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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01709383
First Posted: October 18, 2012
Last Update Posted: July 6, 2017
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.
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
Georgetown University
Results First Submitted: October 27, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Transcranial Direct Current Stimulation   Sham Stimulation
STARTED   24   14 
Completed Treatment   24   14 
Completed Follow-ups   23   14 
Included in Analysis   22   13 
COMPLETED   23   14 
NOT COMPLETED   1   0 
Lost to Follow-up                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
People with aphasia due to left hemisphere stroke

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Transcranial Direct Current Stimulation   Sham Stimulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   14   38 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (10.8)   59.8  (8.7)   60.0  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  33.3%      5  35.7%      13  34.2% 
Male      16  66.7%      9  64.3%      25  65.8% 
Region of Enrollment 
[Units: Participants]
     
United States   24   14   38 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Western Aphasia Battery - Revised: Naming and Word Finding Score   [ Time Frame: Change from baseline to one day after treatment ]

2.  Secondary:   Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient   [ Time Frame: Change from baseline to 1 day after treatment ]

3.  Secondary:   Philadelphia Naming Test (PNT)   [ Time Frame: 1 day after treatment ]

4.  Secondary:   Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)   [ Time Frame: 3 weeks post-treatment ]

5.  Secondary:   Cognitive-Linguistic Quick Test (CLQT)   [ Time Frame: Change from baseline to 1 day after treatment ]

6.  Secondary:   Reading Assessments   [ Time Frame: Change from baseline to 1 day after treatment ]

7.  Secondary:   Motricity Index   [ Time Frame: Change from baseline to 1 day after treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: ehl4@georgetown.edu


Publications of Results:

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