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Utilization of Target Ranges to Treat Parkinson's Disease With the PKG

NCT03984305 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-02-08

Study results available
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Summary

The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).

Conditions

  • Parkinson Disease

Interventions

DEVICE

Personal KinetiGraph® (PKG®) Watch

The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: * A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. * An application to configure the data logger and transfer the acquired data at the end of a recording.

DEVICE

Personal KinetiGraph® (PKG®) Report

The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.

Sponsors & Collaborators

  • Global Kinetics Corporation

    lead INDUSTRY

Principal Investigators

  • Raja Mehanna, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
46 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2020-10-16
Completion
2020-10-16
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03984305 on ClinicalTrials.gov