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

This study is currently recruiting participants.
Verified January 2014 by Georgetown University
Sponsor:
Collaborator:
Medstar Research Institute
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01709383
First received: August 28, 2012
Last updated: January 9, 2014
Last verified: January 2014

August 28, 2012
January 9, 2014
December 2012
July 2015   (final data collection date for primary outcome measure)
Western Aphasia Battery - Revised: Naming and Word Finding score [ Time Frame: Change from baseline to one day after treatment ] [ Designated as safety issue: No ]
This is a composite measure of verbal expression skills including tests of naming, verbal fluency, and sentence completion.
Same as current
Complete list of historical versions of study NCT01709383 on ClinicalTrials.gov Archive Site
  • Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and overall Aphasia Quotient [ Time Frame: Immediately; 2 weeks post-treatment; 12 weeks post-treatment ] [ Designated as safety issue: No ]
    The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description; a measure of word and sentence repetition; a composite measure of yes/no questions, auditory word recognition, and following sequential commands; and an overall aphasia severity score.
  • Philadelphia Naming Test (PNT) [ Time Frame: Immediately; 2 weeks post-treatment; 12 weeks post-treatment ] [ Designated as safety issue: No ]
    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.
  • Boston Diagnostic Aphasia Examination (BDAE): Verbal agility subtest [ Time Frame: Immediately; 2 weeks post-treatment; 12 weeks post-treatment ] [ Designated as safety issue: No ]
    A measure of annunciation to assess the impact of tDCS on slurring of speech and verbal apraxia.
  • Subjective assessments including: Communicative Effectiveness Index, Stroke and Aphasia Quality of Life Scale, and Stroke Aphasic Depression Questionnaire [ Time Frame: Immediately; 2 weeks post-treatment; 12 weeks post-treatment ] [ Designated as safety issue: No ]
    A set of questionnaires to be administered to subjects and immediate family members in order to assess the impact of language impairments on functional communication skills and overall quality of life.
  • Cognitive-Linguistic Quick Test (CLQT) [ Time Frame: Immediately; 2 weeks post-treatment; 12 weeks post-treatment ] [ Designated as safety issue: No ]
    The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, 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, and visuospatial skills.
  • Reading assessments [ Time Frame: Immediately; 2 weeks post-treatment; 12 weeks post-treatment ] [ Designated as safety issue: No ]
    A set of reading tasks designed to assess oral reading of real words and non-words at the single word level.
  • Motricity Index [ Time Frame: Immediately; 2 weeks post-treatment; 12 weeks post-treatment ] [ Designated as safety issue: No ]
    An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction.
Same as current
Not Provided
Not Provided
 
Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia
Can Enhancing Left Lateralization Using Transcranial Direct Current Stimulation Improve Recovery From Post-Stroke Aphasia?

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Aphasia
  • 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.
  • 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.
  • Active Comparator: Transcranial Direct Current Stimulation
    Intervention: Device: Transcranial Direct Current Stimulation
  • Sham Comparator: Sham Stimulation
    Intervention: Device: Sham Stimulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
July 2015
July 2015   (final data collection date for primary outcome measure)

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 MS, 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 SSRI or SNRI 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
Both
18 Years and older
No
Contact: Alexa Desko 202-687-5205 ad655@georgetown.edu
United States
 
NCT01709383
DDCF 2012062
No
Georgetown University
Georgetown University
Medstar Research Institute
Principal Investigator: Peter Turkeltaub, M.D., Ph.D. Georgetown University and MedStar National Rehabilitation Hospital
Georgetown University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP