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NCT05386394 · ClinicalTrials.gov registry record · Phase 2
Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia
A Phase 2 study of Primary Progressive Aphasia and Logopenic Progressive Aphasia, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 3
- Study locations
NCT05386394: Recruiting Phase 2 study of Primary Progressive Aphasia and Logopenic Progressive Aphasia, sponsored by Johns Hopkins University.
NCT05386394 is a Phase 2 study of Primary Progressive Aphasia and Logopenic Progressive Aphasia that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 180 participants, above the 81-participant average among 15 other Primary Progressive Aphasia trials with a reported enrollment target (122% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05386394, a Phase 2 study of Primary Progressive Aphasia and Logopenic Progressive Aphasia, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 3
- Study locations
Study Summary
While many have strongly suggested that transcranial direct current stimulation (tDCS) may represent a beneficial intervention for patients with primary progressive aphasia (PPA), this promising technology has not yet been applied widely in clinical settings. This treatment gap is underscored by the absence of any neurally-focused standard-of-care treatments to mitigate the devastating impact of aphasia on patients' family, work, and social lives. Given that tDCS is inexpensive, easy to use (it is potentially amenable to home use by patients and caregivers), minimally invasive, and safe there is great promise to advance this intervention toward clinical use. The principal reason that tDCS has not found wide clinical application yet is that its efficacy has not been tested in large, multi-center, clinical trials. In this study, scientists in the three sites that have conducted tDCS clinical trials in North America-Johns Hopkins University and the University of Pennsylvania in the US, and the University of Toronto in Canada, will collaborate to conduct a multi-site, Phase II clinical trial of tDCS a population in dire need of better treatments.
Primary Outcome
The primary outcome measure will be tDCS-induced change in performance on phonemic accuracy of trained items. Phonemic accuracy will be calculated on a scale of 0-100% with a higher number reflecting higher accuracy. The change in performance from baseline will be compared between the tDCS condition and the sham condition.
Conditions Studied
Interventions
- DEVICE Active tDCS + Language Therapy
- DEVICE Sham tDCS + Language Therapy
Study Locations (3)
Maryland
- Johns Hopkins Hospital - Baltimore
Pennsylvania
- University of Pennsylvania - Philadelphia
Ontario
- Baycrest Centre for Geriatric Care - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2024-02-13 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 2 |
What NCT05386394 shows while recruiting
NCT05386394 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 81-participant average among 15 other Primary Progressive Aphasia trials with a reported enrollment target (122% higher).
The record links to 3 conditions, with Primary Progressive Aphasia appearing as the primary indexed condition, and to 2 interventions - of which Active tDCS + Language Therapy is the first listed.
NCT05386394 reports a single indexed study location in Maryland, Pennsylvania, Ontario.
Frequently Asked Questions
What is clinical trial NCT05386394 about?
NCT05386394 is a clinical study titled "Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia". While many have strongly suggested that transcranial direct current stimulation (tDCS) may represent a beneficial intervention for patients with primary progressive aphasia (PPA), this promising technology has not yet been applied widely in clinical settings. This treatment gap is underscored by the...
What is the current status of trial NCT05386394?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2024-02-13. Estimated completion is 2028-02-01.
What conditions does trial NCT05386394 study?
This clinical trial studies the following conditions: Primary Progressive Aphasia, Logopenic Progressive Aphasia, Non-Fluent Primary Progressive Aphasia.
What interventions are being tested in trial NCT05386394?
The interventions under investigation include: Active tDCS + Language Therapy (DEVICE), Sham tDCS + Language Therapy (DEVICE).
Who is sponsoring clinical trial NCT05386394?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05386394 being conducted?
This trial has 3 study locations across Maryland, Pennsylvania, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Progressive Aphasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05386394's enrollment target sits among peer trials
180 3rd of 15 higher than 13 of 15 other Primary Progressive Aphasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Progressive Aphasia 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.
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