Kinesia 360 Parkinson's Monitoring Study

NCT02657655 | Completed

• 4 other identifiers: GLNT-K360-15R44AG044293-045R44AG033947-05Pro000048239
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Dyskinesia; Tremor; Symptom Management; Technology; Wearable Sensors; Continuous Monitoring; Mobility

Outcome Measures

Primary Outcomes (1)

• % of assigned days with confirmed use

  5 months

Secondary Outcomes (12)

• 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

Study Arms (1)

Kinesia 360 Users

EXPERIMENTAL

Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors.

Device: Kinesia 360

Interventions

Kinesia 360 DEVICE

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.

Kinesia 360 Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Great Lakes NeuroTechnologies Inc.: lead
• University of South Carolina School of Medicine, Greenville: collaborator
• University of Rochester: collaborator
• Johns Hopkins University: collaborator
• Prisma Health-Upstate: collaborator
• National Institute on Aging (NIA): collaborator
• The Cleveland Clinic: collaborator

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Greenville Health System

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias; Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dustin Heldman, PhD

  Great Lakes NeuroTechnologies Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 18, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

US (4)