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

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ClinicalTrials.gov Identifier: NCT03984305
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Global Kinetics Corporation

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).

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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
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  • 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)

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): NCT03984305


Contacts
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Contact: Julie W Wolfram Smith, PhD MBA 6125092484 julie.wolframsmith@globalkineticscorp.com
Contact: Karen Krygier, MBA 612-240-2437 karen.krygier@globalkineticscorp.com

Locations
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United States, Maryland
Kaiser Mid-Atlantic Permanente Center Not yet recruiting
Rockville, Maryland, United States, 20852
Contact: Ejaz Shamim, MD         
United States, Massachusetts
Neurology Center of New England Not yet recruiting
Foxboro, Massachusetts, United States, 02035
Contact: Elizabeth Budman, MD         
United States, Nebraska
University of Nebraska Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Danish Bhatti, MD         
United States, New York
Parkinson's Disease and Movement Disorders Center of Long Island Not yet recruiting
Commack, New York, United States, 11725
Contact: David Kreitzman, MD         
Weill Cornell Not yet recruiting
New York, New York, United States, 10021
Contact: Andrea Lee, MD         
United States, Texas
University of Texas
Houston, Texas, United States, 77030
United States, West Virginia
Marshall University Not yet recruiting
Huntington, West Virginia, United States, 25701
Contact: Vikram Shivkumar, MD         
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Ryan Brennan, DO         
Sponsors and Collaborators
Global Kinetics Corporation
Investigators
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Principal Investigator: Raja Mehanna, MD The University of Texas Health Science Center, Houston

Additional Information:
Publications:
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Responsible Party: Global Kinetics Corporation
ClinicalTrials.gov Identifier: NCT03984305     History of Changes
Other Study ID Numbers: Study 003
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

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