A Novel Measurement Concept to Objectively Quantify Severity of Vocal and Speech Related Symptoms Associated With Parkinson's Disease (Voice-PD)

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    120
  • sponsor
    Northwestern University
Updated on 24 October 2022
Accepts healthy volunteers

Summary

The aim of this research program is to develop and validate a smartphone app-based digital measurement concept that:

  • Objectively quantifies the severity of Parkinson's Disease (PD) related vocal and speech symptoms;
  • Accurately and sensitively identifies vocal and speech abnormalities associated with the prodromal stage of PD.

Description

Although multiple approaches to this problem have been proposed in addition to commercially available speech analytics platforms, there is currently no established measure which incorporates the disparate aspects of affected speech to fully characterize Parkinson's symptom progression, particularly in the prodromal phase.

The measurement concept being evaluated in the present study utilizes a custom smartphone-based speech assessment tool to extract multiple hypothesis-driven acoustic features from patient speech in a real-life environment. The resultant features will be used to train a pair of supervised machine learning models to predict clinical PD symptom severity scores, and to distinguish prodromal PD patients from both healthy matched controls and PD patients in more advanced phases of disease progression.

Details
Condition Parkinson Disease
Treatment Digital Speech Application
Clinical Study IdentifierNCT05421832
SponsorNorthwestern University
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

PD
Male or female age 30 years or older at Screening Visit
Diagnosis of PD as defined by MDS PD diagnostic criteria [1]
PD severity at Screening Visit of either
PD Hoehn and Yahr Stage 1-2, inclusive (PD Cohort I)
PD Hoehn and Yahr Stages 3-4, inclusive (PD Cohort II)
Able and willing to complete all aspects of the study, including at home smartphone
app and Zoom telehealth assessments
Able to provide informed consent
Prodromal PD
Confirmation that participant is eligible based on clinician determined predictive criteria of known risk of PD including
Rapid eye movement sleep behavior disorder (RBD), possible, probable or definite, OR
Hyposmia defined as less than 10th percentile on University of Pennsylvania Smell Identification Test (UPSIT), age and gender adjusted, OR
Known genetic variants associated with PD risk, AND Confirmed eligible DAT scan
Male or female age 30 or older at Screening Visit
Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments
Able to provide informed consent
Age & Sex Matched Healthy Control
Male or female age 30 years or older at Screening visit
Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments
Able to provide informed consent

Exclusion Criteria

PD
Late-stage PD diagnosis (i.e., Hoehn & Yahr Stage 5) at Screening Visit
Symptomatic or atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy)
Current or active clinically significant neurological disorder other than PD (in the opinion of the Investigator)
Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation
History of drug and/or alcohol abuse within the past year prior to Screening Visit
Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments
Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation
Prodromal PD
Clinical diagnosis of PD, other parkinsonism, or dementia
Any current or active clinically significant neurological disorder (in the opinion of the Investigator)
Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator)
Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation
History of drug and/or alcohol abuse within the past year prior to Screening Visit
Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments
Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation
Age & Sex Matched Healthy Control
First degree relative with PD (i.e., biologic parent, sibling, child)
Any current or active clinically significant neurological disorder (in the opinion of the Investigator)
Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator)
Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation
History of drug and/or alcohol abuse within the past year prior to Screening Visit
Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments
Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation
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