NCT05909163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

4 years

First QC Date

October 21, 2021

Last Update Submit

June 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Secondary Outcomes (13)

  • Words per minute

    baseline

  • Correct information units (CIUs)

    baseline

  • % CIUs

    baseline

  • CIUs/min

    baseline

  • % Main Events

    baseline

  • +8 more secondary outcomes

Other Outcomes (2)

  • Discourse Global Coherence

    baseline

  • Discourse Local Coherence

    baseline

Study Arms (2)

Pakinson'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

Pakinson's disease with 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

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • 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
  • +9 more criteria

You may not qualify if:

  • History of unmanaged or untreated depression or major psychiatric illness
  • History of deep brain stimulation surgery (DBS)
  • Diagnosis of Dementia with Lewy Bodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Evanston, Illinois, 60201, United States

Location

Related Publications (10)

  • Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.

    PMID: 8487525BACKGROUND
  • Brookshire RH, Nicholas LE. Speech sample size and test-retest stability of connected speech measures for adults with aphasia. J Speech Hear Res. 1994 Apr;37(2):399-407. doi: 10.1044/jshr.3702.399.

    PMID: 8028321BACKGROUND
  • Capilouto G, Wright HH, Wagovich SA. CIU and main event analyses of the structured discourse of older and younger adults. J Commun Disord. 2005 Nov-Dec;38(6):431-44. doi: 10.1016/j.jcomdis.2005.03.005. Epub 2005 Apr 26.

    PMID: 16199238BACKGROUND
  • Roberts A, Post D. Information Content and Efficiency in the Spoken Discourse of Individuals With Parkinson's Disease. J Speech Lang Hear Res. 2018 Sep 19;61(9):2259-2274. doi: 10.1044/2018_JSLHR-L-17-0338.

    PMID: 30208482BACKGROUND
  • Thompson CK, Cho S, Hsu CJ, Wieneke C, Rademaker A, Weitner BB, Mesulam MM, Weintraub S. Dissociations Between Fluency And Agrammatism In Primary Progressive Aphasia. Aphasiology. 2012;26(1):20-43. doi: 10.1080/02687038.2011.584691.

    PMID: 22199417BACKGROUND
  • Thompson, C. K., Shapiro, L. P., Li, L., & Schendel, L. (1995). Analysis of verbs and verb-argument structure: A method for quantification of aphasic language production. Clinical Aphasiology, 23, 121-140.

    BACKGROUND
  • Harris Wright, H., Koutsoftas, A., Fergadiotis, G., & Capilouto, G. (2010). Coherence in Stories Told by Adults With Aphasia.

    BACKGROUND
  • Wright HH, Capilouto GJ. Considering a multi-level approach to understanding maintenance of global coherence in adults with aphasia. Aphasiology. 2012 Jan 1;26(5):656-672. doi: 10.1080/02687038.2012.676855. Epub 2012 May 10.

    PMID: 22962509BACKGROUND
  • Glosser G, Deser T. Patterns of discourse production among neurological patients with fluent language disorders. Brain Lang. 1991 Jan;40(1):67-88. doi: 10.1016/0093-934x(91)90117-j.

    PMID: 2009448BACKGROUND
  • Van Leer E, Turkstra L. The effect of elicitation task on discourse coherence and cohesion in adolescents with brain injury. J Commun Disord. 1999 Sep-Oct;32(5):327-48; quiz 348-9. doi: 10.1016/s0021-9924(99)00008-8.

    PMID: 10498013BACKGROUND

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2021

First Posted

June 18, 2023

Study Start

March 5, 2019

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations