Transcranial Direct Current Stimulation for Primary Progressive Aphasia
Baseline Performance Predicts tDCS-mediated Improvements in Language Symptoms in Primary Progressive Aphasia
1 other identifier
interventional
16
1 country
1
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 primary progressive aphasia (PPA) primarily characterized by difficulties with speech production.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedStudy Start
First participant enrolled
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2020
CompletedResults Posted
Study results publicly available
June 3, 2021
CompletedJune 3, 2021
June 1, 2021
2.7 years
October 5, 2016
March 18, 2021
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Aphasia Severity (WAB-AQ): Effects of Active tDCS (Baseline vs. 0 Weeks Immediately Following 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.
Difference in WAB-AQ from Baseline at 0-weeks Post-stimulation
Secondary Outcomes (1)
Naming Ability (WAB Naming Subtest): Effects of Active tDCS Baseline vs. 0 Weeks Immediately Following Stimulation
Difference in WAB Naming Subtest from Baseline at 0-weeks Post-stimulation
Study Arms (2)
Real tDCS
EXPERIMENTALTranscranial 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.
Sham tDCS
SHAM COMPARATORSham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of real tDCS.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
McConathey EM, White NC, Gervits F, Ash S, Coslett HB, Grossman M, Hamilton RH. Baseline Performance Predicts tDCS-Mediated Improvements in Language Symptoms in Primary Progressive Aphasia. Front Hum Neurosci. 2017 Jun 30;11:347. doi: 10.3389/fnhum.2017.00347. eCollection 2017.
PMID: 28713256DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Withdrawal of two participants resulted in 14/16 who completed at least one treatment arm; additional participants were excluded due to not completing both treatment arms (N=2) and misdiagnosis (N=1). Data analyzed for N=13 participants for baseline to 0-week post-stimulation. One participant's second treatment arm was delayed by one week.
Results Point of Contact
- Title
- Dr. H. Branch Coslett
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
H B Coslett, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 10, 2016
Study Start
June 16, 2017
Primary Completion
March 10, 2020
Study Completion
March 13, 2020
Last Updated
June 3, 2021
Results First Posted
June 3, 2021
Record last verified: 2021-06