Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Dyskinesia, Tremor, Symptom Management, Technology, Wearable Sensors, Continuous Monitoring, Mobility
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.
Interventions
DEVICEKinesia 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.
Sponsors
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
Great Lakes NeuroTechnologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of assigned days with confirmed use | 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Diary measured On time with dyskinesia | 5 months |
| Off time as measured by Kinesia 360 | 5 months |
| On time with dyskinesia as measured by Kinesia 360 | 5 months |
| PDQ-39 responses | 5 months |
| Patient Assessment for Chronic Conditions (PACIC) responses | 5 months |
| Diary measured Off time | 5 months |
| Number of clinic visits | 5 months |
| Number of patient/investigator communications | 5 months |
| Unified Parkinson's disease rating scale (UPDRS) | 5 months |
| Duration of time with patient | 5 months |
| Number and type of medication changes | 5 months |
| Patient Activation Measure (PAM)-13 responses | 5 months |
Countries
United States
Outcome results
None listed