ClinicalTrials.gov
ClinicalTrials.gov Menu

Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01709383
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
Georgetown University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Aphasia
Interventions Device: Transcranial Direct Current Stimulation
Device: Sham Stimulation
Enrollment 38

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.
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation
Hide Arm/Group Description 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: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
Period Title: Overall Study
Started 24 14
Completed Treatment 24 14
Completed Follow-ups 23 14
Included in Analysis 22 13
Completed 23 14
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation Total
Hide Arm/Group Description 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: 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 of all reporting groups
Overall Number of Baseline Participants 24 14 38
Hide Baseline Analysis Population Description
People with aphasia due to left hemisphere stroke
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 14 participants 38 participants
60.0  (10.8) 59.8  (8.7) 60.0  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 14 participants 38 participants
Female
8
  33.3%
5
  35.7%
13
  34.2%
Male
16
  66.7%
9
  64.3%
25
  65.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 14 participants 38 participants
24 14 38
1.Primary Outcome
Title Western Aphasia Battery - Revised: Naming and Word Finding Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
People with aphasia due to left hemisphere stroke
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 22 13
Mean (Standard Deviation)
Unit of Measure: scores on a scale
.30  (.64) .48  (.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Direct Current Stimulation, Sham Stimulation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .57
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
People with aphasia due to left hemisphere stroke
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 23 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Spontaneous Speech Baseline 7.6  (2.0) 7.1  (2.8)
Spontaneous Speech 1 day post-treatment 7.8  (2.4) 7.0  (2.9)
Repetition Baseline 5.5  (2.9) 6.2  (2.9)
Repetition 1 Day post-treatment 5.8  (2.8) 6.2  (3.1)
Auditory Verbal Comprehension Baseline 7.9  (1.3) 8.0  (1.9)
Auditory Verbal Comprehension 1 day post 8.1  (1.4) 7.8  (1.9)
Aphasia Quotient Baseline 66.2  (21.7) 61.9  (28.6)
Aphasia Quotient 1 Day post-treatment 66.2  (21.7) 65.1  (26.7)
3.Secondary Outcome
Title Philadelphia Naming Test (PNT)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
People with aphasia due to left hemisphere stroke
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation
Hide Arm/Group Description:

TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period

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 tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

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 Number of Participants Analyzed 23 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
PNT Score Baseline 31.3  (17.8) 32.1  (23.5)
PNT Score 1 Day Post-treatment 34.1  (21.1) 34.9  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Direct Current Stimulation, Sham Stimulation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .64
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
People with aphasia due to left hemisphere stroke
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 18 10
Mean (Standard Deviation)
Unit of Measure: scores on a scale
SADQ Baseline 1.2  (.2) 1.58  (.4)
SADQ 3 weeks post-treatment 1.0  (.3) 1.3  (.4)
SAQOL Baseline 2.7  (.7) 2.6  (.7)
SAQOL 3 weeks post-treatment 2.9  (.8) 2.7  (.9)
CETI Baseline 5.7  (1.7) 6.8  (1.9)
CETI 3 weeks post-treatment 6.6  (2.0) 6.4  (1.9)
5.Secondary Outcome
Title Cognitive-Linguistic Quick Test (CLQT)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
People with aphasia due to left hemisphere stroke
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 23 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Attention Composite Score Baseline 150.0  (46.4) 175.5  (33.1)
Attention Composite Score 1 day post-treatment 155.9  (50.3) 184.9  (21.2)
Executive Function Composite Score Baseline 21.9  (6.5) 23.7  (5.8)
Executive Function Composite Score 1 Day Post 23.1  (7.6) 25.3  (5.6)
Visuospatial Function Composite Score Baseline 78.6  (17.6) 86.7  (12.9)
Visuospatial Function Composite Score 1 Day Post 80.7  (20.4) 91.4  (12.6)
6.Secondary Outcome
Title Reading Assessments
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
People with aphasia due to left hemisphere stroke
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 23 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Reading Real Words Baseline 89.1  (51.2) 85.1  (61.7)
Reading Real Words 1 Day Post-treatment 89.7  (50.5) 87.3  (59.2)
Reading Non-words Baseline 6.1  (6.3) 8.9  (8.8)
Reading Non-words 1 Day Post-treatment 6.3  (7.4) 8.5  (8.0)
7.Secondary Outcome
Title Motricity Index
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
People with aphasia due to left hemisphere stroke
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 23 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Pinch Grip Left Baseline 33  (0) 33  (0)
Pinch Grip Left 1 Day Post-treatment 33  (0) 33  (0)
Elbow Flexion Left Baseline 33  (0) 33  (0)
Elbow Flexion Left 1 Day Post-treatment 33  (0) 33  (0)
Shoulder Abduction Left Baseline 32.6  (1.7) 33  (0)
Shoulder Abduction Left 1 Day Post-treatment 33  (0) 33  (0)
Pinch Grip Right Baseline 25.9  (10.2) 19.1  (15.9)
Pinch Grip Right 1 Day Post-treatment 25.9  (10.3) 18.4  (16.6)
Elbow Flexion Right Baseline 22.4  (12.2) 19.0  (14.9)
Elbow Flexion Right 1 Day Post-treatment 24.0  (11.7) 19.0  (14.9)
Shoulder Abduction Right Baseline 22.9  (11.7) 17.0  (15.0)
Shoulder Abduction Right 1 Day Post-treatment 21.7  (12.7) 17.4  (14.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transcranial Direct Current Stimulation Sham Stimulation
Hide Arm/Group Description 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: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
All-Cause Mortality
Transcranial Direct Current Stimulation Sham Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Transcranial Direct Current Stimulation Sham Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transcranial Direct Current Stimulation Sham Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elizabeth H. Lacey, PhD, Study Coordinator
Organization: Georgetown University
Phone: 202-877-1124 ext 202
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01709383     History of Changes
Other Study ID Numbers: DDCF 2012062
First Submitted: August 28, 2012
First Posted: October 18, 2012
Results First Submitted: October 27, 2016
Results First Posted: July 6, 2017
Last Update Posted: July 6, 2017