- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613038
A Systematic Investigation of Phonetic Complexity Effects on Articulatory Motor Performance in Progressive Dysarthria
May 16, 2022 updated by: Mili Kuruvilla, University of Missouri-Columbia
Understanding Communication and Cognitive Impairments in Neurodegenerative Disorders
The goal is to improve the fundamental knowledge about articulatory motor performance in people with Lou Gehrig's disease (also known as ALS) and Parkinson's disease (PD), in order to develop more sensitive assessments for progressive speech loss, which may lead to the improved timing of speech therapies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The long-term goal is to optimize dysarthria assessment by improving the early detection and tracking of articulatory performance in progressive dysarthrias.
The short-term goal of the proposed cross-sectional study is to focus on ALS and PD and quantify articulatory kinematic performance as a function of phonetic complexity, which is experimentally manipulated based on theoretical principles of speech motor development.
The research strategy is to use 3D electromagnetic articulography to examine phonetic complexity effects of single word stimuli at the articulatory kinematic level in 15 talkers each with preclinical, mild, and moderate dysarthria, relative to 45 controls.
The central hypothesis is that as dysarthria severity increases the discrepancy in articulatory performance, indexed by movement speed, distance, coordination, and variability, between people with dysarthria and typical controls will significantly increase at a lower phonetic complexity level.
Study Type
Interventional
Enrollment (Actual)
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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Kansas
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Fairway, Kansas, United States, 66205
- University of Kansas Medical Center
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Missouri
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Columbia, Missouri, United States, 65211
- University of Missouri-Columbia
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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
19 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- May or may not have a neurological impairment.
- Age range of 19-90 years.
- Male or female.
- Provide written consent before any study specific procedures are performed.
- Have ability to comply with basic instructions.
- Monolingual English speaker.
- Have ability to partake in a 90 minute data collection.
Exclusion Criteria:
- Any speech, language, cognition, or hearing impairment prior to diagnosis of a neurodegenerative disease.
- Anyone not appropriate for study participation, as deemed by the principal investigator.
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 |
---|---|
Other: Phonetic complexity effects
Conduct a comprehensive kinematic assessment using state-of-the art 3D speech tracking technology on individuals with ALS and PD as well as healthy talkers to identify articulatory motor disturbances as a function of phonetic complexity and dysarthria severity.
Phonetic complexity will be experimentally manipulated using the consonant and vowel complexity classification system proposed by Kent (1992) that takes into account the underlying articulatory motor adjustments required to produce various speech sounds.
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Use of 3D electromagnetic articulography to examine phonetic complexity effects of single word stimuli at the articulatory kinematic level in talkers each with preclinical, mild, and moderate dysarthria, relative to healthy controls.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak movement speed
Time Frame: Up to 3 months after enrollment
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Peak speed (millimeters/second) for each articulatory marker is the maximum value of the first-order derivative of each marker's Euclidean distance time-history.
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Up to 3 months after enrollment
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Range of movement
Time Frame: Up to 3 months after enrollment
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The convex hull represents the smallest convex set containing all the points in the 3D motion path.
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Up to 3 months after enrollment
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Duration
Time Frame: Up to 3 months after enrollment
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Word duration (seconds) is the time between onset and offset of movement for each word.
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Up to 3 months after enrollment
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Spatiotemporal movement variability (STI)
Time Frame: Up to 3 months after enrollment
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STI is the most widely used metric to capture movement pattern variability during speech.
To determine STI, the pattern of articulatory movements and the variability of that pattern over several repetitions of an utterance are examined.
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Up to 3 months after enrollment
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Inter-articulator coordination
Time Frame: Up to 3 months after enrollment
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Spatiotemporal coupling relations between articulators will be derived from vertical movements of the articulators using a covariance measure.
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Up to 3 months after enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mili Kuruvilla-Dugdale, PhD, University of Missouri-Columbia
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)
July 15, 2017
Primary Completion (Actual)
February 28, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
July 10, 2018
First Submitted That Met QC Criteria
July 27, 2018
First Posted (Actual)
August 2, 2018
Study Record Updates
Last Update Posted (Actual)
May 17, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neuromuscular Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Articulation Disorders
- Parkinson Disease
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Dysarthria
Other Study ID Numbers
- 1209643
- 1R15DC016383-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The data collected during this study, especially from people with ALS, cannot be easily duplicated so it will be readily shared with other researchers conducting motor speech research.
In addition, few investigators have access to tongue tracking technology; therefore, making the tongue kinematic data available will allow other investigators to answer pertinent questions related to speech decline in progressive dysarthrias.
Both the raw data and processed data will be made available to interested investigators but will be devoid of identifiers in order to protect the privacy of the participants.
Data documentation such as descriptors and units will also be shared to prevent misinterpretation or confusion.
Besides the data itself, the PI is willing to share the stimuli as requested by other investigators.
IPD Sharing Time Frame
Data will be ensured as soon as the study starts and even after the study ends.
IPD Sharing Access Criteria
Data will only be shared for research purposes.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
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.
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