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Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)

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ClinicalTrials.gov Identifier: NCT03741920
Recruitment Status : Enrolling by invitation
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Global Kinetics Corporation

Brief Summary:

The primary objective is to understand the utility of Personal KinetiGraph movement recording system data in the clinical management of Parkinson's disease (PD) in routine clinical care at a movement disorders clinic. Specifically:

  1. Measure medication use and clinical management plan changes in a large, multicenter cohort among participants undergoing a clinical assessment with an MDS in which the MDS reviews the participant's PKG during the clinical assessment in half of the enrolled participants (PKG + Group) and in half of the enrolled participants the MDS completes the clinical assessment without the PKG (PKG- Group).
  2. Determine the association between frequency of medication changes, the PKG information, and other clinical assessments among participants with and without a PKG report of their PD motor status available to the clinician at the time of evaluation.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Personal KinetiGraph™ (PKG™) Not Applicable

Detailed Description:

This is a prospective, multicenter, randomized controlled trial. The study consists of 3 phases as follows:

  • Randomization phase: subjects undergo screening, baseline, interim and 90-day follow-up visits

    • PKG+ Group (standard of care clinical evaluation plus use of PKG data)
    • PKG- Group (standard of care clinical evaluation without use of PKG data - the MDS is blinded to PKG data)
    • Randomization ratio will be 1:1 with assignments generated in advance of the start of the trial by the unblinded statistician who will provide a list containing group assignments that will be available in an Electronic Database (EDC) for site use.
    • The clinical investigator, study site staff, and subject will not be blinded to the randomization assignment during the randomization phase of the study
  • Open-label phase: at the end of the 90-day randomization phase visit for PKG- Group subjects, the MDS will report on the PKG and review it with the subject, the subject will complete follow-ups with the MDS using the PKG information during the clinical assessment following the same process as the PKG+ Group during the randomization phase
  • Extended open-label follow-up phase: annual follow-ups for all subjects at 1, 2, and 3 years during which the MDS will use the PKG information during clinical assessments for all subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personal KinetiGraph™ (PKG™) +
For subjects in the PKG+ Group, the study MDS 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. PKG results will be recorded in the PKG Reporting case report form (CRF). The study MDS will complete the MDS-Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures along with the PKG information.
Device: Personal KinetiGraph™ (PKG™)

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 Global Kinetics (GKC).

The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following:

  • A wrist-worn data logger 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.
  • A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.

Active Comparator: Personal KinetiGraph™ (PKG™) -
For subjects in the PKG- Group (control group), the study Movement Disorder Specialist (MDS) will complete the MDS - Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures. The study Movement Disorder Specialist will be blinded to the PKG information until the second part of the 90-day follow-up visit.
Device: Personal KinetiGraph™ (PKG™)

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 Global Kinetics (GKC).

The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following:

  • A wrist-worn data logger 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.
  • A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.




Primary Outcome Measures :
  1. Evaluation of treatment changes with or without the use of PKG data [ Time Frame: 90 day ]
    The proportion of patients in which the clinical management plan was changed in patients followed in the PKG- Group (clinician standard of care) compared to the PKG+ Group (clinician standard of care with the use of PKG data).



Information from the National Library of Medicine

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Ages Eligible for Study:   46 Years to 83 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to sign a written informed consent for study participation
  • Age 46 - 83 years at the time of consent (per PKG Indications for Use, see Technical Instructions Manual)
  • Responsive to dopaminergic medications

Exclusion Criteria:

  • Contraindication to increasing dopaminergic therapy, such as current or treated freezing gait, symptomatic postural hypotension, or bothersome hallucinations
  • Wheelchair bound or bedridden
  • Utilizing or planning advanced PD therapies (DBS, infusion, etc.)
  • History of delirium in the past year
  • 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 able to complete PKG wear instructions per Patient Instruction Manual, or ability to comply with required study procedures and visit schedule)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741920


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32604
University of Miami
Miami, Florida, United States, 33136
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
United States, Maryland
Johns Hopkins Medical Institute
Baltimore, Maryland, United States, 21287
United States, New York
New York University
New York, New York, United States, 10017
Sponsors and Collaborators
Global Kinetics Corporation
Investigators
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Principal Investigator: Rajesh Pahwa, MD University of Kansas Medical Center

Publications:
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Responsible Party: Global Kinetics Corporation
ClinicalTrials.gov Identifier: NCT03741920     History of Changes
Other Study ID Numbers: Study 002
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Global Kinetics Corporation:
Personal KinetiGraph (PKG) Movement Recording System

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases