Objective Quality of Life Detection Validation

DiSCERN Phase I - Objective Quality of Life Detection Validation

The purpose of this research study is to:

• Collect data to use in the development of a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) such as deep brain stimulation (DBS) and drug pumps.
• Determine the level to which specific activities reflect with quality of life in individuals with PD.
• Obtain feedback from individuals with Parkinson's disease and clinicians on the usability of the system.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Kinesia 360 and Smartphone sensors

Detailed Description

The investigators aim to develop a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) and identify when AT recipients are in need of a therapy adjustment. This system will integrate ambulatory PD monitoring with context aware activity detection as the daily activities a patient performs are often the best predictors of quality of life (QoL). In this study the Kinesia 360 system will collect motion data to measure tremor, bradykinesia (slow movement), and dyskinesia (involuntary movements) from individuals with PD to track their symptoms throughout the day. A smartphone will collect information on subject location and activity using the GPS, accelerometers, and microphone within the phone to find correlations between activity and patient wellness. This data will be used to improve detection over time and predict whether patients are candidates for advanced therapies.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44131
      • Great Lakes NeuroTechnologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population is people with Parkinson's Disease in the Northeast Ohio region who have expressed interest in participating in clinical trials

Description

Inclusion Criteria:

1. Able to provide informed consent
2. Diagnosed with PD
3. Hoehn and Yahr scale I-III
4. Able to travel to Great Lakes NeuroTechnologies
5. Ambulatory and capable of using the Kinesia 360 system
6. Able to understand and follow instructions regarding using the device

Exclusion Criteria:

Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's Disease; Parkinson's Disease patients	Device: Kinesia 360 and Smartphone sensors; Data will be recorded from the Kinesia 360 system and smartphone sensors using the AWARE Framework.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinesia Symptom Scores during Daily Wear	Kinesia 360 scoring of Parkinson's Disease motor symptoms (tremor, slowness, dyskinesia, gait): The Kinesia 360 system translates recorded motion into 0-4 scores that correlate to rating scales used by clinicians (lower scores are signifiers of better outcomes and higher scores signify worse outcomes). A separate 0-4 score is generated for tremor, slowness, and dyskinesia, and gait is tracked for step count and percent of day walking.	Continuous during wear over four days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User environment audio activity	Using the AWARE Framework, the microphone in the smartphone will be used to measure ambient noise and detect conversation during wear. The output will be detection of conversation and ambient noise level for each recorded timepoint. The time involved in conversation and around active ambient noise will be compared to the symptom scores to measure user involvement in active environments as an impact on Parkinson's disease symptoms.	Continuous during wear over four days
Patient physical activity	Using the AWARE Framework, accelerometers in the smartphone will be used to determine the activity of the user. The accelerometers will detect if the phone is being carried (using orientation of gravity) and predict most likely physical activity (using pre-existing activity recognition algorithms). The output will be predicted user activity for each timepoint recorded which will be correlated to Kinesia symptom scores.	Continuous during wear over four days
Patient locations and travel	Using the AWARE Framework, Global Positioning System (GPS) tracking in the smartphone will be used to determine the locations and activity of the user. The GPS sensor will be used to track changes in location and determine when an user is at home (primary location), in a secondary location, or in active motion (car, bike, or walking). The outcome will be time spent in each location, percent of day at each location, and time and speed travelling between locations. These outcomes will be correlated to the Kinesia symptom scores and detected physical activity.	Continuous during wear over four days

Collaborators and Investigators

• Sponsor: Great Lakes NeuroTechnologies Inc.
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Dustin Heldman, PhD, Director of research

Publications and helpful links

General Publications

• Heldman DA, Giuffrida JP, Cubo E. Wearable Sensors for Advanced Therapy Referral in Parkinson's Disease. J Parkinsons Dis. 2016 Jul 2;6(3):631-8. doi: 10.3233/JPD-160830.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: DiSCERN1; 1R44MD013767-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No