Trial Outcomes & Findings for Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia (NCT NCT01709383)
NCT ID: NCT01709383
Last Updated: 2017-07-06
Results Overview
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.
COMPLETED
NA
38 participants
Change from baseline to one day after treatment
2017-07-06
Participant Flow
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
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
14
|
|
Overall Study
Completed Treatment
|
24
|
14
|
|
Overall Study
Completed Follow-ups
|
23
|
14
|
|
Overall Study
Included in Analysis
|
22
|
13
|
|
Overall Study
COMPLETED
|
23
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia
Baseline characteristics by cohort
| Measure |
Transcranial Direct Current Stimulation
n=24 Participants
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.
|
Sham Stimulation
n=14 Participants
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.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
14 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to one day after treatmentPopulation: People with aphasia due to left hemisphere stroke
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.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=22 Participants
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.
|
Sham Stimulation
n=13 Participants
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.
|
|---|---|---|
|
Western Aphasia Battery - Revised: Naming and Word Finding Score
|
.30 scores on a scale
Standard Deviation .64
|
.48 scores on a scale
Standard Deviation .74
|
SECONDARY outcome
Timeframe: Change from baseline to 1 day after treatmentPopulation: People with aphasia due to left hemisphere stroke
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).
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=23 Participants
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.
|
Sham Stimulation
n=14 Participants
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.
|
|---|---|---|
|
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 2.0
|
7.1 scores on a scale
Standard Deviation 2.8
|
|
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
|
7.0 scores on a scale
Standard Deviation 2.9
|
|
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
|
6.2 scores on a scale
Standard Deviation 2.9
|
|
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
|
6.2 scores on a scale
Standard Deviation 3.1
|
|
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
|
8.0 scores on a scale
Standard Deviation 1.9
|
|
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
|
7.8 scores on a scale
Standard Deviation 1.9
|
|
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
|
61.9 scores on a scale
Standard Deviation 28.6
|
|
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
|
65.1 scores on a scale
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: 1 day after treatmentPopulation: People with aphasia due to left hemisphere stroke
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.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=23 Participants
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.
|
Sham Stimulation
n=14 Participants
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.
|
|---|---|---|
|
Philadelphia Naming Test (PNT)
PNT Score Baseline
|
31.3 scores on a scale
Standard Deviation 17.8
|
32.1 scores on a scale
Standard Deviation 23.5
|
|
Philadelphia Naming Test (PNT)
PNT Score 1 Day Post-treatment
|
34.1 scores on a scale
Standard Deviation 21.1
|
34.9 scores on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 3 weeks post-treatmentPopulation: People with aphasia due to left hemisphere stroke
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".
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=18 Participants
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.
|
Sham Stimulation
n=10 Participants
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.
|
|---|---|---|
|
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 .2
|
1.58 scores on a scale
Standard Deviation .4
|
|
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 .3
|
1.3 scores on a scale
Standard Deviation .4
|
|
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 .7
|
2.6 scores on a scale
Standard Deviation .7
|
|
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 .8
|
2.7 scores on a scale
Standard Deviation .9
|
|
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
|
6.8 scores on a scale
Standard Deviation 1.9
|
|
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 2.0
|
6.4 scores on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Change from baseline to 1 day after treatmentPopulation: People with aphasia due to left hemisphere stroke
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
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=23 Participants
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.
|
Sham Stimulation
n=14 Participants
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.
|
|---|---|---|
|
Cognitive-Linguistic Quick Test (CLQT)
Visuospatial Function Composite Score 1 Day Post
|
80.7 scores on a scale
Standard Deviation 20.4
|
91.4 scores on a scale
Standard Deviation 12.6
|
|
Cognitive-Linguistic Quick Test (CLQT)
Attention Composite Score Baseline
|
150.0 scores on a scale
Standard Deviation 46.4
|
175.5 scores on a scale
Standard Deviation 33.1
|
|
Cognitive-Linguistic Quick Test (CLQT)
Attention Composite Score 1 day post-treatment
|
155.9 scores on a scale
Standard Deviation 50.3
|
184.9 scores on a scale
Standard Deviation 21.2
|
|
Cognitive-Linguistic Quick Test (CLQT)
Executive Function Composite Score Baseline
|
21.9 scores on a scale
Standard Deviation 6.5
|
23.7 scores on a scale
Standard Deviation 5.8
|
|
Cognitive-Linguistic Quick Test (CLQT)
Executive Function Composite Score 1 Day Post
|
23.1 scores on a scale
Standard Deviation 7.6
|
25.3 scores on a scale
Standard Deviation 5.6
|
|
Cognitive-Linguistic Quick Test (CLQT)
Visuospatial Function Composite Score Baseline
|
78.6 scores on a scale
Standard Deviation 17.6
|
86.7 scores on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Change from baseline to 1 day after treatmentPopulation: People with aphasia due to left hemisphere stroke
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.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=23 Participants
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.
|
Sham Stimulation
n=14 Participants
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.
|
|---|---|---|
|
Reading Assessments
Reading Real Words Baseline
|
89.1 scores on a scale
Standard Deviation 51.2
|
85.1 scores on a scale
Standard Deviation 61.7
|
|
Reading Assessments
Reading Real Words 1 Day Post-treatment
|
89.7 scores on a scale
Standard Deviation 50.5
|
87.3 scores on a scale
Standard Deviation 59.2
|
|
Reading Assessments
Reading Non-words Baseline
|
6.1 scores on a scale
Standard Deviation 6.3
|
8.9 scores on a scale
Standard Deviation 8.8
|
|
Reading Assessments
Reading Non-words 1 Day Post-treatment
|
6.3 scores on a scale
Standard Deviation 7.4
|
8.5 scores on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Change from baseline to 1 day after treatmentPopulation: People with aphasia due to left hemisphere stroke
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.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=23 Participants
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.
|
Sham Stimulation
n=14 Participants
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.
|
|---|---|---|
|
Motricity Index
Elbow Flexion Right 1 Day Post-treatment
|
24.0 scores on a scale
Standard Deviation 11.7
|
19.0 scores on a scale
Standard Deviation 14.9
|
|
Motricity Index
Pinch Grip Left Baseline
|
33 scores on a scale
Standard Deviation 0
|
33 scores on a scale
Standard Deviation 0
|
|
Motricity Index
Pinch Grip Left 1 Day Post-treatment
|
33 scores on a scale
Standard Deviation 0
|
33 scores on a scale
Standard Deviation 0
|
|
Motricity Index
Elbow Flexion Left Baseline
|
33 scores on a scale
Standard Deviation 0
|
33 scores on a scale
Standard Deviation 0
|
|
Motricity Index
Elbow Flexion Left 1 Day Post-treatment
|
33 scores on a scale
Standard Deviation 0
|
33 scores on a scale
Standard Deviation 0
|
|
Motricity Index
Shoulder Abduction Left Baseline
|
32.6 scores on a scale
Standard Deviation 1.7
|
33 scores on a scale
Standard Deviation 0
|
|
Motricity Index
Shoulder Abduction Left 1 Day Post-treatment
|
33 scores on a scale
Standard Deviation 0
|
33 scores on a scale
Standard Deviation 0
|
|
Motricity Index
Pinch Grip Right Baseline
|
25.9 scores on a scale
Standard Deviation 10.2
|
19.1 scores on a scale
Standard Deviation 15.9
|
|
Motricity Index
Pinch Grip Right 1 Day Post-treatment
|
25.9 scores on a scale
Standard Deviation 10.3
|
18.4 scores on a scale
Standard Deviation 16.6
|
|
Motricity Index
Elbow Flexion Right Baseline
|
22.4 scores on a scale
Standard Deviation 12.2
|
19.0 scores on a scale
Standard Deviation 14.9
|
|
Motricity Index
Shoulder Abduction Right Baseline
|
22.9 scores on a scale
Standard Deviation 11.7
|
17.0 scores on a scale
Standard Deviation 15.0
|
|
Motricity Index
Shoulder Abduction Right 1 Day Post-treatment
|
21.7 scores on a scale
Standard Deviation 12.7
|
17.4 scores on a scale
Standard Deviation 14.9
|
Adverse Events
Transcranial Direct Current Stimulation
Sham Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth H. Lacey, PhD, Study Coordinator
Georgetown University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place