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Rhythm-based Intervention in Aphasia

Primary Purpose

Aphasia

Status
Suspended
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rhythm-based speech therapy app (i.e., Speech Hero)
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Yune S Lee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rhythm intervention

Non-rhythm intervention

Arm Description

Outcomes

Primary Outcome Measures

Aphasia spoken word assessment
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.
Western Aphasia Battery (WAB) test
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)

Secondary Outcome Measures

Full Information

First Posted
August 28, 2020
Last Updated
October 8, 2020
Sponsor
Ohio State University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT04581564
Brief Title
Rhythm-based Intervention in Aphasia
Official Title
Investigating the Neural Mechanisms Underlying Language Recovery Through Rhythm Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Suspended
Why Stopped
Due to COVID-19
Study Start Date
January 15, 2021 (Anticipated)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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 PC or smartphone. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The intervention is administered using an app installed in a smartphone or tablet pc. It does not involve drug, etc.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rhythm intervention
Arm Type
Experimental
Arm Title
Non-rhythm intervention
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Rhythm-based speech therapy app (i.e., Speech Hero)
Intervention Description
Patients with non-fluent aphasia will practice speech production during the intervention period.
Primary Outcome Measure Information:
Title
Aphasia spoken word assessment
Description
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.
Time Frame
10 weeks
Title
Western Aphasia Battery (WAB) test
Description
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)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Yune S Lee
City
Columbus
State/Province
Texas
ZIP/Postal Code
75080
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share de-identified data

Learn more about this trial

Rhythm-based Intervention in Aphasia

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