Clinical trial NCT02657655: Kinesia 360 Parkinson's Monitoring Study
Official title: Kinesia 360 Multi-Center Parkinson's Monitoring Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Dyskinesia
Tremor
Symptom Management
Technology
Wearable Sensors
Continuous Monitoring
Mobility
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of South Carolina School of Medicine, Greenville
name: University of Rochester
name: Johns Hopkins University
name: Prisma Health-Upstate
name: National Institute on Aging (NIA)
name: The Cleveland Clinic
First posted: 2016-01-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: % of assigned days with confirmed use
timeFrame: 5 months
Secondary outcomes:
measure: Diary measured Off time
timeFrame: 5 months
measure: Diary measured On time with dyskinesia
timeFrame: 5 months
measure: Off time as measured by Kinesia 360
timeFrame: 5 months
measure: On time with dyskinesia as measured by Kinesia 360
timeFrame: 5 months
measure: PDQ-39 responses
timeFrame: 5 months
measure: Patient Assessment for Chronic Conditions (PACIC) responses
timeFrame: 5 months
measure: Patient Activation Measure (PAM)-13 responses
timeFrame: 5 months
measure: Number of clinic visits
timeFrame: 5 months
measure: Number of patient/investigator communications
timeFrame: 5 months
measure: Unified Parkinson's disease rating scale (UPDRS)
timeFrame: 5 months
measure: Duration of time with patient
timeFrame: 5 months
measure: Number and type of medication changes
timeFrame: 5 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
Study officials:
affiliation: Great Lakes NeuroTechnologies Inc.
name: Dustin Heldman, PhD
role: PRINCIPAL_INVESTIGATOR
References: