- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05248295
Investigating the Effects of Rhythm and Entrainment on Fluency in People With Aphasia
April 3, 2023 updated by: Lauryn Zipse, Ph.D., CCC-SLP, MGH Institute of Health Professions
Speaking in unison with another person is included as a part of many treatment approaches for aphasia.
It is not well understood why and how this technique works.
One goal of this study is to determine who benefits from speaking in unison, and what characteristics of speech are most helpful.
Another goal is to investigate a possible mechanism for this benefit: why does speaking in unison help?
A possible mechanism for this benefit is examined, by testing whether the degree of alignment of a person's speech with that of another speaker can account for unison benefit.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Aphasia is an acquired language disorder, most commonly due to stroke.
It can affect an individual's ability to speak, understand spoken language, read, and write.
Many treatments designed to improve spoken language in persons with aphasia (PWAs) use unison speech, having the person with aphasia speak along with the clinician or with a recording.
One goal of this study is to determine who benefits from speaking in unison, and what characteristics of speech help them the most.
Another goal is to investigate a possible mechanism for this benefit: why does speaking in unison help?
This knowledge is important because understanding who benefits from this commonly used and potentially powerful therapy component, under which conditions they benefit, and why they do, is critical for customizing therapy so it can be as effective and efficient as possible.
Unison speech is conducted using one of two different timing patterns: (1) a natural conversational pattern, which is used in everyday conversations, or (2) a metrical pattern, which follows a beat-based timing framework, as in songs or some poems.
In either case, precisely aligning one's speech with that of another person (i.e., entraining one's speech) requires prediction: each speaker must plan their own speech motor commands before having heard the other speaker say the words they are planning.
Natural conversational timing requires the speaker to make use of knowledge about language, particularly grammar, to align with the other person.
In contrast, a metrical pattern allows a speaker to predict speech timing without relying heavily on language-based knowledge.
Given that many PWAs have impaired grammar, we hypothesize that most PWAs will benefit more from speaking in unison to sentences with metrical vs. conversational timing patterns.
However, there is great variation in linguistic, motor speech, and timing skills across PWAs, so metrical and conversational timing patterns are likely to have different degrees of effectiveness for different individuals.
Results from this study will demonstrate how individual characteristics and speech timing affect whether or not a person with aphasia benefits from speaking in unison.
Results will also indicate whether a speaker's ability to predict speech timing is necessary for a benefit of unison speech.
Prediction ability will be measured by how closely the speaker aligns their speech with a spoken model.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02129
- Recruiting
- MGH IHP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Native-speaker fluency in American English (prior to stroke for people with aphasia)
- Controls must report no history of speech, language, neurological disorders, or stroke
- People with aphasia must be at least 6-months post-stroke, and aphasia must be due to stroke
Exclusion Criteria:
- Inadequate hearing ability to reliably complete task: fail hearing screen
- Inadequate cognitive ability to understand and remember task: fail cognition screening (different measures for controls and people with aphasia)
- Inadequate speech repetition ability to complete task, or to be considered a control: fail speech repetition screening (different thresholds for controls and people with aphasia)
- Inadequate auditory comprehension ability to understand task: fail auditory comprehension screen (people with aphasia only)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
All participants will repeat sentences under four speech conditions, in a 2x2 design
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Participants will repeat sentences in four conditions, in a 2x2 design with the factors unison vs. solo repetition, and metrical vs. conversational speech timing.
Measures of speech accuracy and timing will be collected.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent syllables correct
Time Frame: 1 day study visit
|
The percentage of syllables correctly repeated from the target sentences will be computed for each of the 4 experimental conditions.
A protocol will be used to score syllables for correctness.
|
1 day study visit
|
Percent syllables entrained
Time Frame: 1 day study visit
|
Of the syllables attempted by the participant, the percent that are classified as "entrained," meaning they are aligned in time with the target syllable.
Thresholds for classifying a syllable as entrained are based on control data.
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1 day study visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 4, 2018
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
February 4, 2022
First Submitted That Met QC Criteria
February 18, 2022
First Posted (Actual)
February 21, 2022
Study Record Updates
Last Update Posted (Actual)
April 4, 2023
Last Update Submitted That Met QC Criteria
April 3, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P001160
- R15DC019231 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aphasia
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University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Aphasia | Stroke, Ischemic | Aphasia, Broca | Aphasia, Anomic | Aphasia, Global | Aphasia, Fluent | Aphasia, Mixed | Aphasia, Jargon | Aphasia, Expressive | Aphasia, ConductionUnited States
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University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
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Institute for Bioengineering of CataloniaHospital Universitari Joan XXIII de Tarragona.; Universitat Pompeu FabraCompletedAphasia | Aphasia, Broca | Aphasia, Wernicke | Aphasia, Fluent | Aphasia, NonfluentSpain
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Flint Rehabilitation Devices, LLCUniversity of TexasCompleted
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Mayo ClinicNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingPrimary Progressive Aphasia | Apraxia of Speech | PPA | Non-fluent Aphasia | Primary Progressive Non-fluent AphasiaUnited States
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University of California, BerkeleyUniversity of California, San Francisco; California State University, East Bay and other collaboratorsRecruitingAphasia | Aphasia, Acquired | Aphasia Non Fluent | Aphasia, FluentUnited States
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Mayo ClinicCompletedPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | PPA | Non-fluent Aphasia | Progressive AphasiaUnited States
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Montreal Heart InstituteActive, not recruitingNeurodegenerative Diseases | Primary Progressive Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Non-fluent AphasiaCanada
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Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
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University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
Clinical Trials on Unison speech (vs. solo)
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Sonova AGCompleted
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Northeastern UniversityBoston University; University of Delaware; Cornell UniversityRecruitingAutism Spectrum Disorder | Language Development | LiteracyUnited States