Clinical trial NCT05909163: Spoken Discourse Biomarker of PD Cognitive Impairment
Official title: Spoken Language Biomarker of Cognitive Impairment in PD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The purpose of this study is to identify unique profiles of speech and language changes that distinguish individuals with Parkinson's disease from adults without Parkinson's disease and individuals with Parkinson's disease with cognitive (e.g., memory, thinking skills) impairment from those without cognitive impairment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Discourse Composite Variable
timeFrame: baseline
Secondary outcomes:
measure: Words per minute
timeFrame: baseline
measure: Correct information units (CIUs)
timeFrame: baseline
measure: % CIUs
timeFrame: baseline
measure: CIUs/min
timeFrame: baseline
measure: % Main Events
timeFrame: baseline
measure: Moving-average type-token ratio (MATTR)
timeFrame: baseline
measure: Mean length of utterance (MLU)
timeFrame: baseline
measure: % Grammatical
timeFrame: baseline
measure: Subordination index (SI)
timeFrame: baseline
measure: Number of clauses/content units
timeFrame: baseline
measure: Word-level dysfluencies/content units
timeFrame: baseline
measure: Number of pauses/content units
timeFrame: baseline
measure: Percent maze words/total words
timeFrame: baseline
Other outcomes:
measure: Discourse Global Coherence
timeFrame: baseline
measure: Discourse Local Coherence
timeFrame: baseline
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
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