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AphasiaNCT04581564

Rhythm-based Intervention in Aphasia

A study testing Rhythm-based speech therapy app (i.e., Speech Hero) and Non-rhythm based (singing) application (conventional speech therapy) in people with Aphasia, run by The University of Texas at Dallas at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Aphasia
What is being tested?
Rhythm-based speech therapy app (i.e., Speech Hero) and Non-rhythm based (singing) application (conventional speech therapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
6 Aug 2021to 28 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yune S Lee

    Richardson, Texas, 75080

Other trials in United States

About this study

Official title: Investigating the Neural Mechanisms Underlying Language Recovery Through Rhythm Therapy

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.

Read more

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.

Read the detailed description

Every year, approximately 800,000 people have a stroke in the United States alone. Among these individuals, roughly 100,000 are diagnosed with aphasia-a disorder characterized by profound challenges in daily communication with their families and peers. Notably, many individuals with aphasia can sing despite their speech difficulties, an observation which led to the development of melodic-intonation therapy (MIT) in the 1970s. Although MIT has since been accepted as a viable aphasia therapy by the American Academy of Neurology, the underlying neurological mechanisms that enable speech recovery remain poorly understood. Here, we propose a highly interdisciplinary approach to study the neural mechanisms of language recovery in aphasia through a novel rhythm-based language intervention.

Our ultimate goal is to help clinicians and therapists optimize aphasia treatment by elucidating the neural basis underlying music-induced language recovery through multimodal neuroimaging and novel statistical analysis. In particular, we will test a hypothesis that rhythm alone is sufficient to facilitate language recovery, without melody To explore this hypothesis, we recently devised a novel framework for music-based language therapy that solely leverages rhythm to facilitate language production at the phrase or sentence level. Our therapy was used in a case study with a patient with chronic aphasia who had severely impaired speech fluency due to a large unilateral stroke in the left hemisphere. Following eight weeks of rhythm therapy, she exhibited remarkable improvement in speech production (i.e., from 1-2 spontaneous words to 16 sentences made from 42 words), and increased functional and structural connectivity within key regions of interest associated with the right sensorimotor network. While compelling, these preliminary data warrant further validation using proper active controls and a larger sample size, a goal to be achieved through the proposed research. We have since translated the rhythm therapy into a fun and engaging game termed "TheraBeat" that can be installed on a tablet Personal Computer or smart phone. In the proposed research, we will use TheraBeat as a home-based aphasia therapeutic intervention to minimize the burden of patient travel and increase accessibility to therapy. The proposed study will be accomplished by pursuing the following specific aims:. This prediction is based upon the theoretical and neuroscientific framework that demonstrates how language heavily relies on rhythm processes mediated by the bilateral sensorimotor network.

Aim 1. Determine the therapeutic role of rhythm in speech recovery for people with aphasia. Based on recent evidence garnered by our group as well as others, we expect that rhythm-based rehabilitation will enhance speech fluency in people with chronic aphasia, i.e., our target patients who are beyond six months after the onset of stroke. This hypothesis will be tested by directly comparing post-therapy outcomes of the treatment group, who will practice speech production daily through rhythmic activity, to an active control group who will receive conventional speech production therapy without the use of rhythmic activities.

Aim 2. Characterize the neural plasticity promoted by rhythm-based intervention. We hypothesize that daily participation in our new therapy program will promote neuroplasticity along the sensorimotor network, especially within the intact perilesional left or right fronto-striatal circuits that are known to play a key role in speech production and fluency. To determine structural neuroplasticity following the intervention, we will utilize patented myelin-based MRI in combination with diffusion tensor imaging (DTI). To explore functional neuroplasticity, we will use both resting-state fMRI and functional near-infrared spectroscopy (fNIRS). These structural and functional data will be analyzed via a novel statistical shape analysis that captures morphological changes, which cannot be detected by simple statistical approaches.

By using an innovative rhythm-based therapeutic intervention and cutting-edge neuroimaging techniques, we will address hitherto unknown questions regarding how and why music works as a therapeutic regimen for aphasia rehabilitation. With expertise in aphasia rehabilitation, neuroimaging, computer science, and data analytics, our interdisciplinary research team is well poised to undertake this investigation. The proposed research will serve as a critical stepping stone toward understanding the therapeutic role of music in neurological disorders. Our results will lay the foundations for future studies on music-induced language recovery.

Conditions
Aphasia
Being tested
Rhythm-based speech therapy app (i.e., Speech Hero), Non-rhythm based (singing) application (conventional speech therapy)
Medical subject headings
Aphasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

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

    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.

Study groups in NCT04581564
Study groupRoleWhat they receive
Rhythm interventionExperimentalPractice speech production daily through rhythmic activity
Receives: Behavioral: Rhythm-based speech therapy app (i.e., Speech Hero)
Non-rhythm interventionActive comparatorConventional speech production therapy without the use of rhythmic activities
Receives: Behavioral: Non-rhythm based (singing) application (conventional speech therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 weeks

  2. 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.

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2020
  2. Study start6 Aug 2021
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Why it stopped: Suspension of IRB (Institutional Review Board) Approval

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention is administered using an app installed in a smart phone or tablet personal computer. It does not involve drug, etc.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04581564
Sponsor's protocol ID
21-4
Other IDs
R21DC018699
Status last verified
Jun 2025
First submitted
28 Aug 2020
Last updated
14 Jul 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data (IPD) will be shared

Questions about this trial

What is this clinical trial studying?

A study testing Rhythm-based speech therapy app (i.e., Speech Hero) and Non-rhythm based (singing) application (conventional speech therapy) in people with Aphasia, run by The University of Texas at Dallas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aphasia Spoken Word Assessment (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.

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