Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)

Not Applicable

• Conditions: Central Nervous System Diseases; Basal Ganglia Diseases; Parkinsonian Disorders; Parkinson Disease; Neurodegenerative Diseases; Movement Disorders; Brain Diseases
• Interventions: Behavioral: Participant self-assessment surveys; Behavioral: Phonation; Behavioral: Gait and balance; Behavioral: Memory; Behavioral: Dexterity; Behavioral: Participant open-response writing; Other: Parkinson mPower mobile application

• Registration Number: NCT02696603
• Lead Sponsor: Sage Bionetworks

Brief Summary

The purpose of this study is to understand variation in the symptoms of Parkinson disease. This study uses an iPhone app to record these symptoms through questionnaires and sensors.

Detailed Description

Living with Parkinson disease means coping with symptoms that change every day. Yet these changes are not tracked frequently enough. Most people with Parkinson disease see a clinician only once or twice a year. This study measures changes in Parkinson disease symptoms in real time using an app. The app remotely monitors Parkinson disease symptoms using surveys and the sensors on mobile devices. This study may contribute to increasing our understanding of the variability in Parkinson disease symptoms. This knowledge could be used to improve quality of life for people living with Parkinson disease.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-24
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

1. Age 18 years
2. Have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
3. Be able to read and understand an official language of the country of participation
4. Be able to provide informed consent (i.e., pass assessment quiz)
5. Be willing to follow study procedures

Exclusion Criteria

1. Age 17 years or younger
2. Not a resident of the of a country where the app is approved for use
3. Not have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
4. Not be able to read and understand an official language of the country of participation
5. Not be able to give informed consent
6. Not be willing to follow study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with Parkinson disease	Participant self-assessment surveys	People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants with Parkinson disease	Participant open-response writing	People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants without Parkinson disease	Participant self-assessment surveys	People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants without Parkinson disease	Gait and balance	People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants with Parkinson disease	Phonation	People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants without Parkinson disease	Phonation	People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants with Parkinson disease	Dexterity	People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants with Parkinson disease	Parkinson mPower mobile application	People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants without Parkinson disease	Dexterity	People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants with Parkinson disease	Gait and balance	People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants with Parkinson disease	Memory	People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants without Parkinson disease	Memory	People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants without Parkinson disease	Parkinson mPower mobile application	People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.
Participants without Parkinson disease	Participant open-response writing	People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

Primary Outcome Measures

Name	Time	Method
Results of participant self-assessment surveys	Through study completion, an average of 1 year	Results of participant self-assessment surveys will be analyzed using descriptive statistics. These results may also be compared with other intervention results.
App usage data for assessment of participant engagement	Through study completion, an average of 1 year	App usage data is used to gauge participant engagement throughout the study period. These results may also be compared with other intervention results.
Sequence length from memory intervention	Through study completion, an average of 1 year	The investigators assess the sequence length completed in the Memory intervention. These results may also be compared with other intervention results.
iPhone screen touch sensor data on rhythm, speed, and location of taps from dexterity intervention	Through study completion, an average of 1 year	The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision. These results may also be compared with other intervention results.
Qualitative analysis of participant open-response and app usage data to assess participant acceptance of app-based research	Through study completion, an average of 1 year	App usage data and qualitative participant feedback are used to assess participant understanding and acceptance of app-based research. These results may also be compared with other intervention results.
Digital audio signals of sustained phonation from phonation intervention	Through study completion, an average of 1 year	The investigators extract features from the digital audio signals of sustained phonations. The investigators apply feature selection and classifier algorithms and analyze these phonations using methods similar to those employed in the Parkinson Voice Initiative (http://www.parkinsonsvoice.org/science.php). These results may also be compared with other intervention results.
Gyroscope and accelerometer sensor measurements from gait and balance intervention	Through study completion, an average of 1 year	The investigators examine step-dependent and sequence-dependent features from gyroscope and accelerometer sensors. The investigators apply feature selection and classifier algorithms to analyze these data. These results may also be compared with other intervention results.

Trial Locations

Locations (1)

Sage Bionetworks; 🇺🇸 Seattle, Washington, United States