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Completed

NCT Number: NCT05909163

Spoken Discourse Biomarker of PD Cognitive Impairment

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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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

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

  • 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

Treatment and study plan

Primary outcomes

  1. Discourse Composite Variable

    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.

Secondary outcomes

  1. Words per minute

    Time frame: baseline

    Number of total words ÷ Participant speaking time in minutes

  2. Correct information units (CIUs)

    Time frame: baseline

    Number of words intelligible in context and accurate, relevant, and informative about the picture content (Brookshire & Nicholas, 1994; Nicholas & Brookshire, 1993)

  3. % CIUs

    Time frame: baseline

    CIUs ÷ number of words (Brookshire & Nicholas, 1994; Nicholas & Brookshire, 1993) × 100

  4. CIUs/min

    Time frame: baseline

    CIUs ÷ Participant speaking time in minutes (Brookshire & Nicholas, 1994; Nicholas & Brookshire, 1993)

  5. % Main Events

    Time frame: baseline

    Proportion of correct narrative main events (Capilouto et al., 2005)

  6. Moving-average type-token ratio (MATTR)

    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)

  7. Mean length of utterance (MLU)

    Time frame: baseline

    Mean length of utterance in words for intelligible, complete, verbal, task-relevant utterances (SALT Inc., 2017)

  8. % Grammatical

    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

  9. Subordination index (SI)

    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)

  10. Number of clauses/content units

    Time frame: baseline

    Number of clauses per content units (based on the count of main verbs)

  11. Word-level dysfluencies/content units

    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

  12. Number of pauses/content units

    Time frame: baseline

    Number of pauses >1.5 s ÷ Total utterances

  13. Percent maze words/total words

    Time frame: baseline

    Maze words (i.e., filled pauses, false starts, reformulations, and interjections) ÷ Maze words + non-maze words

Other outcomes

  1. Discourse Global Coherence

    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.

  2. Discourse Local Coherence

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Spoken Language Biomarker of Cognitive Impairment in PD

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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