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NCT04046991 · ClinicalTrials.gov registry record · Phase 2
Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT04046991: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT04046991 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04046991, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
This is a double-blind, sham-controlled, crossover study in which subjects with the non-fluent/agrammatic and logopenic variants of primary progressive aphasia (naPPA and lvPPA, respectively) will undergo language testing and structural and functional brain imaging before and after receiving 10 semi-consecutive daily sessions of real or sham high-definition transcranial direct current stimulation (HD-tDCS) paired with modified constraint-induced language therapy (mCILT). Language testing and brain imaging will be repeated immediately after completion of and 3 months following completion of treatment. The 3-month follow-up will be the primary endpoint. The investigators will examine changes in language performance induced by HD-tDCS + mCILT compared to sham HD-tDCS + mCILT. The investigators will also use network science to analyze brain imaging (fMRI) data to identify network properties associated with baseline PPA severity and tDCS-induced changes in performance. This study will combine knowledge gained from our behavioral, imaging, and network data in order to determine the relative degrees to which these properties predict whether persons with PPA will respond to intervention.
Primary Outcome
The primary outcome measure will be the change in score on the WAB-AQ, a score assessing overall aphasia recovery. Scores can range from 0-100. 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. A score of 93 or higher is considered recovered.
Interventions
- DEVICE high-definition transcranial direct current stimulation
- BEHAVIORAL modified constraint-induced language therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2020-08-17 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
What the finished NCT04046991 record still lists
NCT04046991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which high-definition transcranial direct current stimulation is the first listed.
NCT04046991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04046991 about?
NCT04046991 is a clinical study titled "Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS". This is a double-blind, sham-controlled, crossover study in which subjects with the non-fluent/agrammatic and logopenic variants of primary progressive aphasia (naPPA and lvPPA, respectively) will undergo language testing and structural and functional brain imaging before and after receiving 10 semi...
What is the current status of trial NCT04046991?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2020-08-17. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT04046991?
The interventions under investigation include: high-definition transcranial direct current stimulation (DEVICE), modified constraint-induced language therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04046991?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04046991's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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