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

Parkinson Disease Clinical Trial

— mPower  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02696603
• Other study ID #: 201410711
• Secondary ID: 20141369
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2016
• Last updated: October 20, 2017
• Start date: March 2015
• Est. completion date: February 2018

Study information

• Verified date: October 2017
• Source: Sage Bionetworks
• Contact: Lara Mangravite, PhD
• Phone: 2066672102
• Email: lara.mangravite[@]sagebase.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Ganglia Diseases
• Brain Diseases
• Central Nervous System Diseases
• Disease
• Movement Disorders
• Nervous System Diseases
• Neurodegenerative Diseases
• Parkinson Disease
• Parkinsonian Disorders

Intervention

Behavioral:
• Participant self-assessment surveys
At enrollment, participants are asked to complete a baseline health history and a participant-reported symptom inventory. Thereafter, participants are asked to respond to commonly used questions that assess Parkinson Disease symptoms and quality of life at regular intervals.
• Phonation
Participants are asked to record themselves saying "Aaah" for 10 seconds using the iPhone microphone. This activity is designed to assess vocal features, including vocal tremor. The investigators extract features from the digital audio signals of these 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.
• Gait and balance
Participants are asked to walk back and forth for 30 seconds and then stand still for 30 seconds. Gait and balance are measured by gyroscope and accelerometer sensors. The investigators examine step-dependent and sequence-dependent features from these sensors. The investigators apply feature selection and classifier algorithms to analyze these data.
• Memory
Participants are asked to complete a visuospatial short-term memory game related to the Corsi block tapping test [Corsi, P.M. (1972)] as adapted by Kate Possin, PhD of the University of California San Francisco Memory and Aging Center (personal communication, 2015). In this activity, participants are presented with a grid of objects that change color in a set pattern. Participants are then asked to tap the objects in that same pattern. The investigators assess the sequence length completed.
• Dexterity
Participants are asked to tap on the phone screen with alternating fingers. This test can be done with either or both hands. The investigators record the rhythm, speed, and location of these taps using the touch sensors of the iPhone screen. The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision.
• Participant open-response writing
Qualitative participant feedback is used to assess participant engagement with, understanding of, and acceptance of app-based research.

Other:
• Parkinson mPower mobile application
Participants complete all described behavioral interventions via a dedicated iPhone app, Parkinson mPower.

Locations

Country	Name	City	State
United States	Sage Bionetworks	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Sage Bionetworks	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Chaibub Neto E, Bot BM, Perumal T, Omberg L, Guinney J, Kellen M, Klein A, Friend SH, Trister AD. PERSONALIZED HYPOTHESIS TESTS FOR DETECTING MEDICATION RESPONSE IN PARKINSON DISEASE PATIENTS USING iPHONE SENSOR DATA. Pac Symp Biocomput. 2016;21:273-84. — View Citation

Corsi, P.M. (1972). Human memory and the medial temporal region of the brain (Ph.D.). McGill University.

Kessels RP, van Zandvoort MJ, Postma A, Kappelle LJ, de Haan EH. The Corsi Block-Tapping Task: standardization and normative data. Appl Neuropsychol. 2000;7(4):252-8. — View Citation

Klucken J, Barth J, Kugler P, Schlachetzki J, Henze T, Marxreiter F, Kohl Z, Steidl R, Hornegger J, Eskofier B, Winkler J. Unbiased and mobile gait analysis detects motor impairment in Parkinson's disease. PLoS One. 2013;8(2):e56956. doi: 10.1371/journal.pone.0056956. Epub 2013 Feb 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of participant self-assessment surveys	Results of participant self-assessment surveys will be analyzed using descriptive statistics. These results may also be compared with other intervention results.	Through study completion, an average of 1 year
Primary	Digital audio signals of sustained phonation from phonation intervention	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.	Through study completion, an average of 1 year
Primary	Gyroscope and accelerometer sensor measurements from gait and balance intervention	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.	Through study completion, an average of 1 year
Primary	Sequence length from memory intervention	The investigators assess the sequence length completed in the Memory intervention. These results may also be compared with other intervention results.	Through study completion, an average of 1 year
Primary	iPhone screen touch sensor data on rhythm, speed, and location of taps from dexterity intervention	The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision. These results may also be compared with other intervention results.	Through study completion, an average of 1 year
Primary	App usage data for assessment of participant engagement	App usage data is used to gauge participant engagement throughout the study period. These results may also be compared with other intervention results.	Through study completion, an average of 1 year
Primary	Qualitative analysis of participant open-response and app usage data to assess participant acceptance of app-based research	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.	Through study completion, an average of 1 year

External Links

•   mPower study website