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

Not Applicable

Terminated

Conditions: Parkinson Disease

Interventions: Device: Personal KinetiGraph® (PKG®) Watch
Device: Personal KinetiGraph® (PKG®) Report

Registration Number: NCT03984305

Lead Sponsor: 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).

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).

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 41

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PKG- Group	Personal KinetiGraph® (PKG®) Watch	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.
PKG+ Group	Personal KinetiGraph® (PKG®) Report	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.
PKG+ Group	Personal KinetiGraph® (PKG®) Watch	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.

Primary Outcome Measures

Name	Time	Method
Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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 Outcome Measures

Name	Time	Method
Change in PKG Percent Time Tremor (PTT)	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%
PKG Patient Survey	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 Parkinson's Disease Questionnaire-39 Questions (PDQ-39)	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 PKG Dyskinesia Score (DKS)	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)	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 MDS-UPDRS Sub Part III	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	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).
Percentage of Responders for Total MDS-UPDRS	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 MDS-UPDRS Sub Part I	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)	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 MDS-UPDRS Total From Baseline	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 Levodopa Equivalent Dose (LED)	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)	Change in LED from baseline to 4-months
Change in MDS-UPDRS Sub Part II	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).

Trial Locations

Locations (17): Washington Regional Medical Center
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Fayetteville, Arkansas, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
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Boca Raton, Florida, United States
Parkinson's Disease and Movement Disorders Center of Silicon Valley
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Menlo Park, California, United States
Kaiser Mid-Atlantic Permanente Center
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Rockville, Maryland, United States
Neurology Center of New England
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Foxboro, Massachusetts, United States
Michigan State University
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East Lansing, Michigan, United States
Parkinson's Disease and Movement Disorders Center of Long Island
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Commack, New York, United States
Weill Cornell
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New York, New York, United States
Marshall University
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Huntington, West Virginia, United States
University of Texas
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Houston, Texas, United States
University of Arkansas Medical Center
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Little Rock, Arkansas, United States
University of South Florida
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Tampa, Florida, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
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Las Vegas, Nevada, United States
University of Florida
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Gainesville, Florida, United States
University of Nebraska
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Omaha, Nebraska, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, United States
University of Kansas Medical Center
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Kansas City, Kansas, United States