An observational study in Parkinson Disease, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by Northwestern University · Observational
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 140 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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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.
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
Inclusion Criteria Person with Parkinson's disease mild cognitive impairment
Inclusion Healthy Adults (from extant data base - no new recruiting)
Exclusion Criteria:
Exclusion Criteria Neurological injury or disease (other than PD for the PD cohort)
* 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
* 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
Discourse Composite Variable
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.
Time frame: baseline
Words per minute
Number of total words ÷ Participant speaking time in minutes
Time frame: baseline
Correct information units (CIUs)
Number of words intelligible in context and accurate, relevant, and informative about the picture content (Brookshire \& Nicholas, 1994; Nicholas \& Brookshire, 1993)
Time frame: baseline
% CIUs
CIUs ÷ number of words (Brookshire \& Nicholas, 1994; Nicholas \& Brookshire, 1993) × 100
Time frame: baseline
CIUs/min
CIUs ÷ Participant speaking time in minutes (Brookshire \& Nicholas, 1994; Nicholas \& Brookshire, 1993)
Time frame: baseline
% Main Events
Proportion of correct narrative main events (Capilouto et al., 2005)
Time frame: baseline
Moving-average type-token ratio (MATTR)
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)
Time frame: baseline
Mean length of utterance (MLU)
Mean length of utterance in words for intelligible, complete, verbal, task-relevant utterances (SALT Inc., 2017)
Time frame: baseline
% Grammatical
Number of content units without lexical selection or grammar rule violations (Thompson et al., 1995, 2012) ÷ Total intelligible, complete, verbal, task-relevant utterances × 100
Time frame: baseline
Subordination index (SI)
Subordination index composite score. The ratio of total number of subject + Predicate clauses : total number of content units (SALT Software LLC, 2018b)
Time frame: baseline
Number of clauses/content units
Number of clauses per content units (based on the count of main verbs)
Time frame: baseline
Word-level dysfluencies/content units
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
Time frame: baseline
Number of pauses/content units
Number of pauses \>1.5 s ÷ Total utterances
Time frame: baseline
Percent maze words/total words
Maze words (i.e., filled pauses, false starts, reformulations, and interjections) ÷ Maze words + non-maze words
Time frame: baseline
Discourse Global Coherence
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.
Time frame: baseline
Discourse Local Coherence
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.
Time frame: baseline
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