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NCT04364854 · ClinicalTrials.gov registry record · Phase 2
Speech Entrainment for Aphasia Recovery
A Phase 2 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT04364854: Completed Phase 2 study, sponsored by Medical University of South Carolina.
NCT04364854 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04364854, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
After a stroke, many people experience a language impairment called aphasia. One of the most debilitating types of aphasia is non-fluent aphasia. Non-fluent aphasia is defined by significantly reduced speech production, with the speaker producing only a few words or even less. Speech entrainment therapy (SET) is a treatment that has been shown to increase fluency in people with non-fluent aphasia. The study looks to define the best dose of SET that leads to sustained improvements in spontaneous speech production. Participants who are eligible will undergo baseline language testing, an MRI, and will be randomized into one of 4 treatment groups: SET for 3 weeks, SET for 4.5 weeks, SET for 6 weeks, and no treatment (control group).
Primary Outcome
VPM will be assessed through procedural storytelling and narrative storytelling tasks - with four items in each category. The procedural storytelling items are: 1) how to make a peanut butter and jelly sandwich, 2) how to make scrambled eggs, 3) how to brew coffee, and 4) how to wash dishes. The narrative items will be: 1) Cinderella story, 2) Little Red Riding Hood, 3) The Three Little Pigs, and 4) Goldilocks. VPM is averaged between the procedural storytelling and narrative storytelling task
Interventions
- BEHAVIORAL SET (Speech Entrainment Therapy) 3 weeks
- BEHAVIORAL SET (Speech Entrainment Therapy) 4.5 weeks
- BEHAVIORAL SET (Speech Entrainment Therapy) 6 weeks
- OTHER No Therapy 6 Weeks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-08-21 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 2 |
What the finished NCT04364854 record still lists
NCT04364854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 4 interventions - of which SET (Speech Entrainment Therapy) 3 weeks is the first listed.
NCT04364854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04364854 about?
NCT04364854 is a clinical study titled "Speech Entrainment for Aphasia Recovery". After a stroke, many people experience a language impairment called aphasia. One of the most debilitating types of aphasia is non-fluent aphasia. Non-fluent aphasia is defined by significantly reduced speech production, with the speaker producing only a few words or even less. Speech entrainment the...
What is the current status of trial NCT04364854?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2020-08-21. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT04364854?
The interventions under investigation include: SET (Speech Entrainment Therapy) 3 weeks (BEHAVIORAL), SET (Speech Entrainment Therapy) 4.5 weeks (BEHAVIORAL), SET (Speech Entrainment Therapy) 6 weeks (BEHAVIORAL), No Therapy 6 Weeks (OTHER).
Who is sponsoring clinical trial NCT04364854?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04364854's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 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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