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Trial record 6 of 6 for:    sonde

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

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ClinicalTrials.gov Identifier: NCT04273672
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : March 11, 2021
Sponsor:
Collaborators:
Sonde Health
Massachusetts Institute of Technology/Lincoln Labs
Boston University
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Kara Smith, University of Massachusetts, Worcester

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

Condition or disease Intervention/treatment
Parkinson Disease Cognitive Impairment, Mild Speech Diagnostic Test: Cognitive Battery Behavioral: Voice, Speech and Language Analysis Behavioral: Questionnaires and Clinical Assessments Genetic: DNA Analysis

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Speech, Linguistic and Acoustic Markers in Parkinson's Disease
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. We will develop a regression model using speech acoustic parameters to classify PD participants by cognitive status (mild cognitive impairment [MCI] vs. normal cognition) [ Time Frame: 12-24 months ]
    We will use a Gaussian regression model and other machine learning techniques 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.

  2. We will measure the difference in number and duration of within-utterance pauses, and pauses before verbs 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.

  3. We will measure 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).


Biospecimen Retention:   Samples With DNA
Blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273672


Contacts
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Contact: Kara Smith, MD 508-856-2527 kara.smith@umassmemorial.org
Contact: Meaghan Demers-Peel, BS 774-445-6568 meaghan.demers-peel@umassmed.edu

Locations
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United States, Massachusetts
UMass Medical School/UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Sonde Health
Massachusetts Institute of Technology/Lincoln Labs
Boston University
VA Puget Sound Health Care System
Investigators
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Principal Investigator: Kara Smith, MD UMass Medical School
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Responsible Party: Kara Smith, Assistant Professor of Neurology, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT04273672    
Other Study ID Numbers: H00011523
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders