Kinesia 360 Parkinson's Monitoring Study

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: Kinesia 360

• Registration Number: NCT02657655
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kinesia 360 Users	Kinesia 360	Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors.

Primary Outcome Measures

Name	Time	Method
% of assigned days with confirmed use	5 months

Secondary Outcome Measures

Name	Time	Method
Diary measured Off time	5 months
Unified Parkinson's disease rating scale (UPDRS)	5 months
Duration of time with patient	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 Activation Measure (PAM)-13 responses	5 months
Number of patient/investigator communications	5 months
Diary measured On time with dyskinesia	5 months
Patient Assessment for Chronic Conditions (PACIC) responses	5 months
Number of clinic visits	5 months
Number and type of medication changes	5 months

Trial Locations

Locations (4)

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States