Rhythm-based Intervention in Aphasia

NCT04581564 | Terminated Results

• 2 other identifiers: 21-4R21DC018699
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Aphasia Spoken Word Assessment

  Participants will be evaluated on practiced spoken words. The mean difference of practiced spoken words before and after the intervention will be calculated.

  10 weeks

• Western Aphasia Battery (WAB) Test

  Participants' language ability will be assessed with Western Aphasia Battery (WAB), whose reliability and validity have been well established. The mean difference before and after the intervention will be calculated. The Aphasia Quotient is scored on a scale of 0-100. Lower scores represent more severe aphasia and higher scores represent lesser aphasia severity.

  10 weeks

Study Arms (2)

Rhythm intervention

EXPERIMENTAL

Practice speech production daily through rhythmic activity

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

Non-rhythm intervention

ACTIVE COMPARATOR

Conventional speech production therapy without the use of rhythmic activities

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

Interventions

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

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.

Rhythm intervention

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

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.

Non-rhythm intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be over six months post-stroke
• Limb motor function, at least on the left side, should remain relatively intact
• Be able to name at least few items
• Must not suffer from any other type of neurological disease.

You may not qualify if:

• less than six months post-stroke
• Metal in the body
• Comorbidity with other neurological disorders (e.g., depression)

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Yune S Lee

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Aphasia

Interventions

Singing

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phonation; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Limitations and Caveats

The procedures specified in the protocol were determined to be non-compliant by the IRB (Institutional Review Board) and the deviations may have compromised integrity of the data collected and analyzed.

Results Point of Contact

• Title: Dr. Yune Lee
• Organization: Assistant Professor. Speech, Language and Hearing

yune.lee@utdallas.edu

972-883-5639

Study Officials

• Yune Lee, PhD

  UT Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention is administered using an app installed in a smart phone or tablet personal computer. It does not involve drug, etc.

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: October 9, 2020
• Study Start: August 6, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)