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Brain Stimulation and Aphasia Treatment (tDCS)

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ClinicalTrials.gov Identifier: NCT01686373
Recruitment Status : Recruiting
First Posted : September 18, 2012
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

September 7, 2012
September 18, 2012
November 17, 2017
April 2012
January 2018   (Final data collection date for primary outcome measure)
Correct Naming on the Philadelphia Naming Test [ Time Frame: Immediately post-treatment and at follow-up ]
Number of pictures named correctly on the test
Not Provided
Complete list of historical versions of study NCT01686373 on ClinicalTrials.gov Archive Site
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Not Provided
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Brain Stimulation and Aphasia Treatment
Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes
The purpose of this study is to assess the changes in language processing of patients with chronic, post-stroke aphasia following the application of brain stimulation. The brain stimulation the investigators administer is called transcranial direct current stimulation (tDCS). It involves passing a weak electrical current through the brain between two electrodes in the form of damp sponges. One sponge will be placed over a specified area on the damaged left hemisphere, while the other sponge will be placed on the right scalp. Computer-controlled speech-language treatment will be administered during the application of tDCS.
Stroke is the leading cause of adult disability in the United States. Approximately one-third of all strokes result in acute language impairment (aphasia), with approximately one-fifth suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic aphasia remains grim, as current behavioral treatment approaches usually offer only limited-to-modest benefit. Recent advancements in understanding the relationship between low current electrical brain stimulation and cortical plasticity suggest that the effect of behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the effect of behavioral aphasia treatment. Based on these results as well as our other studies aimed at understanding how favorable brain plasticity correlates with positive treatment outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility design. Consistent with the goals of Program Announcement PAR-08-204 by the National Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether there is sufficient evidence of short term improvement in humans to justify a phase III trial."
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Aphasia
  • Device: Activa Dose II Real tDCS
  • Device: Activa Dose II Sham tDCS
  • Experimental: Activa Dose II Real tDCS
    Actual delivery of electrical stimulation
    Intervention: Device: Activa Dose II Real tDCS
  • Placebo Comparator: Activa Dose II Sham tDCS
    Sham delivery of electrical stimulation
    Intervention: Device: Activa Dose II Sham tDCS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
January 2018
January 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must be willing and able to give informed consent.
  2. Patients must be willing and able to comply with study requirements.
  3. Patients must be between 25- and 80-years of age.
  4. Patients must be native English speakers.
  5. Patients must be pre-morbidly right-handed.
  6. Patients must have sustained a one-time ischemic stroke in the left-hemisphere.
  7. Patients must be greater than 6-months post-stroke.
  8. Patients must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
  9. Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).
  10. Patients must achieve at least 65% accuracy on naming task during screening -

Exclusion Criteria:

  1. History of brain surgery
  2. Seizures during the previous 12 months
  3. Sensitive scalp (per patient report)
  4. Able to overtly name more than an average of 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.
  5. Unable to overtly name at least an average of 5 out of 80 items during the pre-treatment fMRI sessions during Visits 2 or 3.
Sexes Eligible for Study: All
25 Years to 80 Years   (Adult, Senior)
No
Contact: Astrid Fridriksson, M.A, CCC-SLP 803-777-2693 fridrika@mailbox.sc.edu
United States
 
 
NCT01686373
11560FA12
Yes
Not Provided
Not Provided
University of South Carolina
University of South Carolina
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • Medical University of South Carolina
Principal Investigator: Julius Fridriksson, PhD Director
University of South Carolina
November 2017

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