COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-27

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05421832

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.

Ages Eligible for Study:30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female age 30 years or older at Screening Visit. 2. Diagnosis of PD as defined by MDS PD diagnostic criteria \[1\] 3. 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) 4. Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments. 5. Able to provide informed consent. 1. Confirmation that participant is eligible based on clinician determined predictive criteria of known risk of PD including 1. Rapid eye movement sleep behavior disorder (RBD), possible, probable or definite, OR 2. Hyposmia defined as less than 10th percentile on University of Pennsylvania Smell Identification Test (UPSIT), age and gender adjusted, OR 3. Known genetic variants associated with PD risk, AND Confirmed eligible DAT scan. 2. Male or female age 30 or older at Screening Visit. 3. Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments 4. Able to provide informed consent. 1. Male or female age 30 years or older at Screening visit. 2. Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments 3. Able to provide informed consent.	1. Late-stage PD diagnosis (i.e., Hoehn \& Yahr Stage 5) at Screening Visit 2. 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). 3. Current or active clinically significant neurological disorder other than PD (in the opinion of the Investigator). 4. Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation. 5. History of drug and/or alcohol abuse within the past year prior to Screening Visit. 6. Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments. 7. Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation. 1. Clinical diagnosis of PD, other parkinsonism, or dementia. 2. Any current or active clinically significant neurological disorder (in the opinion of the Investigator). 3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator). 4. Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation. 5. History of drug and/or alcohol abuse within the past year prior to Screening Visit. 6. Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments. 7. Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation. 1. First degree relative with PD (i.e., biologic parent, sibling, child). 2. Any current or active clinically significant neurological disorder (in the opinion of the Investigator). 3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator). 4. Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation. 5. History of drug and/or alcohol abuse within the past year prior to Screening Visit. 6. Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments. 7. Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation

Inclusion Criteria

Exclusion Criteria

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

1. Late-stage PD diagnosis (i.e., Hoehn \& Yahr Stage 5) at Screening Visit
2. 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).
3. Current or active clinically significant neurological disorder other than PD (in the opinion of the Investigator).
4. Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
5. History of drug and/or alcohol abuse within the past year prior to Screening Visit.
6. Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
7. Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation.
1. Clinical diagnosis of PD, other parkinsonism, or dementia.
2. Any current or active clinically significant neurological disorder (in the opinion of the Investigator).
3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
4. Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
5. History of drug and/or alcohol abuse within the past year prior to Screening Visit.
6. Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
7. Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation.
1. First degree relative with PD (i.e., biologic parent, sibling, child).
2. Any current or active clinically significant neurological disorder (in the opinion of the Investigator).
3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
4. Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
5. History of drug and/or alcohol abuse within the past year prior to Screening Visit.
6. Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
7. Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation

Contacts and Locations

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Northwestern University

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 Registration Dates

Study Start Date2022-09-27

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-09-27

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Parkinson Disease