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Completed

NCT Number: NCT02928848

Transcranial Direct Current Stimulation for Primary Progressive Aphasia

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 primary progressive aphasia (PPA) primarily characterized by difficulties with speech production.

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Key information

Conditions

Primary Progressive Aphasia Aphasia Aphasia, Primary Progressive Brain Diseases Central Nervous System Diseases Communication Disorders Dementia Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between the ages of 45-80
  • Native English speaker
  • Diagnosed with Primary Progressive Aphasia
  • Subject understands nature of study and able to give informed consent

Exclusion criteria

  • Cognitive impairment of sufficient severity to preclude giving informed consent
  • History of seizures or unexplained loss of consciousness
  • Previous craniotomy or any breach of the skull
  • Metallic objects in the head or face other than dental braces, fillings or implants
  • Pacemaker or implantable cardioverter-defibrillator
  • Pregnant

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The stimulation involves 20 minutes of constant stimulation at 1.5 mA.

Primary outcomes

  1. Aphasia Severity (WAB-AQ): Effects of Active tDCS (Baseline vs. 0 Weeks Immediately Following Stimulation)

    Time frame: Difference in WAB-AQ from Baseline at 0-weeks Post-stimulation

    The Western Aphasia Battery (WAB) was administered at baseline and immediately post-tDCS (real; sham) following the termination of the tDCS session on the same day (0 week). We computed WAB-Aphasia Quotient (WAB-AQ), a measure of overall aphasia severity with higher scores indicating better language performance. The WAB assesses the following language domains in subtests: fluency, comprehension, repetition, and naming. We examined change in WAB-AQ and each of the sub-tests from baseline. Difference scores were computed by subtracting the post-intervention score (0 weeks) from baseline for each study arm to assess the impact of real/active vs sham tDCS on severity and each sub-test. Scale title: WAB-AQ; scale values: 0-100; higher scores=better outcome.

Secondary outcomes

  1. Naming Ability (WAB Naming Subtest): Effects of Active tDCS Baseline vs. 0 Weeks Immediately Following Stimulation

    Time frame: Difference in WAB Naming Subtest from Baseline at 0-weeks Post-stimulation

    WAB-naming subtest used common objects as stimuli. Participants were required to name the objects. Three-point maximum score could be earned for each stimulus and a total of 60-points could be earned on this task; points were deducted if the response was incorrect and required a cue or if the response included a paraphasia.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2016
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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