 10 Participants |
| Years of Education | 15.2 years | 17 years | 14.5 years | 13.2 years | 14.9 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 1 / 8 | 0 / 8 | 3 / 8 | 2 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 7 |
Outcome results
Primary
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct). There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs. Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A. Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A.
Time frame: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
Population: Cycle B participant analyzed is less than overall number to reflect participants who dropped out of the study part-way through
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBTrainWord | 51 percentage of items correct | Standard Deviation 34 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBTrainWord | 66 percentage of items correct | Standard Deviation 31 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleAUntrainWord | 18 percentage of items correct | Standard Deviation 21 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBTrainPic | 43 percentage of items correct | Standard Deviation 37 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBUntrainPic | 24 percentage of items correct | Standard Deviation 21 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleATrainPics | 49 percentage of items correct | Standard Deviation 47 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBUntrainWord | 24 percentage of items correct | Standard Deviation 19 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleATrainWord | 47 percentage of items correct | Standard Deviation 43 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntrainPic | 27 percentage of items correct | Standard Deviation 17 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleATrainPic | 39 percentage of items correct | Standard Deviation 34 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleATrainWord | 36 percentage of items correct | Standard Deviation 29 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntestWord | 19 percentage of items correct | Standard Deviation 19 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntestPics | 18 percentage of items correct | Standard Deviation 15 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntrainWord | 23 percentage of items correct | Standard Deviation 18 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntestWord | 22 percentage of items correct | Standard Deviation 19 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleAUntrainPic | 17 percentage of items correct | Standard Deviation 24 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntestPic | 21 percentage of items correct | Standard Deviation 20 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntrainPic | 21 percentage of items correct | Standard Deviation 18 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntrainWord | 21 percentage of items correct | Standard Deviation 15 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBTrainPic | 65 percentage of items correct | Standard Deviation 46 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBTrainWord | 40 percentage of items correct | Standard Deviation 24 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBTrainPic | 64 percentage of items correct | Standard Deviation 22 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntrainPic | 24 percentage of items correct | Standard Deviation 15 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBTrainPic | 21 percentage of items correct | Standard Deviation 17 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleATrainWord | 45 percentage of items correct | Standard Deviation 5 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBTrainWord | 65 percentage of items correct | Standard Deviation 26 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleATrainPics | 72 percentage of items correct | Standard Deviation 3 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntrainWord | 28 percentage of items correct | Standard Deviation 18 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntrainWord | 33 percentage of items correct | Standard Deviation 18 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBUntrainPic | 19 percentage of items correct | Standard Deviation 21 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntestPics | 33 percentage of items correct | Standard Deviation 25 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBUntrainWord | 24 percentage of items correct | Standard Deviation 19 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntrainPic | 23 percentage of items correct | Standard Deviation 20 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleAUntrainWord | 35 percentage of items correct | Standard Deviation 13 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntestPic | 19 percentage of items correct | Standard Deviation 6 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleAUntrainPic | 30 percentage of items correct | Standard Deviation 15 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntestWord | 27 percentage of items correct | Standard Deviation 20 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleATrainPic | 48 percentage of items correct | Standard Deviation 19 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleATrainWord | 65 percentage of items correct | Standard Deviation 5 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntestWord | 16 percentage of items correct | Standard Deviation 11 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBUntrainPic | 28 percentage of items correct | Standard Deviation 32 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleATrainPics | 56 percentage of items correct | Standard Deviation 43 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleATrainWord | 50 percentage of items correct | Standard Deviation 13 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleAUntrainPic | 25 percentage of items correct | Standard Deviation 24 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleAUntrainWord | 27 percentage of items correct | Standard Deviation 15 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleATrainPic | 44 percentage of items correct | Standard Deviation 32 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleATrainWord | 33 percentage of items correct | Standard Deviation 13 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntestPics | 38 percentage of items correct | Standard Deviation 29 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntestWord | 36 percentage of items correct | Standard Deviation 25 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntrainPic | 35 percentage of items correct | Standard Deviation 13 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntrainWord | 30 percentage of items correct | Standard Deviation 14 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBTrainPic | 42 percentage of items correct | Standard Deviation 35 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBTrainWord | 47 percentage of items correct | Standard Deviation 33 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBUntrainWord | 32 percentage of items correct | Standard Deviation 10 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBTrainPic | 30 percentage of items correct | Standard Deviation 26 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBTrainWord | 27 percentage of items correct | Standard Deviation 14 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntestPic | 20 percentage of items correct | Standard Deviation 26 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntestWord | 28 percentage of items correct | Standard Deviation 20 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntrainPic | 28 percentage of items correct | Standard Deviation 24 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntrainWord | 35 percentage of items correct | Standard Deviation 13 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntrainWord | 32 percentage of items correct | Standard Deviation 29 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntrainPic | 18 percentage of items correct | Standard Deviation 6 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntrainPic | 29 percentage of items correct | Standard Deviation 20 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBTrainWord | 37 percentage of items correct | Standard Deviation 28 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntestWord | 55 percentage of items correct | Standard Deviation 21 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleAUntestPics | 13 percentage of items correct | Standard Deviation 18 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleATrainWord | 42 percentage of items correct | Standard Deviation 39 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntestPic | 30 percentage of items correct | Standard Deviation 13 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleATrainWord | 45 percentage of items correct | Standard Deviation 35 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleATrainPic | 30 percentage of items correct | Standard Deviation 18 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleATrainPics | 56 percentage of items correct | Standard Deviation 30 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntestWord | 32 percentage of items correct | Standard Deviation 43 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleAUntrainWord | 27 percentage of items correct | Standard Deviation 29 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBUntrainPic | 19 percentage of items correct | Standard Deviation 16 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleAUntrainPic | 10 percentage of items correct | Standard Deviation 11 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBUntrainWord | 38 percentage of items correct | Standard Deviation 45 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBTrainWord | 57 percentage of items correct | Standard Deviation 29 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | CycleBTrainPic | 57 percentage of items correct | Standard Deviation 36 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBUntrainWord | 38 percentage of items correct | Standard Deviation 42 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | PostCycleBTrainPic | 33 percentage of items correct | Standard Deviation 20 |
Secondary
fMRI After Cycle A
Number of participants completing Rs-fMRI after Cycle A therapy.
Time frame: 10-weeks post Cycle A
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | fMRI After Cycle A | 5 Participants |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | fMRI After Cycle A | 4 Participants |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | fMRI After Cycle A | 4 Participants |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | fMRI After Cycle A | 4 Participants |
Secondary
fMRI- Baseline
Number of participants completing Rs-fMRI before therapy.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | fMRI- Baseline | 5 Participants |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | fMRI- Baseline | 5 Participants |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | fMRI- Baseline | 4 Participants |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | fMRI- Baseline | 5 Participants |
Secondary
fMRI Post Cycle B
Number of participants completing fMRI post Cycle B
Time frame: 10 weeks post cycle B
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | fMRI Post Cycle B | 4 Participants |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | fMRI Post Cycle B | 3 Participants |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | fMRI Post Cycle B | 3 Participants |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | fMRI Post Cycle B | 4 Participants |
Other Pre-specified
Performance on Outcome Measures Assessed Through the Language Battery
A language battery screen assessing different language processes and providing an overall severity score (Quick Aphasia Battery or QAB) will be repeated three times (Time 1, Time 2, Time 3). Also outcomes on self-reported measures assessing confidence with speaking: Communicative Effectiveness Index (CETI), Communication Confidence Rating Scale for Aphasia (CCRSA) and overall symptoms of depression; Center for Epidemiologic Studies Short Depression Scale (CES-D-10). QAB = Total score range 0-10, higher scores mean less severe aphasia severity CETI= Total score range 1-100, higher scores mean better perceived communication confidence by an outside rater CCRSA = Total score range 0-100, higher scores mean more confidence in speaking ability CES-D-10= Total score range 0-30, scores \>10 indicate symptoms of depression
Time frame: 3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B
Population: Number below analyzed is different from overall number analyzed due to participants dropping out of study or self-report forms incomplete.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T1 | 13 score on a scale | Standard Deviation 8 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T3 | 8 score on a scale | Standard Deviation 4 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T2 | 51 score on a scale | Standard Deviation 24 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T1 | 6 score on a scale | Standard Deviation 3 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T3 | 61 score on a scale | Standard Deviation 20 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T3 | 6 score on a scale | Standard Deviation 3 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T1 | 66 score on a scale | Standard Deviation 38 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T2 | 5 score on a scale | Standard Deviation 4 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T2 | 8 score on a scale | Standard Deviation 4 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T2 | 82 score on a scale | Standard Deviation 61 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T3 | 85 score on a scale | Standard Deviation 60 |
| Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T1 | 50 score on a scale | Standard Deviation 20 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T2 | 7 score on a scale | Standard Deviation 1 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T1 | 68 score on a scale | Standard Deviation 29 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T1 | 100 score on a scale | Standard Deviation 32 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T3 | 78 score on a scale | Standard Deviation 9 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T1 | 7 score on a scale | Standard Deviation 8 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T2 | 77 score on a scale | Standard Deviation 17 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T1 | 6 score on a scale | Standard Deviation 1 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T3 | 117 score on a scale | Standard Deviation 15 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T2 | 122 score on a scale | Standard Deviation 13 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T3 | 7 score on a scale | Standard Deviation 1 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T3 | 8 score on a scale | Standard Deviation 7 |
| Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T2 | 5 score on a scale | Standard Deviation 6 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T2 | 66 score on a scale | Standard Deviation 22 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T1 | 7 score on a scale | Standard Deviation 2 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T2 | 7 score on a scale | Standard Deviation 2 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T3 | 6 score on a scale | Standard Deviation 0 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T1 | 78 score on a scale | Standard Deviation 28 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T2 | 81 score on a scale | Standard Deviation 27 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T3 | 83 score on a scale | Standard Deviation 17 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T1 | 56 score on a scale | Standard Deviation 23 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T3 | 71 score on a scale | Standard Deviation 10 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T1 | 13 score on a scale | Standard Deviation 13 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T2 | 8 score on a scale | Standard Deviation 6 |
| Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T3 | 6 score on a scale | Standard Deviation 4 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T3 | 108 score on a scale | Standard Deviation 21 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T2 | 104 score on a scale | Standard Deviation 30 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T1 | 7 score on a scale | Standard Deviation 2 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T1 | 4 score on a scale | Standard Deviation 5 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CETI T1 | 102 score on a scale | Standard Deviation 37 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T3 | 7 score on a scale | Standard Deviation 3 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T3 | 5 score on a scale | Standard Deviation 9 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CESD T2 | 8 score on a scale | Standard Deviation 7 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T2 | 63 score on a scale | Standard Deviation 15 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T1 | 66 score on a scale | Standard Deviation 26 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | QAB total T2 | 7 score on a scale | Standard Deviation 2 |
| Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Performance on Outcome Measures Assessed Through the Language Battery | CCRSA T3 | 71 score on a scale | Standard Deviation 11 |