Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2016-01-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Kinesia 360 Users
Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors.
Kinesia 360
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.
Interventions
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Kinesia 360
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.
Eligibility Criteria
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Inclusion Criteria
* History of motor fluctuations (2 hrs/day of Off time and/or 1 hr/day of troublesome dyskinesia)
* Fluent in English
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of South Carolina School of Medicine, Greenville
UNKNOWN
University of Rochester
OTHER
Johns Hopkins University
OTHER
Prisma Health-Upstate
OTHER
National Institute on Aging (NIA)
NIH
The Cleveland Clinic
OTHER
Great Lakes NeuroTechnologies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dustin Heldman, PhD
Role: PRINCIPAL_INVESTIGATOR
Great Lakes NeuroTechnologies Inc.
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
University of Rochester
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Greenville Health System
Greenville, South Carolina, United States
Countries
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Other Identifiers
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