Purpose

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).

Condition

Eligibility

Eligible Ages
Between 46 Years and 83 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Able and willing to sign a written informed consent for study participation
  • 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

  • Contraindication to increasing levodopa (e.g. orthostatic hypotension, hallucinations/psychosis or any other medical condition in the last year that would preclude increasing levodopa or other appropriate Parkinson's Disease medications)
  • 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Eligible subjects will be randomized using the Electronic Data Capture (EDC) system in a 1:1 ratio to the PKG- Group (standard of care clinical assessments without use of PKG data) or the PKG+ Group (standard of care clinical assessments plus use of PKG data).
Primary Purpose
Supportive Care
Masking
Single (Participant)
Masking Description
Subjects will remain blinded to treatment group throughout the life of the trial. Investigator and research staff will be unblinded to the treatment group as they will or will not have access to the PKG results to be incorporated into their standard of care practice.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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.
Placebo Comparator
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.
  • 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.

Recruiting Locations

More Details

NCT ID
NCT03984305
Status
Enrolling by invitation
Sponsor
Global Kinetics Corporation

Detailed Description

This is a randomized controlled trial (RCT) to evaluate treating uncontrolled patients with Parkinson's Disease (PwP) to a target range as suggested by expert review papers. The study aims to evaluate clinical patient outcomes, quality of life measures and health care utilization of those patients specifically treated to a target range when using the PKG data in the clinical management of Parkinson's disease (PD) in routine clinical care (treatment group) compared to those managed with medical history and clinical evaluation alone (control group) performed by a neurologist experienced in PD management. Both groups will be recommended to undergo medication changes until they reach a "controlled state" that is determined by either the clinician using standard of care (SOC) (PKG- Group) or using PKG based targets and SOC assessments (PKG+ Group).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.