Back to resultsKinesia 360 Parkinson's Monitoring Study
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kinesia 360
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Parkinson's Disease, Dyskinesia, Tremor, Symptom Management, Technology, Wearable Sensors, Continuous Monitoring, Mobility
Eligibility Criteria
Inclusion Criteria:
- Idiopathic Parkinson's Disease,
- History of motor fluctuations (2 hrs/day of Off time and/or 1 hr/day of troublesome dyskinesia)
- Fluent in English
Exclusion Criteria:
- Inability to carry out study activities
- Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
- Subjects who have dementia, exhibited by Montreal Cognitive Assessment (MoCa) score of 22 or less.
- Subjects who have had Deep Brain Stimulation (DBS) surgery less than 6 months prior to study enrollment, or who are deemed by the study investigator to be highly likely to undergo DBS surgery during the 6 month study period.
Sites / Locations
- Johns Hopkins University
- University of Rochester
- Cleveland Clinic
- Greenville Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Kinesia 360 Users
Arm Description
Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors.
Outcomes
Primary Outcome Measures
% of assigned days with confirmed use
Secondary Outcome Measures
Diary measured Off time
Diary measured On time with dyskinesia
Off time as measured by Kinesia 360
On time with dyskinesia as measured by Kinesia 360
PDQ-39 responses
Patient Assessment for Chronic Conditions (PACIC) responses
Patient Activation Measure (PAM)-13 responses
Number of clinic visits
Number of patient/investigator communications
Unified Parkinson's disease rating scale (UPDRS)
Duration of time with patient
Number and type of medication changes
Full Information
NCT ID
NCT02657655
First Posted
January 14, 2016
Last Updated
February 15, 2018
Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
University of South Carolina School of Medicine, Greenville, University of Rochester, Johns Hopkins University, Prisma Health-Upstate, National Institute on Aging (NIA), The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02657655
Brief Title
Kinesia 360 Parkinson's Monitoring Study
Official Title
Kinesia 360 Multi-Center Parkinson's Monitoring Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
University of South Carolina School of Medicine, Greenville, University of Rochester, Johns Hopkins University, Prisma Health-Upstate, National Institute on Aging (NIA), The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Kinesia 360 is an ambulatory symptom monitoring device for Parkinson's Disease (PD). The aim of this study is to investigate the impact, validation, and usability of the Kinesia 360 system.
Detailed Description
This is a five-month study of 45 subjects (approximately 15 subjects per site), consisting of adult volunteers that have been clinically diagnosed with Parkinson's disease. Subjects will have a confirmed history of motor fluctuation with a variety of Parkinson's disease symptom severities. All subjects will user the Kinesia 360 system and complete motor diaries several times per month during the study period. Symptom reports will be provided to the treating clinical team. Motor function, quality of life, engagement, and satisfaction with care will be tracked throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Dyskinesia, Tremor, Symptom Management, Technology, Wearable Sensors, Continuous Monitoring, Mobility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kinesia 360 Users
Arm Type
Experimental
Arm Description
Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors.
Intervention Type
Device
Intervention Name(s)
Kinesia 360
Intervention Description
Kinesia 360 includes a mobile app and wireless motion sensors worn on the patient's wrist and ankle to quantify tremor, dyskinesias, and mobility throughout the day as he or she goes about normal activities. The app includes electronic diaries enable patients to rate their symptoms and log when medications are taken. Data is transferred to a cloud server where motor symptom reports are generated for clinician review.
Primary Outcome Measure Information:
Title
% of assigned days with confirmed use
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Diary measured Off time
Time Frame
5 months
Title
Diary measured On time with dyskinesia
Time Frame
5 months
Title
Off time as measured by Kinesia 360
Time Frame
5 months
Title
On time with dyskinesia as measured by Kinesia 360
Time Frame
5 months
Title
PDQ-39 responses
Time Frame
5 months
Title
Patient Assessment for Chronic Conditions (PACIC) responses
Time Frame
5 months
Title
Patient Activation Measure (PAM)-13 responses
Time Frame
5 months
Title
Number of clinic visits
Time Frame
5 months
Title
Number of patient/investigator communications
Time Frame
5 months
Title
Unified Parkinson's disease rating scale (UPDRS)
Time Frame
5 months
Title
Duration of time with patient
Time Frame
5 months
Title
Number and type of medication changes
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic Parkinson's Disease,
History of motor fluctuations (2 hrs/day of Off time and/or 1 hr/day of troublesome dyskinesia)
Fluent in English
Exclusion Criteria:
Inability to carry out study activities
Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
Subjects who have dementia, exhibited by Montreal Cognitive Assessment (MoCa) score of 22 or less.
Subjects who have had Deep Brain Stimulation (DBS) surgery less than 6 months prior to study enrollment, or who are deemed by the study investigator to be highly likely to undergo DBS surgery during the 6 month study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dustin Heldman, PhD
Organizational Affiliation
Great Lakes NeuroTechnologies Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Kinesia 360 Parkinson's Monitoring Study
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