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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Personal KinetiGraph® (PKG®) Watch
* Device: Personal KinetiGraph® (PKG®) Report


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 46 Years
Maximum Age: 83 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PKG+ Group<br>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<br>* 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.<br>Device: Personal KinetiGraph® (PKG®) Report<br>* 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.<br>|
| Placebo Comparator: PKG- Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 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). | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders for Total MDS-UPDRS | 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.) | 4 month Follow-up Visit | 
| Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39) | 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. | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 
| Change in MDS-UPDRS Total From Baseline | 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). | From Baseline to the 1, 2 and 3-Year Annual Visits | 
| Change in MDS-UPDRS Sub Part I | 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). | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 
| Change in PKG Bradykinesia Score (BKS) | 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. | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 
| Change in PKG Dyskinesia Score (DKS) | 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. | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 
| Change in PKG Fluctuation Score (FDS) | 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. | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 
| Change in PKG Percent Time Tremor (PTT) | Change in the PKG reported percent time in tremor from baseline, max 100% | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 
| Change in Levodopa Equivalent Dose (LED) | Change in LED from baseline to 4-months | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 
| PKG Patient Survey | 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. | Outcome measure evaluated at the 4-month Follow-up Visit | 
| Change in MDS-UPDRS Sub Part II | 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). | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 
| Change in MDS-UPDRS Sub Part III | 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). | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 
| Change in MDS-UPDRS Sub Part IV | 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). | From Baseline to the 4-month Follow-up Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personal KinetiGraph (PKG) Movement Recording System, Objective Measurement