Rhythm-based Intervention in Aphasia

NCT04581564 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-07-14

Study results available
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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 interdisciplinary research has theoretical, methodological, and clinical innovations and significance. This exploratory work will serve as a critical stepping stone toward unraveling the therapeutic component of music in neurological disorders and will provide evidence-based guidance to the clinicians and therapists.

Conditions

  • Aphasia

Interventions

BEHAVIORAL

Rhythm-based speech therapy app (i.e., Speech Hero)

Participants will be issued a tablet device pre-installed with a rhythm-based application. They will initially be given a tutorial on how to use the application and encouraged to use application on a daily basis but at the least 5 times a week.

BEHAVIORAL

Non-rhythm based (singing) application (conventional speech therapy)

Participants will be issued a tablet device pre-installed with a singing-based application. They will initially be given a tutorial on how to use the application and encouraged to use application on a daily basis but at the least 5 times a week.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH
  • The University of Texas at Dallas

    lead OTHER

Principal Investigators

  • Yune Lee, PhD · UT Dallas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2024-02-28
Completion
2024-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04581564 on ClinicalTrials.gov