Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG

Global Kinetics Corporation

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Conditions

Parkinson Disease

Interventions

Personal KinetiGraph® (PKG®) SystemDEVICE

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.

Personal KinetiGraph® (PKG®) WatchDEVICE

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Able and willing to sign a written informed consent for study participation and comply with all required follow-up visits * Presumed to have levodopa responsive PD * Taking levodopa for at least 30 days prior to screening visit * Planning to continue using levodopa for PD throughout study participation * Able to increase levodopa by a minimum of 100mg/day * Age inclusive at the time of consent of 55-80 years * Has not received a PKG in the last 12 months Exclusion Criteria: * Evidence of atypical or secondary parkinsonism * Presence of any non-parkinsonian tremors * Contraindication to increasing levodopa * Requires the addition of or dose adjustment of an anti-dyskinesia medication within the next 4 months * Those who have received advanced therapies including individuals no longer actively utilizing these therapies, or planning to receive advanced therapies in the next 6 months * MoCA score \<23 at screening visit * Bedridden, wheelchair confined, or requires the regular use of an assistive gait device * Predominant sleep period is during the daytime hours of 9am to 6pm (e.g. third shift worker) * 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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