Kinesia 360 Parkinson's Monitoring Study

Parkinson's Disease Clinical Trial

Official title:

Kinesia 360 Multi-Center Parkinson's Monitoring Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657655
• Other study ID #: GLNT-K360-1
• Secondary ID: 5R44AG044293-045
• Status: Completed
• Phase: N/A
• First received: January 14, 2016
• Last updated: February 15, 2018
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2018
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Cleveland Clinic	Cleveland	Ohio
United States	Greenville Health System	Greenville	South Carolina
United States	University of Rochester	Rochester	New York

Sponsors (7)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.	Greenville Health System, Johns Hopkins University, National Institute on Aging (NIA), The Cleveland Clinic, University of Rochester, University of South Carolina School of Medicine, Greenville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of assigned days with confirmed use		5 months
Secondary	Diary measured Off time		5 months
Secondary	Diary measured On time with dyskinesia		5 months
Secondary	Off time as measured by Kinesia 360		5 months
Secondary	On time with dyskinesia as measured by Kinesia 360		5 months
Secondary	PDQ-39 responses		5 months
Secondary	Patient Assessment for Chronic Conditions (PACIC) responses		5 months
Secondary	Patient Activation Measure (PAM)-13 responses		5 months
Secondary	Number of clinic visits		5 months
Secondary	Number of patient/investigator communications		5 months
Secondary	Unified Parkinson's disease rating scale (UPDRS)		5 months
Secondary	Duration of time with patient		5 months
Secondary	Number and type of medication changes		5 months