Status:
COMPLETED
A Novel Measurement Concept to Objectively Quantify Severity of Vocal and Speech Related Symptoms Associated With Parkinson's Disease
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Koneksa Health
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Brief 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 an...
Detailed 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 dispa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT05421832
Start Date
September 27 2022
End Date
June 30 2025
Last Update
July 24 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611