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

Overview

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).

Full Title of Study: “Utilization of Target Ranges to Treat Patients With Parkinson’s Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PD)- A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 16, 2020

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).

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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Patient Outcomes Using Movement Disorder Specialist – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson’s. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson’s and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson’s disease symptoms (i.e., worse symptoms).

Secondary Measures

  • Percentage of Responders for Total MDS-UPDRS
    • Time Frame: 4 month Follow-up Visit
    • Percent “responders” for total MDS-UPDRS based on a minimal clinically important change of 4.3 (Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The Clinically Important Difference on the Unified Parkinson’s Disease Rating Scale. Arch Neurol 2010: 67(1):64-70.)
  • Change in Parkinson’s Disease Questionnaire-39 Questions (PDQ-39)
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • Change in the patient reported quality of life questionnaire PDQ-39 from Baseline. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson’s disease-specific health related quality of life issues across 8 dimensions. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.
  • Change in MDS-UPDRS Total From Baseline
    • Time Frame: From Baseline to the 1, 2 and 3-Year Annual Visits
    • The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson’s. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson’s and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson’s disease symptoms (i.e., worse symptoms).
  • Change in MDS-UPDRS Sub Part I
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • Change in sub part I of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson’s and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part I assesses the non-motor impact of Parkinson’s disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part I is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson’s disease symptoms (i.e., worse symptoms).
  • Change in PKG Bradykinesia Score (BKS)
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • Change in the PKG reported scores BKS from baseline. Reported on a scale from 0-80. The higher the number, the more severe the bradykinesia.
  • Change in PKG Dyskinesia Score (DKS)
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • Change in the PKG reported scores DKS from baseline. Reported on a scale of 0-355 with the higher the score, the more severe the dyskinesia.
  • Change in PKG Fluctuation Score (FDS)
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • Change in the PKG reported scores FDS from baseline reported as a score of 0-45. The higher the score, the more severe the fluctuation.
  • Change in PKG Percent Time Tremor (PTT)
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • Change in the PKG reported percent time in tremor from baseline, max 100%
  • Change in Levodopa Equivalent Dose (LED)
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • Change in LED from baseline to 4-months
  • PKG Patient Survey
    • Time Frame: Outcome measure evaluated at the 4-month Follow-up Visit
    • Analyze PKG usability with the PKG Patient reported survey, specifically the percentage of subjects that strongly agree when asked if they would be willing to use the PKG again to assist in the management of Parkinson’s disease. Questions in the survey are on a scale of strongly agree to strongly disagree and will be patient reported information related to their use of the PKG watch. Both treatment groups will be administered the survey and scores will be aggregated by group and compared.
  • Change in MDS-UPDRS Sub Part II
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • Change in sub part II of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson’s and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part II assesses the non-motor impact of Parkinson’s disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part II is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson’s disease symptoms (i.e., worse symptoms).
  • Change in MDS-UPDRS Sub Part III
    • Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
    • Change in sub part III of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson’s and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part III assesses the motor impact of Parkinson’s disease and contains 33 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part III is 0 and the maximum score is 132. Higher scores indicate a greater impact of Parkinson’s disease symptoms (i.e., worse symptoms).
  • Change in MDS-UPDRS Sub Part IV
    • Time Frame: From Baseline to the 4-month Follow-up Visit
    • Change in Part IV of the MDS-UPDRS from Baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson’s and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part IV evaluates motor symptoms and contains 6 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part IV is 0 and the maximum score is 24. Higher scores indicate a greater impact of Parkinson’s disease symptoms (i.e., worse symptoms).

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 46 Years

Maximum Age: 83 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Global Kinetics Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Raja Mehanna, MD, Principal Investigator, The University of Texas Health Science Center, Houston

References

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.

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