Clinical Trial: Baseline Severity and tDCS in PPA

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Baseline Performance Predicts tDCS-mediated Improvements in Language Symptoms in Primary Progressive Aphasia

Brief Summary: In the present sham-controlled study, the investigators examine whether tDCS could be used to enhance language abilities (e.g., picture naming) in individuals with PPA variants primarily characterized by difficulties with speech production (non-fluent and logopenic).

Detailed Summary: Primary Progressive Aphasia (PPA) is a neurodegenerative condition characterized by insidious irreversible loss of language abilities. Prior studies suggest that transcranial direct current stimulation (tDCS) directed toward language areas of the brain may help to ameliorate symptoms of PPA. In the current study, the investigators are examining whether tDCS could be used to enhance language abilities (e.g., picture naming) in individuals with PPA variants primarily characterized by difficulties with speech production (non-fluent and logopenic). Participants are being recruited from the Penn Frontotemporal Dementia Center to receive 10 days of both real and sham tDCS (counter-balanced, full-crossover design; participants are naïve to stimulation condition). A battery of language tests are being administered at baseline, immediately post-tDCS (real and sham), and six weeks and twelve weeks following stimulation. Real tDCS may improve language performance in some individuals with PPA. Specifically, the investigators expect that tDCS will be more effective in people whose baseline performance is worse based on previous research. Severity of deficits at baseline may be an important factor in predicting which patients will respond positively to language-targeted tDCS therapies.
Sponsor: University of Pennsylvania

Current Primary Outcome:

  • Language assessment: Immediately post-stimulation [ Time Frame: pre-stimulation, immediately post-stimulation ]
    A battery of language tests was administered at baseline, immediately post-tDCS (real and sham) following the termination of the tDCS session on the same day. Each test within this battery is scored for performance accuracy. The different tests assess different domains of language function, and have different numbers of items. In order to assess global language performance across different domains of language ability, a single composite score will be computed for each participant at each time-point by z-transforming the data from each test to facilitate comparisons across tests with different measurement scales, and averaging the z-scores to create a single composite z-score that captures language performance in general. Difference scores will be computed from these z-scores to assess change in performance at the post-stimulation timepoint relative to the most recent baseline to compare the relative impact of real vs. sham tDCS on global language performance.
  • Language assessment: Six weeks post-stimulation [ Time Frame: pre-stimulation, six weeks post-stimulation ]
    A battery of language tests was administered at baseline and six weeks following stimulation. Each test within this battery is scored for performance accuracy. The different tests assess different domains of language function, and have different numbers of items. In order to assess global language performance across different domains of language ability and over time, a single composite score will be computed for each participant at each time-point by z-transforming the data from each test to facilitate comparisons across tests with different measurement sca

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University of Pennsylvania

    Dates:
    Date Received: October 5, 2016
    Date Started: September 2014
    Date Completion: October 2017
    Last Updated: October 6, 2016
    Last Verified: October 2016