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NCT04482179 · ClinicalTrials.gov registry record · Phase 1
Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease
A Phase 1 study of Alzheimer Disease, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT04482179: Completed Phase 1 study of Alzheimer Disease, sponsored by University of Pennsylvania.
NCT04482179 is a Phase 1 study of Alzheimer Disease that has completed, run by University of Pennsylvania. The registered enrollment target is 23 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04482179, a Phase 1 study of Alzheimer Disease, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
Impaired verbal communication is a cardinal symptom of Alzheimer Disease (AD) and the source of enormous distress and disability. Effective therapies for this deficit are lacking. In light of the emerging literature demonstrating that Transcranial Magnetic Stimulation (TMS) improves general cognition in subjects with Alzheimer Disease (AD), the investigators propose to study the effectiveness of TMS as a therapy for impaired verbal communication. The hypothesis to be tested is that TMS combined with Constraint Induced Language Therapy (CILT) improves verbal communication more than sham TMS and CILT. A second aim is to use state-of-the-art neuroimaging to understand the mechanisms underlying any beneficial effect of the treatment.
Primary Outcome
The primary outcome measure will be the change in score on the Western Aphasia Battery Aphasia Quotient (WAB-AQ), a score assessing overall aphasia recovery. Scores can range from 0-100, with higher scores representing better outcomes. 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.
Conditions Studied
Interventions
- DEVICE Sham TMS
- DEVICE Active TMS
- BEHAVIORAL CILT
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-02-19 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 1 |
What the finished NCT04482179 record still lists
NCT04482179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 3 interventions - of which Sham TMS is the first listed.
NCT04482179 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04482179 about?
NCT04482179 is a clinical study titled "Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease". Impaired verbal communication is a cardinal symptom of Alzheimer Disease (AD) and the source of enormous distress and disability. Effective therapies for this deficit are lacking. In light of the emerging literature demonstrating that Transcranial Magnetic Stimulation (TMS) improves general cognitio...
What is the current status of trial NCT04482179?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-02-19. Estimated completion is 2024-08-31.
What conditions does trial NCT04482179 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT04482179?
The interventions under investigation include: Sham TMS (DEVICE), Active TMS (DEVICE), CILT (BEHAVIORAL).
Who is sponsoring clinical trial NCT04482179?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04482179 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04482179's enrollment target sits among peer trials
23 263rd of 306 higher than 44 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease 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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