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Terminated Not applicable Interventional Results available

Rhythm-based Intervention in Aphasia

ClinicalTrials.gov ID: NCT04581564

Public ClinicalTrials.gov record NCT04581564. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Investigating the Neural Mechanisms Underlying Language Recovery Through Rhythm Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04581564
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Enrollment
4 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 5, 2021
Primary completion
Feb 27, 2024
Completion
Feb 27, 2024
Last update posted
Jul 13, 2025

2021 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Yune S Lee Richardson Texas 75080

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04581564, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 13, 2025 · Synced Sep 2, 2026

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