Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
140 participants
OBSERVATIONAL
2019-03-05
2023-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Speech, Linguistic and Acoustic Markers in Parkinson's Disease
NCT04273672
A Novel Measurement Concept to Objectively Quantify Severity of Vocal and Speech Related Symptoms Associated With Parkinson's Disease
NCT05421832
Neuroplasticity in Parkinson's Disease
NCT05286736
Social Cognition Dysfunctions in Parkinson's Disease
NCT05230095
SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
NCT05765110
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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
* History of deep brain stimulation surgery (DBS)
* Diagnosis of Dementia with Lewy Bodies
50 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Northwestern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Angela Roberts
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwestern University
Evanston, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Harris Wright, H., Koutsoftas, A., Fergadiotis, G., & Capilouto, G. (2010). Coherence in Stories Told by Adults With Aphasia.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
SALT Subordination index
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STU00209602
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.