Spoken Discourse Biomarker of PD Cognitive Impairment
- Conditions
- Parkinson Disease
- Registration Number
- NCT05909163
- Lead Sponsor
- Northwestern University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
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 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Discourse Composite Variable baseline 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.
- Secondary Outcome Measures
Name Time Method Percent maze words/total words baseline Maze words (i.e., filled pauses, false starts, reformulations, and interjections) ÷ Maze words + non-maze words
Correct information units (CIUs) baseline Number of words intelligible in context and accurate, relevant, and informative about the picture content (Brookshire \& Nicholas, 1994; Nicholas \& Brookshire, 1993)
CIUs/min baseline CIUs ÷ Participant speaking time in minutes (Brookshire \& Nicholas, 1994; Nicholas \& Brookshire, 1993)
% Main Events baseline Proportion of correct narrative main events (Capilouto et al., 2005)
Moving-average type-token ratio (MATTR) baseline 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)
% Grammatical baseline Number of content units without lexical selection or grammar rule violations (Thompson et al., 1995, 2012) ÷ Total intelligible, complete, verbal, task-relevant utterances × 100
Words per minute baseline Number of total words ÷ Participant speaking time in minutes
% CIUs baseline CIUs ÷ number of words (Brookshire \& Nicholas, 1994; Nicholas \& Brookshire, 1993) × 100
Mean length of utterance (MLU) baseline Mean length of utterance in words for intelligible, complete, verbal, task-relevant utterances (SALT Inc., 2017)
Number of clauses/content units baseline Number of clauses per content units (based on the count of main verbs)
Subordination index (SI) baseline Subordination index composite score. The ratio of total number of subject + Predicate clauses : total number of content units (SALT Software LLC, 2018b)
Number of pauses/content units baseline Number of pauses \>1.5 s ÷ Total utterances
Word-level dysfluencies/content units baseline 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
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Evanston, Illinois, United States