A Multidimensional Study on Articulation Deficits in Parkinsons Disease

August 23, 2024 updated by: Yunjung Kim, Florida State University

A Multidimensional Study on Articulation Deficits in Parkinson's Disease

Articulatory deficits are present in most speakers with dysarthria, which negatively impacts their speech intelligibility, yet little is known about the relationship between articulatory movement and speech intelligibility. This study will examine the relationship between articulation measures, both acoustic and kinematic, and their relationship to perceptual measures (i.e., speech intelligibility and articulation ratings) in 30 individuals with dysarthria secondary to Parkinson's disease and 30 neurologically healthy adults of the same age. The findings will have implications for behavioral management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dysarthria is a motor speech disorder that affects individuals with various etiologies. Parkinson's disease (PD) alone affects nearly one million individuals in the U.S., with dysarthria developing in approximately 90% of these individuals within the first two years of onset. The dysarthria associated with PD is characterized by reduced movement, which has been supported by findings of reduced lip, tongue, and jaw movement in speakers with PD. However, it remains unclear if hypokinetic dysarthria causes a global reduction across all articulators, or if specific articulators are disproportionally affected by the disease. Further, it is not fully understood what factors contribute to speech intelligibility. Specifically, little is known about the articulatory-kinematic correlates of speech intelligibility. This missing link is vital to understand, as articulation deficits are a universal characteristic of dysarthria, regardless of etiology. The proposed study provides a linked investigation of kinematic, acoustic, and perceptual characteristics in speakers with PD and neurologically healthy speakers.

This research aims to (1) examine the perceptual, acoustic, and articulator-specific movement deficits in speakers with PD and (2) understand the relationship between articulatory movement and measures of speech perception. Specific Aim 1 will examine the group differences between speakers with PD and neurologically healthy speakers using perceptual, acoustic, and articulator-specific kinematic measures. The investigators hypothesize the perceptual, acoustic, and tongue-related kinematic measures will differentiate individuals with PD from neurologically healthy speakers. Specific Aim 2 will model speech intelligibility (Specific Aim 2a) and ratings of articulatory precision (Specific Aim 2b) using selected acoustic and kinematic measurements. The investigators hypothesize that the acoustic measures will be stronger predictors of speech intelligibility than the kinematic measures, as they are both derived from the speech signal. Further, the investigators hypothesize the selected kinematic measures may demonstrate a stronger relationship to articulation ratings than speech intelligibility. This study is a requisite step toward our long-term goal of advancing dysarthria management strategies. The primary outcome will be explanatory models that identify acoustic and articulatory correlates of speech intelligibility and articulatory precision. This study has important implications for developing articulator-specific dysarthria management strategies to supplement universal dysarthria management strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32309
        • Florida State University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All participants will be recruited via convenient sampling from Tallahassee, FL, and the local community. For the neurologically healthy control speakers, flyers will be posted at local coffee shops, community samples, and via word of mouth. For the Parkinson's participants, flyers will be posted at hospitals, health clinics, and gyms.

Description

Inclusion Criteria:

  • neurological diagnosis of PD (for the PD group only)
  • diagnosis of dysarthria (for the PD group only)
  • native English speaker
  • no evidence of cognitive impairment, as indicated by a score above 26 on the Montreal Cognitive Assessment
  • able to read a paragraph in 19-point font

Exclusion Criteria:

  • Not within the age limits

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Parkinsons (PD) Group
This cohort includes individuals who have been diagnosed with Parkinson's disease.
Behavioral: Clear Speech
This behavioral modification asks participants to speak more clearly, as if they were "speaking to someone with a hearing loss".
Behavioral: Less Clear Speech
This behavioral modification asks participants to speak less clearly, as if they were "in a room with many people and they were mumbling something to the person next to them that they didn't want other people in the room to hear."
Neurotypical (NT) Group
This group consists of age-matched control participants. They are neurologically healthy and do not have any neurological diagnoses.
Behavioral: Clear Speech
This behavioral modification asks participants to speak more clearly, as if they were "speaking to someone with a hearing loss".
Behavioral: Less Clear Speech
This behavioral modification asks participants to speak less clearly, as if they were "in a room with many people and they were mumbling something to the person next to them that they didn't want other people in the room to hear."

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vowel Space Area
Time Frame: Baseline
Vowel space area is a measure of the planar area among the four corner vowels /i/, /ae/, /a/, and /u/. It is calculated using the first and second formant resonant frequencies obtained from the acoustic signal, using the software PRAAT.
Baseline
Tongue and Jaw Speed
Time Frame: Baseline
This is measured as the tongue and jaw speed during the diphthong in "Buy". Specifically, this will be calculated as tongue/jaw movement (measured in mm), divided by movement duration (measured in ms). The tongue and jaw movement will be collected using the electromagnetic articulography (EMA) device used in this study.
Baseline
Acoustic Distance
Time Frame: Baseline
This is measured as the Euclidean distance between the second formant frequency (F2) onset and offset of the diphthong in "Buy" in an F1-F2 (first and second formant frequency) space. Measured in Hz.
Baseline
Tongue and Jaw Distance
Time Frame: Baseline
This is measured as the Euclidean distance between the tongue and jaw onset and offset of the diphthong in "Buy" in a two-dimensional space.The tongue and jaw movement will be collected using the electromagnetic articulography (EMA) device used in this study.
Baseline
F2 Slope
Time Frame: Baseline
Second formant frequency (F2) slope is measured as the rate of F2 change during the diphthong in "Buy." To calculate this measure, first the investigators will obtain the extent of F2 change (max F2 - min F2) from the diphthong "Buy." Then this F2 change is divided by the duration of the diphthong "Buy."
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yunjung Kim, Ph.D., Florida State University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002525
  • F31DC020121 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The analytic data and code will be shared to the open science framework (OSF) upon completion of the project, expected July 2023.

IPD Sharing Time Frame

Analytic data and code will be made available in July 2023.

IPD Sharing Access Criteria

Upon publication to the open science framework (OSF) project page, anyone will have access to the analytic data and code.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

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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