Overview

This trial is active, not recruiting.

Condition parkinson's disease
Treatment kinesia 360
Sponsor Great Lakes NeuroTechnologies Inc.
Collaborator University of South Carolina School of Medicine, Greenville
Start date January 2016
End date February 2017
Trial size 45 participants
Trial identifier NCT02657655, 5R44AG033947-05, 5R44AG044293-04, GLNT-K360-1, Pro000048239

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors.
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 Outcomes

Measure
% of assigned days with confirmed use
time frame: 5 months

Secondary Outcomes

Measure
Diary measured Off time
time frame: 5 months
Diary measured On time with dyskinesia
time frame: 5 months
Off time as measured by Kinesia 360
time frame: 5 months
On time with dyskinesia as measured by Kinesia 360
time frame: 5 months
PDQ-39 responses
time frame: 5 months
Patient Assessment for Chronic Conditions (PACIC) responses
time frame: 5 months
Patient Activation Measure (PAM)-13 responses
time frame: 5 months
Number of clinic visits
time frame: 5 months
Number of patient/investigator communications
time frame: 5 months
Unified Parkinson's disease rating scale (UPDRS)
time frame: 5 months
Duration of time with patient
time frame: 5 months
Number and type of medication changes
time frame: 5 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Kinesia 360 Multi-Center Parkinson's Monitoring Study
Principal investigator Dustin Heldman, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Great Lakes NeuroTechnologies Inc..