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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04273672
Other study ID # H00011523
Secondary ID 5K23DC016656
Status Active, not recruiting
Phase
First received
Last updated
Start date January 13, 2020
Est. completion date February 2025

Study information

Verified date May 2024
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Investigators aim to identify speech and language markers that provide information on cognitive function and predict cognitive decline in Parkinson's disease. The Investigators will administer speech tasks and cognitive assessments to participants with Parkinson's disease and healthy controls. The Investigators will also explore the associations between genetic factors and speech and cognitive status in Parkinson's disease.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date February 2025
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Parkinson's Disease (or healthy control) - Disease duration = 2 years - Mild cognitive impairment or normal cognition Exclusion Criteria: - Diagnosis of dementia (MoCA <21) - Adults unable to consent - Age < 18 - Pregnant women - Prisoners - Non-English speakers - Any neurological disorder other than PD - Deep brain stimulator placement - Severe, unstable psychiatric disorder - Unintelligible speech due to effects of PD - Visual acuity or color vision impairment that would interfere with cognitive testing - Other voice, speech or swallowing disorders or history of surgery involving palate/nasopharynx/larynx/vocal cords

Study Design


Intervention

Diagnostic Test:
Cognitive Battery
Participants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities).
Behavioral:
Voice, Speech and Language Analysis
Participants will be asked to perform speaking and reading tasks, which will be recorded. Participants will be asked to complete a laptop-based test of language comprehension.
Questionnaires and Clinical Assessments
Participants with Parkinson's disease will complete an examination of their symptoms and questionnaires assessing disease symptoms, mood and activities of daily living. Healthy controls participants will be asked to complete questionnaires on mood.
Genetic:
DNA Analysis
Participants will have their blood drawn for DNA analysis.

Locations

Country Name City State
United States UMass Medical School/UMass Memorial Medical Center Worcester Massachusetts

Sponsors (5)

Lead Sponsor Collaborator
University of Massachusetts, Worcester Boston University, Massachusetts Institute of Technology, Lincoln Laboratories, National Institute on Deafness and Other Communication Disorders (NIDCD), VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of speech acoustic parameters that classify PD participants by cognitive status (mild cognitive impairment [MCI] vs. normal cognition) Gaussian regression modeling and other machine learning techniques will be used to develop a model including fundamental frequency, noise-to-harmonic ratio, cepstral peak prominence, formants, phoneme-dependent speaking rates and diadochokinesis rate and quality to predict categorization of PD participants by disease and cognitive status. 12-24 months
Primary Duration and location of pauses during speech in PD participants with and without mild cognitive impairment Participants will produce speech samples of spontaneous speech, which will be transcribed and coded for pause length and location, and these characteristics will be entered into a non-linear mixed model with the three-level predictor of group membership (control, PD-MCI, PD with normal cognition) as the parameter of interest. 12-24 months
Primary Syntax processing efficiency score (percentage correctly understood sentences/processing time) in controls, and in PD with and without MCI When presented with sentences of varying syntactical complexity in a self-paced task, participants response time and accuracy will be used to create multilevel models and test for effect of group (controls, PD, PD-MCI). 12-24 months
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