A smartphone app to measure speech symptoms in Parkinson's Disease

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

This study is testing a smartphone app that measures speech problems in people with Parkinson's Disease to see how well it can track their symptoms in everyday life.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05421832 on ClinicalTrials.gov

What this trial studies

This research program aims to develop and validate a smartphone app that objectively quantifies the severity of vocal and speech-related symptoms in individuals with Parkinson's Disease (PD). The app will utilize a custom speech assessment tool to extract various acoustic features from patient speech in real-life settings. These features will be analyzed using machine learning models to predict clinical PD symptom severity and differentiate between prodromal PD patients and those in more advanced stages of the disease. The study seeks to provide a comprehensive measurement approach that has not been established previously.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 30 and older with a diagnosis of Parkinson's Disease or those exhibiting prodromal symptoms such as REM sleep behavior disorder or hyposmia.

Not a fit: Patients with advanced Parkinson's Disease who are unable to participate in smartphone assessments or those without the specified prodromal symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this app could provide a more accurate and sensitive method for monitoring speech symptoms in Parkinson's Disease, potentially leading to earlier diagnosis and better management of the condition.

How similar studies have performed: While there have been various approaches to measuring speech symptoms in PD, this specific smartphone-based method is novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Chicago, Illinois

• Northwestern University — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Max Galarce

Conditions Parkinson Disease