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Rhythm-based Intervention in Aphasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581564
Recruitment Status : Suspended (Due to COVID-19)
First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Ohio State University

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. 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.


Condition or disease Intervention/treatment Phase
Aphasia Device: Rhythm-based speech therapy app (i.e., Speech Hero) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention is administered using an app installed in a smartphone or tablet pc. It does not involve drug, etc.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Investigating the Neural Mechanisms Underlying Language Recovery Through Rhythm Therapy
Estimated Study Start Date : January 15, 2021
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: Rhythm intervention Device: Rhythm-based speech therapy app (i.e., Speech Hero)
Patients with non-fluent aphasia will practice speech production during the intervention period.

Active Comparator: Non-rhythm intervention Device: Rhythm-based speech therapy app (i.e., Speech Hero)
Patients with non-fluent aphasia will practice speech production during the intervention period.




Primary Outcome Measures :
  1. Aphasia spoken word assessment [ Time Frame: 10 weeks ]
    After patients learn to speak language during the intervention period, they will be tested on both learned and new words/phrases/sentences. The number of correct words will be considered for analyses.

  2. Western Aphasia Battery (WAB) test [ Time Frame: 10 weeks ]
    Participants' language ability will be assessed with WAB (Western Aphasia Battery), whose reliability and validity have been well established in the field(Shewan & Kertesz, 1980)



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581564


Locations
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United States, Texas
Yune S Lee
Columbus, Texas, United States, 75080
Sponsors and Collaborators
Ohio State University
National Institute on Deafness and Other Communication Disorders (NIDCD)
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Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT04581564    
Other Study ID Numbers: 818479
R21DC018699 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share de-identified data
Supporting Materials: Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases