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NCT04581564 · ClinicalTrials.gov registry record · NA
Rhythm-based Intervention in Aphasia
A NA study, sponsored by The University of Texas at Dallas.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT04581564: Clinical Trial NA study, sponsored by The University of Texas at Dallas.
NCT04581564 is a NA study that was terminated before completion, run by The University of Texas at Dallas. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04581564, a NA study, was terminated before completion, sponsored by The University of Texas at Dallas.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
Every year, approximately 100,000 people are diagnosed with aphasia-a language disorder leading to substantial difficulties in their daily communication. Based on the observation that many people with aphasia can sing words that they otherwise cannot speak, melodic intonation therapy (MIT) was developed in the 1970s. Although recognized as a standard aphasia treatment, the neural mechanisms of MIT have been largely unexplored. Our first goal is to identify the active ingredient of the music intervention. Although rhythm has long been considered secondary to melody, recent evidence has challenged this notion by demonstrating that rhythm alone is sufficient enough to facilitate improvements in speech fluency for people with aphasia. To corroborate the positive role of rhythm, we will train aphasic patients to leverage "rhythmic groove" for sets of sentences/phrases delivered through a fun and engaging video gaming platform. This intervention emerges from the theoretical framework, built from neuroimaging data, that language processes heavily rely on neural resources within the sensorimotor and fronto-striatal circuits that subserve rhythm/timing processes. Our second goal is to characterize the neural plasticity associated with language recovery promoted by the novel rhythm-based therapy. We hypothesize that neuroplasticity will manifest itself as increased white matter tracts, presumably due to changes in myelination in either ipsilateral or contralateral (homologues) language areas. To effectively measure myelin white matter fraction (MWF) in candidate tracts, we will mainly use a patented Laplace-transformed relaxation MRI technique. Additionally, we will measure resting-state functional connectivity using BOLD (Blood Oxygen-Level Dependent) fMRI (functional Magnetic Resonance Imaging). Lastly, we will attempt to record cortical activity using fNIRS (functional Near-Infrared Spectroscopy) during the pre-post behavioral assessments. Taken together, the proposed i
Primary Outcome
Participants will be evaluated on practiced spoken words. The mean difference of practiced spoken words before and after the intervention will be calculated.
Interventions
- BEHAVIORAL Rhythm-based speech therapy app (i.e., Speech Hero)
- BEHAVIORAL Non-rhythm based (singing) application (conventional speech therapy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-08-06 |
| Est. Completion | 2024-02-28 |
| Phase | NA |
Why NCT04581564 stopped before completion
NCT04581564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Rhythm-based speech therapy app (i.e., Speech Hero) is the first listed.
NCT04581564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04581564 about?
NCT04581564 is a clinical study titled "Rhythm-based Intervention in Aphasia". Every year, approximately 100,000 people are diagnosed with aphasia-a language disorder leading to substantial difficulties in their daily communication. Based on the observation that many people with aphasia can sing words that they otherwise cannot speak, melodic intonation therapy (MIT) was devel...
What is the current status of trial NCT04581564?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2021-08-06. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT04581564?
The interventions under investigation include: Rhythm-based speech therapy app (i.e., Speech Hero) (BEHAVIORAL), Non-rhythm based (singing) application (conventional speech therapy) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04581564?
This trial is sponsored by The University of Texas at Dallas, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04581564's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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