Speech, Linguistic and Acoustic Markers in Parkinson's Disease (SLAM-PD)

September 26, 2023 updated by: Kara Smith, University of Massachusetts, Worcester
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Medical School/UMass Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults with Parkinson's Disease and mild cognitive impairment or normal cognition as well as controls

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson's Disease
Subjects with Parkinson's Disease
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.
Behavioral: 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.
Control
Subjects without Parkinson's Disease
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of speech acoustic parameters that classify PD participants by cognitive status (mild cognitive impairment [MCI] vs. normal cognition)
Time Frame: 12-24 months
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
Duration and location of pauses during speech in PD participants with and without mild cognitive impairment
Time Frame: 12-24 months
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
Syntax processing efficiency score (percentage correctly understood sentences/processing time) in controls, and in PD with and without MCI
Time Frame: 12-24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

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

Investigators

  • Principal Investigator: Kara Smith, MD, UMass Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Actual)

September 1, 2023

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H00011523
  • 5K23DC016656 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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