- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05248295
Investigating the Effects of Rhythm and Entrainment on Fluency in People With Aphasia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02129
- MGH IHP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: People with aphasia
Adults with stroke-based aphasia.
Designating this group as experimental reflects the focus on studying responses in people with aphasia.
All participants will complete the same 4 study conditions in a 2x2 design (Unison vs. Solo and Metrical vs. Conversational).
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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:
This is the secondary contrast in the 2x2 design described above.
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Other: Healthy controls
Adults without a history of speech, language, or neurological disorder, or stroke.
This group is intended to serve as a context-providing reference group rather than a true comparator.
All participants will complete the same 4 study conditions in a 2x2 design (Unison vs. Solo and Metrical vs. Conversational).
|
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:
This is the secondary contrast in the 2x2 design described above.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percent Syllables Correct
Time Frame: 1 day study visit
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The percentage of syllables correctly repeated from the target sentences will be computed for each contrast, Unison vs. Solo and Metrical vs. Conversational, capturing all 4 conditions in the 2x2 design (Unison Metrical, Unison Conversational, Solo Metrical, Solo Conversational).
A protocol will be used to score syllables for correctness.
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1 day study visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Syllable Offset From Model
Time Frame: 1 day study visit
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Of the syllables attempted by the participant, the mean offset from the corresponding target syllable in the model is computed for each syllable for each participant using the formula (p - d) - s, where p is the timing of voicing onset in the participant response, d is the timing of voicing onset in the model, and s is the line delay in the audio equipment. Means are computed for each participant and each condition. Note this measure can only be computed in the Unison conditions (Unison Metrical and Unison Conversational), since the Solo conditions do not have a simultaneous spoken model to which the participant is trying to align their speech. |
1 day study visit
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Collaborators and Investigators
Investigators
- Principal Investigator: Lauryn Zipse, PhD, MGH IHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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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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Maya HenryNational Institutes of Health (NIH); National Institute on Aging (NIA)RecruitingSemantic Dementia | Logopenic Progressive Aphasia | Nonfluent Aphasia, Progressive | Logopenic Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive Aphasia (svPPA) | Nonfluent Variant Primary Progressive Aphasia (nfvPPA) | Progressive Aphasia | Logopenic Progressive Aphasia... and other conditionsUnited States
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University of Texas at AustinNational Institute on Deafness and Other Communication Disorders (NIDCD)Enrolling by invitationPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
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