Amyotrophic Lateral SclerosisNCT03613038
A Systematic Investigation of Phonetic Complexity Effects on Articulatory Motor Performance in Progressive Dysarthria
A study testing Phonetic complexity effects on speech motor performance in people with Amyotrophic Lateral Sclerosis and Parkinson Disease, run by University of Missouri-Columbia at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Parkinson Disease
- What is being tested?
- Phonetic complexity effects on speech motor performance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2017to 28 Feb 2022
- Phase
- Interventional
- 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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Missouri-Columbia
Columbia, Missouri, 65211
University of Kansas Medical Center
Fairway, Kansas, 66205
About this study
Official title: 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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis, Parkinson Disease
- Being tested
- Phonetic complexity effects on speech motor performance
- Keywords
- Dysarthria, Speech motor performance, Speech motor control, Speech kinematics
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Parkinson Disease, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phonetic complexity effects on speech motor performanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Phonetic complexity effects on speech motor performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 months after enrollment
Duration
Word duration (seconds) is the time between onset and offset of movement for each word.
Measured: 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.
Measured: 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.
Measured: Up to 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start15 Jul 2017
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Mili Kuruvilla, University of Missouri-Columbia
- Investigators
- Mili Kuruvilla-Dugdale, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613038
- Sponsor's protocol ID
- 1209643
- Other IDs
- 1R15DC016383-01
- Status last verified
- May 2022
- First submitted
- 10 Jul 2018
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Communication and Cognitive Impairments in Neurodegenerative Disorders
- ClinicalTrials.gov ID
- NCT03613038
- Acronym / sponsor ID
- 1209643
- Conditions
- Amyotrophic Lateral Sclerosis, Parkinson Disease
- Keywords
- Dysarthria, Speech motor performance, Speech motor control, Speech kinematics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 2 Aug 2018 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phonetic complexity effects | Other | Behavioral: Phonetic complexity effects on speech motor performanceConduct 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. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Phonetic complexity effects on speech motor performanceUse 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. | Behavioural | Phonetic complexity effects |
Primary outcome
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.
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.
Duration
Time frame: Up to 3 months after enrollment
Word duration (seconds) is the time between onset and offset of movement for each word.
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.
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.
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 17 May 2022.
- Individual participant dataSharing planned: Yes. 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.
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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.
Mili Kuruvilla-Dugdale, PhD principal investigator
University of Missouri-Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonetic complexity effects on speech motor performance in people with Amyotrophic Lateral Sclerosis and Parkinson Disease, run by University of Missouri-Columbia at 2 sites 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 7 inclusion and 2 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 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Peak movement speed (time frame: Up to 3 months after enrollment). 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 17 May 2022.