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

Parkinson Disease Clinical Trial

— Voice-PD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421832
• Other study ID #: STU00216902
• Status: Recruiting
• Start date: September 27, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: Max Galarce
• Phone: 312-503-4270
• Email: max.galarce[@]northwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

PD:

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.

Prodromal PD:

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.

Age & Sex Matched Healthy Control:

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.

Exclusion Criteria:

PD:

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.

Prodromal PD:

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.

Age & Sex Matched Healthy Control:

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Digital Speech Application
A custom smartphone-based speech assessment tool to extract multiple hypothesis-driven acoustic features from patient speech in a real-life environment.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Koneksa Health, Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance of digital speech assessment data recorded via smartphone assessments	o % Interpretable minutes of data per patient	8 weeks
Primary	Quality of digital speech assessment data recorded via smartphone assessments	o % Interpretable vs. expected number of minutes of data per patient by complete days on study	8 weeks
Primary	Usability of digital speech assessments	o SUS Usability scores by score, grade and adjective rating	8 weeks
Primary	Content validity of digital speech assessments	o Percent of patients that score Excellent or Good for usability ratings	8 weeks
Secondary	Characterization and reliability of digital speech assessment features	o Candidate feature characterization: response distributions, and outlier analysis. Stratification of sustained phonation measures by MDS-UPDRS relevant speech items	8 weeks
Secondary	Reliability of digital speech assessment features	internal consistency and test-retest reliability	8 weeks
Secondary	Predictive performance of machine learning (ML) regression model	o Construct validity: convergent validity of each model output versus relevant MDS-UPDRS speech items and Parts I-IV total score, respectively; and versus Hoehn & Yahr Stage	8 weeks
Secondary	Predictive performance of ML classification model	o Known group validity by cohort (including by H&Y Stage/ MDS-UPDRS Parts I-IV total score)	8 weeks