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Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG

NCT04381065 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-02-01

No results posted yet for this study

Summary

The main objective of this study is to evaluate whether persons with Parkinson's disease (PwP) whose Parkinson's disease (PD) symptoms are uncontrolled have improved clinical patient outcomes and quality of life when managed with the aid of objective measurement and use of PKG target ranges compared to PwP treated using only standard of care (SOC) (medical history, physical examination).

Conditions

  • Parkinson Disease

Interventions

DEVICE

Personal KinetiGraph® (PKG®) System

The Personal KinetiGraph (PKG®) System consists of the following: * A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period * Proprietary algorithms to translate raw movement data collected by the PKG® Watch * Data-driven report known as the PKG® The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® also provides an assessment of daytime somnolence and an indication of propensity for impulsive behaviors.

DEVICE

Personal KinetiGraph® (PKG®) Watch

The Personal KinetiGraph (PKG®) System consists of the following: * A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period * Proprietary algorithms to translate raw movement data collected by the PKG® Watch

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
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2022-04-30
Completion
2026-04-30
FDA Device
Yes

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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 NCT04381065 on ClinicalTrials.gov