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
  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 Phase
Aphasia
Device: Transcranial Direct Current Stimulation
Device: Sham Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    This is a composite measure of verbal expression skills including tests of naming, verbal fluency, and sentence completion.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 112
Study Start Date: December 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transcranial Direct Current Stimulation 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 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
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709383

Contacts
Contact: Alexa Desko 202-687-5205 ad655@georgetown.edu

Locations
United States, District of Columbia
MedStar National Rehabilitation Hospital Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Peter Turkeltaub, M.D., Ph.D.         
Sub-Investigator: Elizabeth Lacey, Ph.D.         
Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
Principal Investigator: Peter Turkeltaub, M.D., Ph.D.         
Sub-Investigator: Elizabeth Lacey, Ph.D.         
Sponsors and Collaborators
Georgetown University
Medstar 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
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Aphasia
Stroke
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014