NCT03613038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

4.6 years

First QC Date

July 10, 2018

Last Update Submit

May 16, 2022

Conditions

Keywords

DysarthriaSpeech motor performanceSpeech motor controlSpeech kinematics

Outcome Measures

Primary Outcomes (5)

  • Peak movement speed

    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.

    Up to 3 months after enrollment

  • Range of movement

    The convex hull represents the smallest convex set containing all the points in the 3D motion path.

    Up to 3 months after enrollment

  • Duration

    Word duration (seconds) is the time between onset and offset of movement for each word.

    Up to 3 months after enrollment

  • Spatiotemporal movement variability (STI)

    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.

    Up to 3 months after enrollment

  • Inter-articulator coordination

    Spatiotemporal coupling relations between articulators will be derived from vertical movements of the articulators using a covariance measure.

    Up to 3 months after enrollment

Study Arms (1)

Phonetic complexity effects

OTHER

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

Interventions

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.

Phonetic complexity effects

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Fairway, Kansas, 66205, United States

Location

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisParkinson DiseaseDysarthria

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesMovement DisordersSynucleinopathiesArticulation DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mili Kuruvilla-Dugdale, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 10, 2018

First Posted

August 2, 2018

Study Start

July 15, 2017

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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.

Locations