A Novel Measurement Concept to Objectively Quantify Severity of Vocal and Speech Related Symptoms Associated With Parkinson's Disease
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.
• 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.