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A Systematic Investigation of Phonetic Complexity Effects on Articulatory Motor Performance in Progressive Dysarthria

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ClinicalTrials.gov Identifier: NCT03613038
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Mili Kuruvilla, University of Missouri-Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Parkinson Disease Behavioral: Phonetic complexity effects on speech motor performance Not Applicable

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.

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Study Type : Interventional
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Two groups of participants i.e., participants with ALS or PD and healthy controls will be asked to repeat sentences that have target words with varying phonetic complexity.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Understanding Communication and Cognitive Impairments in Neurodegenerative Disorders
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : July 14, 2020


Arm Intervention/treatment
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.
Behavioral: Phonetic complexity effects on speech motor performance
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.




Primary Outcome Measures :
  1. Peak movement speed [ Time Frame: Up to 3 months after enrollment ]
    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.

  2. Range of movement [ Time Frame: Up to 3 months after enrollment ]
    The convex hull represents the smallest convex set containing all the points in the 3D motion path.

  3. Duration [ Time Frame: Up to 3 months after enrollment ]
    Word duration (seconds) is the time between onset and offset of movement for each word.

  4. Spatiotemporal movement variability (STI) [ Time Frame: Up to 3 months after enrollment ]
    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.

  5. Inter-articulator coordination [ Time Frame: Up to 3 months after enrollment ]
    Spatiotemporal coupling relations between articulators will be derived from vertical movements of the articulators using a covariance measure.



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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. May or may not have a neurological impairment.
  2. Age range of 19-90 years.
  3. Male or female.
  4. Provide written consent before any study specific procedures are performed.
  5. Have ability to comply with basic instructions.
  6. Monolingual English speaker.
  7. Have ability to partake in a 90 minute data collection.

Exclusion Criteria:

  1. Any speech, language, cognition, or hearing impairment prior to diagnosis of a neurodegenerative disease.
  2. Anyone not appropriate for study participation, as deemed by the principal investigator.

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): NCT03613038


Contacts
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Contact: Mili Kuruvilla-Dugdale 573-882-2910 kuruvillam@missouri.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Fairway, Kansas, United States, 66205
Contact: Mili Kuruvilla, PhD    573-882-2910    kuruvillam@missouri.edu   
Principal Investigator: Richard Barohn, MD         
United States, Missouri
University of Missouri-Columbia Recruiting
Columbia, Missouri, United States, 65211
Contact: Mili Kuruvilla-Dugdale, PhD    573-882-2910    kuruvillam@missouri.edu   
Principal Investigator: Mili Kuruvilla-Dugdale, PhD         
Sponsors and Collaborators
University of Missouri-Columbia
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Mili Kuruvilla-Dugdale, PhD University of Missouri-Columbia

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Responsible Party: Mili Kuruvilla, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03613038     History of Changes
Other Study ID Numbers: 1209643
1R15DC016383-01 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be ensured as soon as the study starts and even after the study ends.
Access Criteria: Data will only be shared for research purposes.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mili Kuruvilla, University of Missouri-Columbia:
Dysarthria
Speech motor performance
Speech motor control
Speech kinematics
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Parkinson Disease
Dysarthria
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neuromuscular Diseases
Spinal Cord Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Articulation Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms