A Study to Analyze Symptoms Prevalent in Early PD (Dysphonia, Tremor)

• ClinicalTrials.gov Identifier: NCT04288804
• Recruitment Status: Recruiting
• First Posted: February 28, 2020
• Last Update Posted: July 21, 2020
• Sponsor: Goalspal LLC
• Information provided by (Responsible Party): Goalspal LLC

Study Description

Brief Summary:

This is a web-based study that involves monitoring hallmark symptoms of Parkinson's Disease (PD), specifically dysphonia and tremor, using smartphone sensor data. The entire length of the study will only take 5 minutes, so volunteers will not have to repeatedly contribute data. The study is made up of 5 short, 10-second long activities, which include sustaining the short a vowel sound to monitor changes in vocal fundamental frequency and holding a smartphone in different positions on either side of the body to measure changes in amplitude. To be a part of this study, volunteers must have an iPhone that is running on the software iOS 13 or higher, because they will be asked to download a smartphone application from an online App Store.

Condition or disease	Intervention/treatment
Parkinson Disease	Device: Smartphone microphone sensor; Device: Smartphone accelerometer sensor

Detailed Description:

Participants will be asked to complete a series of activities, as outlined below.

1. They will be asked to turn on "Do Not Disturb" and set their smartphone's volume to the maximum. This is to ensure that they can hear narrated instructions guiding them through the activities to come, and that data collection is uninterrupted.
2. Volunteers will sustain the short a vowel sound for 10 seconds. This is to analyze PD-related dysphonia.
3. Volunteers will place their smartphone in their left hand and rest it in their lap for 10 seconds. This is to analyze PD-related rest tremor on the left side of the body. (Duration: 10 seconds)
4. Volunteers will place their smartphone in their right hand and rest it in their lap for 10 seconds. This is to analyze PD-related rest tremor on the right side of the body. (Duration: 10 seconds)
5. Volunteers will hold their smartphone face-down at shoulder-level, in their left hand. This is to analyze PD-related postural tremor on the left side of the body. (Duration: 10 seconds)
6. Volunteers will hold their smartphone face-down at shoulder-level, in their right hand. This is to analyze PD-related postural tremor on the right side of the body. (Duration: 10 seconds)

Finally, participants will be asked to indicate their gender, age group, and status (whether or not they have PD), for data-labeling purposes. Please note that all data is collected anonymously and thus cannot be tracked down to a specific participant. Nevertheless, it will be encrypted and stored in a secure database, with each participant corresponding to a GUID (Global Unique Identifier), although participants will not be asked for their name. As this is not a medical study, there are no expected medical side effects, however, certain activities and questions may seem frustrating and boring.

Participants will mainly benefit from the study indirectly, as it will increase understanding of symptoms prevalent in early PD, and may contribute to the development of diagnostic tools.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 1000 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 1 Day
• Official Title: A Study to Analyze Features of Dysphonia and Tremor in PD Patients to Aid in the Development of an Accurate Diagnostic Tool for Early-Detection of PD
• Actual Study Start Date: February 26, 2020
• Estimated Primary Completion Date: December 26, 2020
• Estimated Study Completion Date: December 26, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Control (healthy, non-PD participants); An audio file made up of a voice recording of the sustained short a vowel sound, along with accelerometer data while maintaining various positions, will be collected.	Device: Smartphone microphone sensor; The volunteer will record themselves sustaining the short a vowel sound for 10 seconds.; Device: Smartphone accelerometer sensor; The volunteer's smartphone's accelerometer will record accelerometer data (positions on the x, y, and z axes) while the volunteer maintains 4 positions, each for 10 seconds.
PD; An audio file made up of a voice recording of the sustained short a vowel sound, along with accelerometer data while maintaining various positions, will be collected.	Device: Smartphone microphone sensor; The volunteer will record themselves sustaining the short a vowel sound for 10 seconds.; Device: Smartphone accelerometer sensor; The volunteer's smartphone's accelerometer will record accelerometer data (positions on the x, y, and z axes) while the volunteer maintains 4 positions, each for 10 seconds.

Outcome Measures

Primary Outcome Measures :

1. PD-related Tremor [ Time Frame: 40 seconds ]
   24 features, composed of mean absolute deviation and mean standard deviation for each axis (x, y, z), for 4 likely occurrences of tremor, will be observed by looking at the accelerometer data file of each participant.
2. PD-related Dysphonia [ Time Frame: 10 seconds ]
   Features, composed of vocal fundamental frequency, and similar measures to jitter and shimmer, will be observed by looking at the mel spectrogram for the audio file of each participant.

Biospecimen Retention:   Samples Without DNA

Accelerometer data, voice recording, question responses (age-group, gender, PD/non-PD)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Subjects must be healthy controls, or clinically diagnosed with PD in order to participate. They also may not have another illness that causes tremor and/or dysphonia - subjects who have PD must also have PD-related dysphonia and PD-related tremor.

Criteria

Inclusion Criteria:

• Clinical diagnosis of Parkinson's Disease (PD)
• Healthy

Exclusion Criteria:

• Subject does not have clinical diagnosis of PD, however, has another neurological disorder/disease that manifests with symptoms of tremor or dysphonia
• Subject diagnosed with PD does not have dysphonia and tremor

Contacts and Locations

Contacts

Contact: Nitya Ayyagari; (925) 699-0817 ext +1; admin@goalspal.com

Locations

United States, California

Goalspal LLC; Recruiting

Pleasanton, California, United States, 94566

Contact: Nitya Ayyagari 925-699-0817 ext +1 admin@goalspal.com

Sponsors and Collaborators

Goalspal LLC

More Information

Additional Information:

A visual protocol of what the study entails, complete with pictures of each screen wherein a volunteer must complete a certain activity, and how to download the mobile study. 

• Responsible Party: Goalspal LLC
• ClinicalTrials.gov Identifier: NCT04288804
• Other Study ID Numbers: NIA0117210
• First Posted: February 28, 2020
• Last Update Posted: July 21, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: De-identified participant data may be made available to other researchers in a compiled dataset. 24 accelerometer features from each participant will be included in their entry, tagged by a GUID. Along with this, an audio file of them sustaining the short a vowel sound for 10 seconds will be a part of their entry. Finally, their status (control/PD), gender, and age-group will be included, so that statistical analyses can be made.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Goalspal LLC:

Parkinson's Disease; Dysphonia; Tremor; Neurological Disorder; Web-based; Neurological Disease

Additional relevant MeSH terms:

Dysphonia; Hoarseness; Parkinson Disease; Tremor; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Signs and Symptoms, Respiratory