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

This study has been completed.
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01709383
First received: August 28, 2012
Last updated: June 6, 2017
Last verified: October 2016
  Purpose
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.

Condition Intervention
Aphasia Device: Transcranial Direct Current Stimulation Device: Sham Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Enhancing Left Lateralization Using Transcranial Direct Current Stimulation Improve Recovery From Post-Stroke Aphasia?

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Western Aphasia Battery - Revised: Naming and Word Finding Score [ Time Frame: 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 Outcome Measures:
  • Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient [ Time Frame: 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).

  • Philadelphia Naming Test (PNT) [ Time Frame: 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) [ Time Frame: 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".

  • Cognitive-Linguistic Quick Test (CLQT) [ Time Frame: 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

  • Reading Assessments [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 38
Study Start Date: December 2012
Study Completion Date: September 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transcranial Direct Current Stimulation
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
Device: 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 Comparator: Sham Stimulation
Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
Device: 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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Exclusion Criteria for the optional MRI portion of the study:

  • Presence of metal in the body (except titanium)
  • Claustrophobia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709383

Locations
United States, District of Columbia
MedStar National Rehabilitation Hospital
Washington, D.C., District of Columbia, United States, 20010
Georgetown University
Washington, D.C., District of Columbia, United States, 20057
Sponsors and Collaborators
Georgetown University
Medstar Health Research Institute
Investigators
Principal Investigator: Peter Turkeltaub, M.D., Ph.D. Georgetown University and MedStar National Rehabilitation Hospital
  More Information

Publications:
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01709383     History of Changes
Other Study ID Numbers: DDCF 2012062
Study First Received: August 28, 2012
Results First Received: October 27, 2016
Last Updated: June 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Georgetown University:
Aphasia
Stroke
Transcranial Direct Current Stimulation
Neuroplasticity

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017