An interventional study of Phonetic complexity effects on speech motor performance in Amyotrophic Lateral Sclerosis and Parkinson Disease, sponsored by University of Missouri-Columbia. Completed at 2 sites in United States. Open to participants aged 19 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Basic science
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.
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.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's enrollment of 100 is above the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.
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Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: Up to 3 months after enrollment
Duration
Word duration (seconds) is the time between onset and offset of movement for each word.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 months after enrollment
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Feb 2022, 55 months.
Of 134 non-industry interventional studies with no phase under Amyotrophic Lateral Sclerosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's 55 months is above that.
Counting every sponsor, half of 154 studies reached it within 35 months; a quarter within 23 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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