An interventional study of Personal KinetiGraph® (PKG®) System and Personal KinetiGraph® (PKG®) Watch in Parkinson Disease, sponsored by Global Kinetics Corporation. Withdrawn. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Global Kinetics Corporation · Not applicable, Interventional, and Diagnostic
The main objective of this study is to evaluate whether persons with Parkinson's disease (PwP) whose Parkinson's disease (PD) symptoms are uncontrolled have improved clinical patient outcomes and quality of life when managed with the aid of objective measurement and use of PKG target ranges compared to PwP treated using only standard of care (SOC) (medical history, physical examination).
This is a randomized controlled trial (RCT) to compare the value of the Personal KinetiGraph® (PKG®) System and SOC vs. the SOC alone for treatment of PwP. The study aims to evaluate clinical outcomes, quality of life outcomes, health economic benefits, duration of controlled status, and need for additional PD treatment through 3 years follow-up of PwP specifically treated to a target range when using the PKG data in the clinical management of PD in routine clinical care compared to those managed with SOC alone. All subjects will be treated by Movement Disorder Specialists and General Neurologists with expertise in PD. Both groups will be recommended to undergo treatment changes until they reach a "controlled state" that is determined by either the clinician using SOC (PKG- Group) or using recommended target ranges for PKG scores and SOC assessments (PKG+ Group). Investigators will utilize standard available treatments to manage these PwP in both groups.
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Exclusion Criteria:
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 in the target range or out of the target range based on scores provided by the PKG.
Device: Personal KinetiGraph® (PKG®) System
For subjects in the PKG- 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®) System consists of the following: * A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period * Proprietary algorithms to translate raw movement data collected by the PKG® Watch * Data-driven report known as the PKG® The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® also provides an assessment of daytime somnolence and an indication of propensity for impulsive behaviors.
The Personal KinetiGraph (PKG®) System consists of the following: * A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period * Proprietary algorithms to translate raw movement data collected by the PKG® Watch
Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The change in MDS-UPDRS Total score at 4 months from baseline defined as sections I, II, III (per core lab measurement) and IV in PwP. The endpoint will be compared between subjects out of target at baseline for those who are treated with SOC and PKG data (PKG+ Group) versus those who are treated per SOC alone (PKG- Group).
Time frame: 4 months
Responder rate for total MDS-UPDRS
Percent "responders" for total MDS-UPDRS based on a minimal clinically important change of \>4 points (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.). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (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: 4 months
Responder rate for PKG
Percent "responders" by PKG (defined as BKS change of \>2 point improvement)
Time frame: 4 months
Change in MDS-UPDRS motor endpoints
Change in MDS-UPDRS Part III (per core lab measurement). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Part III is the motor examination and contains 33 questions/evaluations. 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: 4 months, 1 year, 2 years, 3 years
Change in MDS-UPDRS total
Change in MDS-UPDRS Total score from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (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: 1 year, 2 years, 3 years
Change in MDS-UPDRS sub parts
Change in the non-motor (parts I and II) score and change in Part IV for the MDS-UPDRS from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (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: 4 months, 1 year, 2 years, 3 years
Change in PKG Bradykinesia Score (BKS)
Change in the PKG reported BKS from baseline. A higher score represents more severe bradykinesia.
Time frame: 4 months, 1 year, 2 years, 3 years
Change in PKG Dyskinesia score (DKS)
Change in the PKG reported DKS from baseline. A higher score represents more severe dyskinesia.
Time frame: 4 months, 1 year, 2 years, 3 years
Change in Percent Time in Tremor (PTT)
Change in the PKG reported PTT from baseline, max 100%. A PTT of \>1% indicates that tremor is present.
Time frame: 4 months, 1 year, 2 years, 3 years
Change in Fluctuation Dyskinesia score (FDS)
Change in the PKG reported FDS from baseline. The higher the score, the more severe the fluctuation, and a FDS of 7.5-13 indicates controlled fluctuations.
Time frame: 4 months, 1 year, 2 years, 3 years
Change in Percent Time Immobile (PTI)
Change in the PKG reported PTI from baseline, max 100%. A PTI of \>5% is considered high.
Time frame: 4 months, 1 year, 2 years, 3 years
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: 4 months, 1 year, 2 years, 3 years
Number of Interim Visits
Number of interim visits conducted from baseline to 4 months in each arm
Time frame: 4 months
Levodopa Equivalent Dose (LED)
Levodopa Equivalent Dose (LED) at each visit
Time frame: 4 months, 1 year, 2 years, 3 years
PKG Patient Survey
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.
Time frame: 4 months, 1 year, 2 years, 3 years
Healthcare Utilization
Rate of protocol defined adverse events affecting health care utilization from baseline
Time frame: 4 months, 1 year, 2 years, 3 years
Potential Contraindications
Rate of protocol defined adverse events and potential contraindications for increasing dopaminergic therapy from baseline
Time frame: 4 months, 1 year, 2 years, 3 years
Lifestyle Factors Impacted by PD
Rate of protocol defined lifestyle factors impacted by PD
Time frame: 4 months, 1 year, 2 years, 3 years
Work Productivity and Activity Impairment
Change in Work Productivity and Activity Impairment Questionnaire (WPAI) from baseline. The WPAI Questionnaire includes questions regarding impacts to work productivity due to PD symptoms.
Time frame: 4 months, 1 year, 2 years, 3 years
PKG scores
Proportion of enrolled subjects in PKG+ group who are either unable to be brought into the target range or unable to be brought to a BKS ≤26. A higher score represents more severe bradykinesia.
Time frame: 4 months, 1 year, 2 years, 3 years
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This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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