Aphasia
Conditions
Keywords
Aphasia, Stroke, Transcranial Direct Current Stimulation, Neuroplasticity
Brief summary
This study tests whether weak electrical stimulation of the brain is effective in improving language or reading difficulties occurring after a brain injury or stroke.
Detailed description
This study tests whether aphasia or alexia, language and reading disorders occurring after traumatic brain injury or stroke, can be improved using transcranial direct current stimulation (tDCS). tDCS is a non-invasive technique that applies a small amount of direct electrical current to the brain in order to temporarily alter brain processing. Adults with aphasia/alexia resulting from stroke or traumatic brain injury will undergo baseline behavioral testing of various language and cognitive functions. Subjects who are willing to undergo MRI evaluation will also be scanned. They will then receive five days of either real or sham tDCS with standardized speech-language therapy, under a double-blind randomized placebo-controlled design. Behavioral assessments, and MRIs for those participating in the MRI portion of the study, will be performed again at multiple time points after completing tDCS to assess for changes in these measures.
Interventions
DEVICETranscranial Direct Current Stimulation
The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
DEVICESham Stimulation
The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
Sponsors
Medstar Health Research Institute
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Aphasia due to left hemisphere stroke diagnosed by a physician or speech-language pathologist
Exclusion criteria
* Skull defect at or near the site of tDCS delivery * History of a significant stroke or traumatic brain injury other than the event that caused the aphasia * History of other brain conditions that could impact interpretation of results (such as multiple sclerosis, brain tumor, encephalitis, premorbid dementia) * Presence of implanted electrical or metallic devices in the head or body (except titanium; e.g. cochlear implants, implanted shunts with metal parts, deep brain stimulators, pacemakers, defibrillators) * Presence of ferrous metal in the head (e.g. shrapnel) * History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common selective serotonin reuptake inhibitor antidepressants) * Pregnancy * Severe comprehension deficits Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Aphasia Battery - Revised: Naming and Word Finding Score | Change from baseline to one day after treatment | This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Philadelphia Naming Test (PNT) | 1 day after treatment | A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly. |
| Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | 3 weeks post-treatment | Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with as able as before the stroke written on the right side of the line and not at all as able on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates as able as before the stroke and 0 indicates not at all as able. |
| Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Change from baseline to 1 day after treatment | The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present). |
| Reading Assessments | Change from baseline to 1 day after treatment | A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly. |
| Motricity Index | Change from baseline to 1 day after treatment | An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested. |
| Cognitive-Linguistic Quick Test (CLQT) | Change from baseline to 1 day after treatment | The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0 |
Countries
United States
Participant flow
Recruitment details
Inclusionary criteria were as follows: over 18; aphasia due to left hemisphere stroke; no other significant brain damage, neurological, or psychiatric disease; no skull defects near electrode sites; no implanted devices or ferrous metal in the body; not pregnant; comprehension sufficient to perform study tasks
Pre-assignment details
Before randomization, potential subjects were tested on the Western Aphasia Battery -Revised (WAB-R) to determine a baseline score and to rule out severe comprehension deficits.
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Direct Current Stimulation Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period. | 24 |
| Sham Stimulation Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period. | 14 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Transcranial Direct Current Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 10.8 | 59.8 years STANDARD_DEVIATION 8.7 | 60.0 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 24 participants | 14 participants | 38 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 16 Participants | 9 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 14 |
| serious Total, serious adverse events | 0 / 24 | 0 / 14 |
Outcome results
Primary
Western Aphasia Battery - Revised: Naming and Word Finding Score
This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.
Time frame: Change from baseline to one day after treatment
Population: People with aphasia due to left hemisphere stroke
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Western Aphasia Battery - Revised: Naming and Word Finding Score | .30 scores on a scale | Standard Deviation 0.64 |
| Sham Stimulation | Western Aphasia Battery - Revised: Naming and Word Finding Score | .48 scores on a scale | Standard Deviation 0.74 |
p-value: 0.57Mixed Models Analysis
Secondary
Cognitive-Linguistic Quick Test (CLQT)
The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0
Time frame: Change from baseline to 1 day after treatment
Population: People with aphasia due to left hemisphere stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Attention Composite Score Baseline | 150.0 scores on a scale | Standard Deviation 46.4 |
| Transcranial Direct Current Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Attention Composite Score 1 day post-treatment | 155.9 scores on a scale | Standard Deviation 50.3 |
| Transcranial Direct Current Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Executive Function Composite Score Baseline | 21.9 scores on a scale | Standard Deviation 6.5 |
| Transcranial Direct Current Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Executive Function Composite Score 1 Day Post | 23.1 scores on a scale | Standard Deviation 7.6 |
| Transcranial Direct Current Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Visuospatial Function Composite Score Baseline | 78.6 scores on a scale | Standard Deviation 17.6 |
| Transcranial Direct Current Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Visuospatial Function Composite Score 1 Day Post | 80.7 scores on a scale | Standard Deviation 20.4 |
| Sham Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Visuospatial Function Composite Score Baseline | 86.7 scores on a scale | Standard Deviation 12.9 |
| Sham Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Attention Composite Score Baseline | 175.5 scores on a scale | Standard Deviation 33.1 |
| Sham Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Executive Function Composite Score 1 Day Post | 25.3 scores on a scale | Standard Deviation 5.6 |
| Sham Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Attention Composite Score 1 day post-treatment | 184.9 scores on a scale | Standard Deviation 21.2 |
| Sham Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Visuospatial Function Composite Score 1 Day Post | 91.4 scores on a scale | Standard Deviation 12.6 |
| Sham Stimulation | Cognitive-Linguistic Quick Test (CLQT) | Executive Function Composite Score Baseline | 23.7 scores on a scale | Standard Deviation 5.8 |
Secondary
Motricity Index
An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.
Time frame: Change from baseline to 1 day after treatment
Population: People with aphasia due to left hemisphere stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Motricity Index | Elbow Flexion Left 1 Day Post-treatment | 33 scores on a scale | Standard Deviation 0 |
| Transcranial Direct Current Stimulation | Motricity Index | Elbow Flexion Right 1 Day Post-treatment | 24.0 scores on a scale | Standard Deviation 11.7 |
| Transcranial Direct Current Stimulation | Motricity Index | Shoulder Abduction Left 1 Day Post-treatment | 33 scores on a scale | Standard Deviation 0 |
| Transcranial Direct Current Stimulation | Motricity Index | Shoulder Abduction Right Baseline | 22.9 scores on a scale | Standard Deviation 11.7 |
| Transcranial Direct Current Stimulation | Motricity Index | Pinch Grip Right Baseline | 25.9 scores on a scale | Standard Deviation 10.2 |
| Transcranial Direct Current Stimulation | Motricity Index | Shoulder Abduction Left Baseline | 32.6 scores on a scale | Standard Deviation 1.7 |
| Transcranial Direct Current Stimulation | Motricity Index | Pinch Grip Right 1 Day Post-treatment | 25.9 scores on a scale | Standard Deviation 10.3 |
| Transcranial Direct Current Stimulation | Motricity Index | Pinch Grip Left Baseline | 33 scores on a scale | Standard Deviation 0 |
| Transcranial Direct Current Stimulation | Motricity Index | Elbow Flexion Right Baseline | 22.4 scores on a scale | Standard Deviation 12.2 |
| Transcranial Direct Current Stimulation | Motricity Index | Pinch Grip Left 1 Day Post-treatment | 33 scores on a scale | Standard Deviation 0 |
| Transcranial Direct Current Stimulation | Motricity Index | Shoulder Abduction Right 1 Day Post-treatment | 21.7 scores on a scale | Standard Deviation 12.7 |
| Transcranial Direct Current Stimulation | Motricity Index | Elbow Flexion Left Baseline | 33 scores on a scale | Standard Deviation 0 |
| Sham Stimulation | Motricity Index | Shoulder Abduction Right 1 Day Post-treatment | 17.4 scores on a scale | Standard Deviation 14.9 |
| Sham Stimulation | Motricity Index | Elbow Flexion Left Baseline | 33 scores on a scale | Standard Deviation 0 |
| Sham Stimulation | Motricity Index | Elbow Flexion Left 1 Day Post-treatment | 33 scores on a scale | Standard Deviation 0 |
| Sham Stimulation | Motricity Index | Elbow Flexion Right Baseline | 19.0 scores on a scale | Standard Deviation 14.9 |
| Sham Stimulation | Motricity Index | Shoulder Abduction Right Baseline | 17.0 scores on a scale | Standard Deviation 15 |
| Sham Stimulation | Motricity Index | Pinch Grip Left 1 Day Post-treatment | 33 scores on a scale | Standard Deviation 0 |
| Sham Stimulation | Motricity Index | Shoulder Abduction Left Baseline | 33 scores on a scale | Standard Deviation 0 |
| Sham Stimulation | Motricity Index | Shoulder Abduction Left 1 Day Post-treatment | 33 scores on a scale | Standard Deviation 0 |
| Sham Stimulation | Motricity Index | Pinch Grip Right Baseline | 19.1 scores on a scale | Standard Deviation 15.9 |
| Sham Stimulation | Motricity Index | Pinch Grip Right 1 Day Post-treatment | 18.4 scores on a scale | Standard Deviation 16.6 |
| Sham Stimulation | Motricity Index | Elbow Flexion Right 1 Day Post-treatment | 19.0 scores on a scale | Standard Deviation 14.9 |
| Sham Stimulation | Motricity Index | Pinch Grip Left Baseline | 33 scores on a scale | Standard Deviation 0 |
Secondary
Philadelphia Naming Test (PNT)
A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.
Time frame: 1 day after treatment
Population: People with aphasia due to left hemisphere stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Philadelphia Naming Test (PNT) | PNT Score 1 Day Post-treatment | 34.1 scores on a scale | Standard Deviation 21.1 |
| Transcranial Direct Current Stimulation | Philadelphia Naming Test (PNT) | PNT Score Baseline | 31.3 scores on a scale | Standard Deviation 17.8 |
| Sham Stimulation | Philadelphia Naming Test (PNT) | PNT Score 1 Day Post-treatment | 34.9 scores on a scale | Standard Deviation 3.1 |
| Sham Stimulation | Philadelphia Naming Test (PNT) | PNT Score Baseline | 32.1 scores on a scale | Standard Deviation 23.5 |
p-value: 0.64Mixed Models Analysis
Secondary
Reading Assessments
A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.
Time frame: Change from baseline to 1 day after treatment
Population: People with aphasia due to left hemisphere stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Reading Assessments | Reading Non-words 1 Day Post-treatment | 6.3 scores on a scale | Standard Deviation 7.4 |
| Transcranial Direct Current Stimulation | Reading Assessments | Reading Real Words Baseline | 89.1 scores on a scale | Standard Deviation 51.2 |
| Transcranial Direct Current Stimulation | Reading Assessments | Reading Real Words 1 Day Post-treatment | 89.7 scores on a scale | Standard Deviation 50.5 |
| Transcranial Direct Current Stimulation | Reading Assessments | Reading Non-words Baseline | 6.1 scores on a scale | Standard Deviation 6.3 |
| Sham Stimulation | Reading Assessments | Reading Non-words Baseline | 8.9 scores on a scale | Standard Deviation 8.8 |
| Sham Stimulation | Reading Assessments | Reading Non-words 1 Day Post-treatment | 8.5 scores on a scale | Standard Deviation 8 |
| Sham Stimulation | Reading Assessments | Reading Real Words 1 Day Post-treatment | 87.3 scores on a scale | Standard Deviation 59.2 |
| Sham Stimulation | Reading Assessments | Reading Real Words Baseline | 85.1 scores on a scale | Standard Deviation 61.7 |
Secondary
Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)
Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with as able as before the stroke written on the right side of the line and not at all as able on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates as able as before the stroke and 0 indicates not at all as able.
Time frame: 3 weeks post-treatment
Population: People with aphasia due to left hemisphere stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | SADQ Baseline | 1.2 scores on a scale | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | SADQ 3 weeks post-treatment | 1.0 scores on a scale | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | SAQOL Baseline | 2.7 scores on a scale | Standard Deviation 0.7 |
| Transcranial Direct Current Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | SAQOL 3 weeks post-treatment | 2.9 scores on a scale | Standard Deviation 0.8 |
| Transcranial Direct Current Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | CETI Baseline | 5.7 scores on a scale | Standard Deviation 1.7 |
| Transcranial Direct Current Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | CETI 3 weeks post-treatment | 6.6 scores on a scale | Standard Deviation 2 |
| Sham Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | CETI Baseline | 6.8 scores on a scale | Standard Deviation 1.9 |
| Sham Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | SADQ Baseline | 1.58 scores on a scale | Standard Deviation 0.4 |
| Sham Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | SAQOL 3 weeks post-treatment | 2.7 scores on a scale | Standard Deviation 0.9 |
| Sham Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | SADQ 3 weeks post-treatment | 1.3 scores on a scale | Standard Deviation 0.4 |
| Sham Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | CETI 3 weeks post-treatment | 6.4 scores on a scale | Standard Deviation 1.9 |
| Sham Stimulation | Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ) | SAQOL Baseline | 2.6 scores on a scale | Standard Deviation 0.7 |
Secondary
Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient
The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).
Time frame: Change from baseline to 1 day after treatment
Population: People with aphasia due to left hemisphere stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Spontaneous Speech Baseline | 7.6 scores on a scale | Standard Deviation 2 |
| Transcranial Direct Current Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Auditory Verbal Comprehension Baseline | 7.9 scores on a scale | Standard Deviation 1.3 |
| Transcranial Direct Current Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Repetition Baseline | 5.5 scores on a scale | Standard Deviation 2.9 |
| Transcranial Direct Current Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Auditory Verbal Comprehension 1 day post | 8.1 scores on a scale | Standard Deviation 1.4 |
| Transcranial Direct Current Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Spontaneous Speech 1 day post-treatment | 7.8 scores on a scale | Standard Deviation 2.4 |
| Transcranial Direct Current Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Aphasia Quotient Baseline | 66.2 scores on a scale | Standard Deviation 21.7 |
| Transcranial Direct Current Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Repetition 1 Day post-treatment | 5.8 scores on a scale | Standard Deviation 2.8 |
| Transcranial Direct Current Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Aphasia Quotient 1 Day post-treatment | 66.2 scores on a scale | Standard Deviation 21.7 |
| Sham Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Repetition 1 Day post-treatment | 6.2 scores on a scale | Standard Deviation 3.1 |
| Sham Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Spontaneous Speech Baseline | 7.1 scores on a scale | Standard Deviation 2.8 |
| Sham Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Spontaneous Speech 1 day post-treatment | 7.0 scores on a scale | Standard Deviation 2.9 |
| Sham Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Repetition Baseline | 6.2 scores on a scale | Standard Deviation 2.9 |
| Sham Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Aphasia Quotient 1 Day post-treatment | 65.1 scores on a scale | Standard Deviation 26.7 |
| Sham Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Auditory Verbal Comprehension Baseline | 8.0 scores on a scale | Standard Deviation 1.9 |
| Sham Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Auditory Verbal Comprehension 1 day post | 7.8 scores on a scale | Standard Deviation 1.9 |
| Sham Stimulation | Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient | Aphasia Quotient Baseline | 61.9 scores on a scale | Standard Deviation 28.6 |