Kinesia 360 Parkinson's Monitoring Study

Kinesia 360 Multi-Center Parkinson's Monitoring Study

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Kinesia 360

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% of assigned days with confirmed use	5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Diary measured Off time	5 months
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
Patient Activation Measure (PAM)-13 responses	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

Collaborators and Investigators

• Sponsor: Great Lakes NeuroTechnologies Inc.
• Collaborators: Johns Hopkins University; The Cleveland Clinic; National Institute on Aging (NIA); University of Rochester; Prisma Health-Upstate; University of South Carolina School of Medicine, Greenville
• Investigators: Principal Investigator: Dustin Heldman, PhD, Great Lakes NeuroTechnologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Mobility; Tremor; Technology; Wearable Sensors; Dyskinesia; Symptom Management; Continuous Monitoring
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• 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)