- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05909163
Spoken Discourse Biomarker of PD Cognitive Impairment
Spoken Language Biomarker of Cognitive Impairment in PD
Study Overview
Status
Conditions
Detailed Description
Aim 1 will characterize PD-MCI (Parkinson's disease mild cognitive impairment), PDN (Parkinson's disease without cognitive impairment), and HA (healthy adult) spoken discourse, cognitive, and motor speech profiles. Phase 2 biomarker development requires robustly characterized cohorts in which to test candidate biomarkers. Using a standardized battery of cognitive, language, and motor speech tests PD participants will be assigned to PD-MCI (single/multi-domain) or PDN groups. The investigators propose collecting spoken discourse samples using standardized elicitation protocols. The same tasks will be extracted from the extant HA database. Researchers will transcribe, code, and analyze discourse samples. Group differences (including sub-analyses for single and multi-domain MCI subtypes), elicitation stimuli effects, and group x stimuli interactions will be examined using multivariate and mixed-design ANOVA procedures.
Aim 2 will develop and evaluate the classification accuracy of an optimally weighted discourse classification function for PD-MCI and PDN. The investigators propose using discriminant function analysis to identify an optimized composite variable that best predicts PD-MCI, PDN, and HA group membership. Sensitivity/specificity analyses, positive/negative predictive values, and receiver operating characteristic curves will be used to evaluate the discourse classification function properties.
The primary endpoint is an optimally weighted discourse function that can classify PD-MCI with > 80% sensitivity/specificity.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Evanston, Illinois, United States, 60201
- Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Only individuals with PD will be newly recruited and enrolled as part of the study. Healthy adult data will be extracted from extant databases (publicly available) from NIH-funded studies.
Inclusion Criteria Person with Parkinson's disease without cognitive impairment
- Age 50-90 years
- Diagnosis of idiopathic Parkinson's disease (UK Brain Bank criteria) made by a movement disorders specialist
- Under the care of a movement disorders specialist for a minimum of 1-year duration
- Native monolingual English speaker
- Hoehn & Yahr score between 1.5 and 4
- Grade 10 education, or higher
- Sufficient vision and hearing (aided or unaided) for all experiment tasks
- Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than or equal to 25
- No subjective complaints of cognitive difficulty or word finding issues
Inclusion Criteria Person with Parkinson's disease mild cognitive impairment
- Age 50-90 years
- Diagnosis of idiopathic Parkinson's disease (UK Brain Bank criteria) made by a movement disorders specialist
- Under the care of a movement disorders specialist for a minimum of 1-year duration
- Native monolingual English speaker
- Hoehn & Yahr score between 1.5 and 4
- Grade 10 education, or higher
- Sufficient vision and hearing (aided or unaided) for all experiment tasks
- Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than or equal to 17
- Subjective complaints of cognitive difficulty or word finding issues, without significant impact on activities of daily living
Inclusion Healthy Adults (from extant data base - no new recruiting)
- Age 50-90 years
- Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than or equal to 26
- Native monolingual English speaker
- Grade 10 education, or higher
- Sufficient vision and hearing (aided or unaided) for all experiment tasks
Exclusion Criteria:
Exclusion Criteria Neurological injury or disease (other than PD for the PD cohort)
- History of unmanaged or untreated depression or major psychiatric illness
- History of deep brain stimulation surgery (DBS)
- Diagnosis of Dementia with Lewy Bodies
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pakinson's disease without cognitive impairment
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Pakinson's disease with cognitive impairment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discourse Composite Variable
Time Frame: baseline
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Weighted variable comprised of discourse features extracted from spoken discourse samples across productivity, lexical retrieval, verbal fluency, syntax complexity, grammatical accuracy, narrative coherence, correct information units, and main event accuracy.
Raw data from each measure are multiplied by a specified weight and summed to generate a single composite discourse score.
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Words per minute
Time Frame: baseline
|
Number of total words ÷ Participant speaking time in minutes
|
baseline
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Correct information units (CIUs)
Time Frame: baseline
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Number of words intelligible in context and accurate, relevant, and informative about the picture content (Brookshire & Nicholas, 1994; Nicholas & Brookshire, 1993)
|
baseline
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% CIUs
Time Frame: baseline
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CIUs ÷ number of words (Brookshire & Nicholas, 1994; Nicholas & Brookshire, 1993) × 100
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baseline
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CIUs/min
Time Frame: baseline
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CIUs ÷ Participant speaking time in minutes (Brookshire & Nicholas, 1994; Nicholas & Brookshire, 1993)
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baseline
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% Main Events
Time Frame: baseline
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Proportion of correct narrative main events (Capilouto et al., 2005)
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baseline
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Moving-average type-token ratio (MATTR)
Time Frame: baseline
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SALT-generated moving-average ratio of different words : total words (SALT Inc., 2017").
Window size = 23 words, based on the number of words in smallest discourse sample (Roberts & Post, 2018)
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baseline
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Mean length of utterance (MLU)
Time Frame: baseline
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Mean length of utterance in words for intelligible, complete, verbal, task-relevant utterances (SALT Inc., 2017)
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baseline
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% Grammatical
Time Frame: baseline
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Number of content units without lexical selection or grammar rule violations (Thompson et al., 1995, 2012) ÷ Total intelligible, complete, verbal, task-relevant utterances × 100
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baseline
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Subordination index (SI)
Time Frame: baseline
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Subordination index composite score.
The ratio of total number of subject + Predicate clauses : total number of content units (SALT Software LLC, 2018b)
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baseline
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Number of clauses/content units
Time Frame: baseline
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Number of clauses per content units (based on the count of main verbs)
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baseline
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Word-level dysfluencies/content units
Time Frame: baseline
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Total number of word, syllable, and sound repetitions plus the total number of initial, middle, and final sound prolongations (SALT Software LLC, 2018a) ÷ Total utterances
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baseline
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Number of pauses/content units
Time Frame: baseline
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Number of pauses >1.5 s ÷ Total utterances
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baseline
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Percent maze words/total words
Time Frame: baseline
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Maze words (i.e., filled pauses, false starts, reformulations, and interjections) ÷ Maze words + non-maze words
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baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discourse Global Coherence
Time Frame: baseline
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Each utterance is rated on a scale of 1-4 judging the relation of each sentence to the overall topic.
'4' reflects that the utterance is overtly related to the stimulus as defined by mention of actors, actions, and/or objects present in the stimulus, which are of significant importance to the main details of the stimulus.
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baseline
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Discourse Local Coherence
Time Frame: baseline
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Each utterance is rated on a scale of 1-5 judging the relation of adjacent sentences to each other.
'5' reflects that the utterance is in relation to continuation, elaboration, repetition, subordination or coordination of ideas from the preceding utterance.
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baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.
- Brookshire RH, Nicholas LE. Speech sample size and test-retest stability of connected speech measures for adults with aphasia. J Speech Hear Res. 1994 Apr;37(2):399-407. doi: 10.1044/jshr.3702.399.
- Capilouto G, Wright HH, Wagovich SA. CIU and main event analyses of the structured discourse of older and younger adults. J Commun Disord. 2005 Nov-Dec;38(6):431-44. doi: 10.1016/j.jcomdis.2005.03.005. Epub 2005 Apr 26.
- Roberts A, Post D. Information Content and Efficiency in the Spoken Discourse of Individuals With Parkinson's Disease. J Speech Lang Hear Res. 2018 Sep 19;61(9):2259-2274. doi: 10.1044/2018_JSLHR-L-17-0338.
- Thompson CK, Cho S, Hsu CJ, Wieneke C, Rademaker A, Weitner BB, Mesulam MM, Weintraub S. Dissociations Between Fluency And Agrammatism In Primary Progressive Aphasia. Aphasiology. 2012;26(1):20-43. doi: 10.1080/02687038.2011.584691.
- Thompson, C. K., Shapiro, L. P., Li, L., & Schendel, L. (1995). Analysis of verbs and verb-argument structure: A method for quantification of aphasic language production. Clinical Aphasiology, 23, 121-140.
- Harris Wright, H., Koutsoftas, A., Fergadiotis, G., & Capilouto, G. (2010). Coherence in Stories Told by Adults With Aphasia.
- Wright HH, Capilouto GJ. Considering a multi-level approach to understanding maintenance of global coherence in adults with aphasia. Aphasiology. 2012 Jan 1;26(5):656-672. doi: 10.1080/02687038.2012.676855. Epub 2012 May 10.
- Glosser G, Deser T. Patterns of discourse production among neurological patients with fluent language disorders. Brain Lang. 1991 Jan;40(1):67-88. doi: 10.1016/0093-934x(91)90117-j.
- Van Leer E, Turkstra L. The effect of elicitation task on discourse coherence and cohesion in adolescents with brain injury. J Commun Disord. 1999 Sep-Oct;32(5):327-48; quiz 348-9. doi: 10.1016/s0021-9924(99)00008-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00209602
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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