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

NCT ID: NCT04381065

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2026-04-30

Brief Summary

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).

Detailed Description

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

PKG+ Group

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.

Group Type: EXPERIMENTAL

Personal KinetiGraph® (PKG®) System

Intervention Type: DEVICE

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.

PKG- Group

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.

Group Type: PLACEBO_COMPARATOR

Personal KinetiGraph® (PKG®) Watch

Intervention Type: DEVICE

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

Interventions

Personal KinetiGraph® (PKG®) System

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Global Kinetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raja Mehanna, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

References

Pahwa R, Isaacson SH, Torres-Russotto D, Nahab FB, Lynch PM, Kotschet KE. Role of the Personal KinetiGraph in the routine clinical assessment of Parkinson's disease: recommendations from an expert panel. Expert Rev Neurother. 2018 Aug;18(8):669-680. doi: 10.1080/14737175.2018.1503948. Epub 2018 Jul 26.

Reference Type: BACKGROUND

PMID: 30032695 (View on PubMed)

Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.

Reference Type: BACKGROUND

PMID: 20065131 (View on PubMed)

Related Links

https://www.globalkineticscorporation.com/

Sponsor website

Other Identifiers

Study 004

Identifier Type: -

Identifier Source: org_study_id