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

Global Kinetics Corporation41 enrolled

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).

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Parkinson Disease

Interventions

Personal KinetiGraph® (PKG®) WatchDEVICE

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.

Personal KinetiGraph® (PKG®) ReportDEVICE

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.

Eligibility

Sex: ALLMin age: 46 YearsMax age: 83 Years

Medical Language ↔ Plain English

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)

Locations (17)

Washington Regional Medical Center

Fayetteville, Arkansas, United States

University of Arkansas Medical Center

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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).

Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)

Secondary Outcomes

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.)

Time frame: 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.

Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)

Change in MDS-UPDRS Total From Baseline

Data from ClinicalTrials.gov

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Parkinson's Disease and Movement Disorders Center of Silicon Valley

Menlo Park, California, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

University of Florida

Gainesville, Florida, United States

University of South Florida

Tampa, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Kaiser Mid-Atlantic Permanente Center

Rockville, Maryland, United States

Neurology Center of New England

Foxborough, Massachusetts, United States

Michigan State University

East Lansing, Michigan, United States

...and 7 more locations

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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%

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: From Baseline to the 4-month Follow-up Visit