Parkinson DiseaseNCT05754086
A Multidimensional Study on Articulation Deficits in Parkinsons Disease
An observational study of Parkinson Disease and Dysarthria, Hypokinetic, run by Florida State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Dysarthria, Hypokinetic
- What is being tested?
- Clear Speech and Less Clear Speech
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2021to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Not within the age limits
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32309
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Dysarthria, Hypokinetic
- Being tested
- Clear Speech, Less Clear Speech
- Medical subject headings
- Parkinson Disease, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear SpeechBehavioural
This behavioral modification asks participants to speak more clearly, as if they were "speaking to someone with a hearing loss".
Less Clear SpeechBehavioural
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."
| Study group | Role | What they receive |
|---|---|---|
| Parkinsons (PD) Group | This cohort includes individuals who have been diagnosed with Parkinson's disease. Receives: Behavioral: Clear Speech; Behavioral: Less Clear Speech | |
| Neurotypical (NT) Group | This group consists of age-matched control participants. They are neurologically healthy and do not have any neurological diagnoses. Receives: Behavioral: Clear Speech; Behavioral: Less Clear Speech |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vowel Space Area
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.
Measured: Baseline
F2 Slope
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."
Measured: Baseline
Tongue and Jaw Speed
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.
Measured: Baseline
Acoustic Distance
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.
Measured: Baseline
Tongue and Jaw Distance
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start9 Sep 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Yunjung Kim, Florida State University
- Investigators
- Yunjung Kim, Ph.D., Study chair, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754086
- Sponsor's protocol ID
- STUDY00002525
- Other IDs
- F31DC020121
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The analytic data and code will be shared to the open science framework (OSF) upon completion of the project, expected July 2023.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidimensional Study on Articulation Deficits in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05754086
- Acronym / sponsor ID
- STUDY00002525
- Conditions
- Parkinson Disease, Dysarthria, Hypokinetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinsons (PD) Group | – | Behavioral: Clear Speech, Behavioral: Less Clear SpeechThis cohort includes individuals who have been diagnosed with Parkinson's disease. |
| Neurotypical (NT) Group | – | Behavioral: Clear Speech, Behavioral: Less Clear SpeechThis group consists of age-matched control participants. They are neurologically healthy and do not have any neurological diagnoses. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not within the age limits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clear SpeechThis behavioral modification asks participants to speak more clearly, as if they were "speaking to someone with a hearing loss". | Behavioural | Neurotypical (NT) Group, Parkinsons (PD) Group |
| Less Clear SpeechThis 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." | Behavioural | Neurotypical (NT) Group, Parkinsons (PD) Group |
Primary outcome
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.
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."
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: Yes. The analytic data and code will be shared to the open science framework (OSF) upon completion of the project, expected July 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunjung Kim, Ph.D. study chair
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dysarthria, Hypokinetic, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vowel Space Area (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.