Northwestern University
Evanston, Illinois, 60201, United States
NCT Number: NCT05909163
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.
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Notify Me50 year–90 year
All sexes
Observational
Evanston, Illinois, 60201, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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)
Time frame: 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.
Time frame: baseline
Number of total words ÷ Participant speaking time in minutes
Time frame: baseline
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 ÷ number of words (Brookshire & Nicholas, 1994; Nicholas & Brookshire, 1993) × 100
Time frame: baseline
CIUs ÷ Participant speaking time in minutes (Brookshire & Nicholas, 1994; Nicholas & Brookshire, 1993)
Time frame: baseline
Proportion of correct narrative main events (Capilouto et al., 2005)
Time frame: 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)
Time frame: baseline
Mean length of utterance in words for intelligible, complete, verbal, task-relevant utterances (SALT Inc., 2017)
Time frame: 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
Time frame: baseline
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 per content units (based on the count of main verbs)
Time frame: 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
Time frame: baseline
Number of pauses >1.5 s ÷ Total utterances
Time frame: baseline
Maze words (i.e., filled pauses, false starts, reformulations, and interjections) ÷ Maze words + non-maze words
Time frame: baseline
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
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.
Northwestern University
Other
Spoken Language Biomarker of Cognitive Impairment in PD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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