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Kinesia 360 Parkinson's Monitoring Study

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ClinicalTrials.gov Identifier: NCT02657655
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : February 19, 2018
Sponsor:
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
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Kinesia 360 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Kinesia 360 Multi-Center Parkinson's Monitoring Study
Actual Study Start Date : January 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kinesia 360 Users
Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors.
Device: 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.




Primary Outcome Measures :
  1. % of assigned days with confirmed use [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Diary measured Off time [ Time Frame: 5 months ]
  2. Diary measured On time with dyskinesia [ Time Frame: 5 months ]
  3. Off time as measured by Kinesia 360 [ Time Frame: 5 months ]
  4. On time with dyskinesia as measured by Kinesia 360 [ Time Frame: 5 months ]
  5. PDQ-39 responses [ Time Frame: 5 months ]
  6. Patient Assessment for Chronic Conditions (PACIC) responses [ Time Frame: 5 months ]
  7. Patient Activation Measure (PAM)-13 responses [ Time Frame: 5 months ]
  8. Number of clinic visits [ Time Frame: 5 months ]
  9. Number of patient/investigator communications [ Time Frame: 5 months ]
  10. Unified Parkinson's disease rating scale (UPDRS) [ Time Frame: 5 months ]
  11. Duration of time with patient [ Time Frame: 5 months ]
  12. Number and type of medication changes [ Time Frame: 5 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657655


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21218
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
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
Investigators
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Principal Investigator: Dustin Heldman, PhD Great Lakes NeuroTechnologies Inc.

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Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT02657655     History of Changes
Other Study ID Numbers: GLNT-K360-1
5R44AG044293-04 ( U.S. NIH Grant/Contract )
5R44AG033947-05 ( U.S. NIH Grant/Contract )
Pro000048239 ( Other Identifier: IRB of the Greenville Health System )
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Keywords provided by Great Lakes NeuroTechnologies Inc.:
Parkinson's Disease
Dyskinesia
Tremor
Symptom Management
Technology
Wearable Sensors
Continuous Monitoring
Mobility

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases