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出境医 / 临床实验 / Utilization of Target Ranges to Treat Parkinson's Disease With the PKG (TARGET-PD)

Utilization of Target Ranges to Treat Parkinson's Disease With the PKG (TARGET-PD)

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson Disease Device: Personal KinetiGraph® (PKG®) Watch Device: Personal KinetiGraph® (PKG®) Report Not Applicable

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).
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
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).
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.
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : January 31, 2024
Arms and Interventions
Arm Intervention/treatment
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.
Outcome Measures
Primary Outcome Measures :
  1. Change in Patient Outcomes using MDS-UPDRS [ Time Frame: 4 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).


Secondary Outcome Measures :
  1. Responder rate for total MDS-UPDRS [ Time Frame: 4 months ]
    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.)

  2. Change in Parkinson's Disease Questionnaire-39 questions (PDQ-39) [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    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.

  3. Change in MDS-UPDRS total [ Time Frame: 1 year, 2 years, 3 years ]
    Change in the total score for the MDS-UPDRS from baseline

  4. Change in MDS-UPDRS sub parts [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Change in the non-motor (parts I and II) score, change in the motor score (part III) and change in Part IV for the MDS-UPDRS from baseline

  5. Change in PKG Bradykinesia score (BKS) [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    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.

  6. Change in PKG Dyskinesia score (DKS) [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    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.

  7. Change in PKG Fluctuation score (FDS) [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    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.

  8. Change in PKG Percent Time Tremor (PTT) [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Change in the PKG reported percent time in tremor from baseline, max 100%

  9. Change in Levodopa Equivalent Dose (LED) [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Change in LED from baseline to each interim visit

  10. PKG Patient Survey [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Analyze PKG usability with the PKG Patient reported survey. Questions 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.


Other Outcome Measures:
  1. Healthcare Utilization [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Rate of protocol defined adverse events affecting health care utilization from baseline

  2. Potential Contraindications [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Rate of protocol defined adverse events and potential contraindications for increasing dopaminergic therapy from baseline


Eligibility Criteria
Layout table for eligibility information
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
  • 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)
Contacts and Locations

Locations
Show Show 17 study locations
Sponsors and Collaborators
Global Kinetics Corporation
Investigators
Layout table for investigator information
Principal Investigator: Raja Mehanna, MD The University of Texas Health Science Center, Houston
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE October 15, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		Change in Patient Outcomes using MDS-UPDRS [ Time Frame: 4 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Responder rate for total MDS-UPDRS [ Time Frame: 4 months ]
    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: 4 months, 1 year, 2 years, 3 years ]
    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 [ Time Frame: 1 year, 2 years, 3 years ]
    Change in the total score for the MDS-UPDRS from baseline
  • Change in MDS-UPDRS sub parts [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Change in the non-motor (parts I and II) score, change in the motor score (part III) and change in Part IV for the MDS-UPDRS from baseline
  • Change in PKG Bradykinesia score (BKS) [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    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: 4 months, 1 year, 2 years, 3 years ]
    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: 4 months, 1 year, 2 years, 3 years ]
    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: 4 months, 1 year, 2 years, 3 years ]
    Change in the PKG reported percent time in tremor from baseline, max 100%
  • Change in Levodopa Equivalent Dose (LED) [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Change in LED from baseline to each interim visit
  • PKG Patient Survey [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Analyze PKG usability with the PKG Patient reported survey. Questions 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 11, 2019)
  • Healthcare Utilization [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Rate of protocol defined adverse events affecting health care utilization from baseline
  • Potential Contraindications [ Time Frame: 4 months, 1 year, 2 years, 3 years ]
    Rate of protocol defined adverse events and potential contraindications for increasing dopaminergic therapy from baseline
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Utilization of Target Ranges to Treat Parkinson's Disease With the PKG
Official Title  ICMJE 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
Brief Summary 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).
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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).
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.
Primary Purpose: Supportive Care
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Personal KinetiGraph® (PKG®) Watch
    • Device: Personal KinetiGraph® (PKG®) Report
  • 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.
    Intervention: Device: Personal KinetiGraph® (PKG®) Watch
Publications *
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2024
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 46 Years to 83 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984305
Other Study ID Numbers  ICMJE Study 003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Global Kinetics Corporation
Study Sponsor  ICMJE Global Kinetics Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raja Mehanna, MD The University of Texas Health Science Center, Houston
PRS Account Global Kinetics Corporation
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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