Utilization of Target Ranges to Treat Parkinson's Disease With the PKG
NCT ID: NCT03984305
Last Updated: 2022-02-08
Study Results
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View full resultsBasic Information
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TERMINATED
NA
41 participants
INTERVENTIONAL
2019-10-15
2020-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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PKG+ Group
For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG.
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.
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.
PKG- Group
For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Presumed to have Levodopa responsive idiopathic Parkinson's Disease
* Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)
* Has not been previously managed with the PKG
Exclusion Criteria
* MoCA score \<23 at screening visit
* Diagnosis of Essential Tremor
* Wheelchair bound or bedridden
* Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.)
* In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints (e.g., subject unable to complete PKG watch wear instructions per Patient Instruction Manual)
46 Years
83 Years
ALL
No
Sponsors
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Global Kinetics Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Raja Mehanna, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Washington Regional Medical Center
Fayetteville, Arkansas, United States
University of Arkansas Medical Center
Little Rock, Arkansas, United States
Parkinson's Disease and Movement Disorders Center of Silicon Valley
Menlo Park, California, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
University of Florida
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kaiser Mid-Atlantic Permanente Center
Rockville, Maryland, United States
Neurology Center of New England
Foxborough, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
University of Nebraska
Omaha, Nebraska, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, United States
Weill Cornell
New York, New York, United States
University of Texas
Houston, Texas, United States
Marshall University
Huntington, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Pahwa R, Isaacson SH, Torres-Russotto D, Nahab FB, Lynch PM, Kotschet KE. Role of the Personal KinetiGraph in the routine clinical assessment of Parkinson's disease: recommendations from an expert panel. Expert Rev Neurother. 2018 Aug;18(8):669-680. doi: 10.1080/14737175.2018.1503948. Epub 2018 Jul 26.
Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Sponsor website
Other Identifiers
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Study 003
Identifier Type: -
Identifier Source: org_study_id
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