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NCT03887481 · ClinicalTrials.gov registry record · NA
Targeting Language-specific and Executive-control Networks With Transcranial Direct Current Stimulation in Logopenic Variant PPA
A NA study of Primary Progressive Aphasia and Logopenic Progressive Aphasia, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03887481: Recruiting NA study of Primary Progressive Aphasia and Logopenic Progressive Aphasia, sponsored by Johns Hopkins University.
NCT03887481 is a NA study of Primary Progressive Aphasia and Logopenic Progressive Aphasia that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 60 participants, below the 89-participant average among 15 other Primary Progressive Aphasia trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03887481, a NA study of Primary Progressive Aphasia and Logopenic Progressive Aphasia, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
AD afflicts over 5.5. million Americans and is one of the most expensive diseases worldwide. In AD the variant in which language functions are most affected are referred to as 'logopenic variant Primary Progressive Aphasia' (lvPPA). Language deficits dramatically impair communication and quality of life for both patients and caregivers. PPA usually has an early onset (50-65 years of age), detrimentally affecting work and family life. Studies have identified verbal short-term memory/working memory (vSTM/WM) as a primary deficit and cause of language impairment. In the first cycle of this award, the investigators asked the question of whether language therapy effects could be augmented by electrical stimulation. The investigators conducted the largest to-date randomized, double-blind, sham-controlled, crossover, clinical trial to determine the effects of transcranial direct current stimulation (tDCS) in PPA. The investigators found that tDCS over the left inferior frontal gyrus (L\_IFG), one of the major language hubs in the brain, significantly enhanced the effects of a written naming and spelling intervention. In addition, findings demonstrated that tDCS modulates functional connectivity between the stimulated area and other networks (e.g. functionally and structurally connected areas), and that tDCS modulates the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). In terms of tDCS, the investigators have been identified several predictors to determine the beneficience of tDCS including (a) PPA variant, (b) initial performance on cognitive/language tasks, particularly vSTM/WM, and (c) initial white-matter integrity and structure. These findings support the notion that tDCS benefits generalize beyond the treatment tasks and has led to the important question of the present study: How can we implement treatments to product benefits that maximally generalize to untrained but vital language/cognitive functions. To address the above question, the investigators wi
Primary Outcome
The investigators will assess any changes in performance from pre- to post-treatment and 1- and 3- month follow-up intervals in percent accuracy on word repetition with no delay. This will be measured using the Temple Assessment of Language and Short-Term Memory (TALSA) Test 3: Word and Non-Word Repetition Test. The investigators will compute the raw score of items correct and transform to percent correct (range: 0-100%), computing change in outcome in percent difference as well as other arithme
Conditions Studied
Interventions
- DEVICE High-definition active tDCS (HD-tDCS) + "Repeat After Me" (RAM) Treatment
- DEVICE Sham + "Repeat After Me" (RAM) Treatment
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-10-15 |
| Est. Completion | 2027-10-31 |
| Phase | NA |
What NCT03887481 shows while recruiting
NCT03887481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 89-participant average among 15 other Primary Progressive Aphasia trials with a reported enrollment target (33% lower).
The record links to 2 conditions, with Primary Progressive Aphasia appearing as the primary indexed condition, and to 2 interventions - of which High-definition active tDCS (HD-tDCS) + "Repeat After Me" (RAM) Treatment is the first listed.
NCT03887481 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03887481 about?
NCT03887481 is a clinical study titled "Targeting Language-specific and Executive-control Networks With Transcranial Direct Current Stimulation in Logopenic Variant PPA". AD afflicts over 5.5. million Americans and is one of the most expensive diseases worldwide. In AD the variant in which language functions are most affected are referred to as 'logopenic variant Primary Progressive Aphasia' (lvPPA). Language deficits dramatically impair communication and quality of ...
What is the current status of trial NCT03887481?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2022-10-15. Estimated completion is 2027-10-31.
What conditions does trial NCT03887481 study?
This clinical trial studies the following conditions: Primary Progressive Aphasia, Logopenic Progressive Aphasia.
What interventions are being tested in trial NCT03887481?
The interventions under investigation include: High-definition active tDCS (HD-tDCS) + "Repeat After Me" (RAM) Treatment (DEVICE), Sham + "Repeat After Me" (RAM) Treatment (DEVICE).
Who is sponsoring clinical trial NCT03887481?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03887481 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03887481's enrollment target sits among peer trials
60 5th of 15 higher than 9 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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