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

NCT03984305 | Terminated Results FDA Device

• 1 other identifier: Study 003
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 17

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).

Conditions

Parkinson Disease

Keywords

Personal KinetiGraph (PKG) Movement Recording System; Objective Measurement

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (13)

• Percentage of Responders for Total MDS-UPDRS

  4 month Follow-up Visit

• 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 MDS-UPDRS Total From Baseline

  From Baseline to the 1, 2 and 3-Year Annual Visits

• Change in MDS-UPDRS Sub Part I

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

• Change in PKG Bradykinesia Score (BKS)

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

Study Arms (2)

PKG+ Group

EXPERIMENTAL

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.

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

PKG- Group

PLACEBO COMPARATOR

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.

Device: Personal KinetiGraph® (PKG®) Watch

Interventions

Personal KinetiGraph® (PKG®) Watch DEVICE

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.

PKG+ Group; PKG- Group

Personal KinetiGraph® (PKG®) Report DEVICE

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.

PKG+ Group

Eligibility Criteria

• Age: 46 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Global Kinetics Corporation: lead

Study Sites (17)

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

Location

University of Arkansas Medical Center

Little Rock, Arkansas, 72205, United States

Location

Parkinson's Disease and Movement Disorders Center of Silicon Valley

Menlo Park, California, 94025, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kaiser Mid-Atlantic Permanente Center

Rockville, Maryland, 20852, United States

Location

Neurology Center of New England

Foxborough, Massachusetts, 02035, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Location

Parkinson's Disease and Movement Disorders Center of Long Island

Commack, New York, 11725, United States

Location

Weill Cornell

New York, New York, 10021, United States

Location

University of Texas

Houston, Texas, 77030, United States

Location

Marshall University

Huntington, West Virginia, 25701, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• 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.

  PMID: 30032695 BACKGROUND

• 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.

  PMID: 20065131 BACKGROUND

Related Links

• Sponsor website

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Global Kinetics Corporation

karen.krygier@globalkineticscorp.com

612.240.2437

Study Officials

• Raja Mehanna, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will remain blinded to treatment group throughout the life of the trial. Investigator and research staff will be unblinded to the treatment group as they will or will not have access to the PKG results to be incorporated into their standard of care practice.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects will be randomized using the Electronic Data Capture (EDC) system in a 1:1 ratio to the PKG- Group (standard of care clinical assessments without use of PKG data) or the PKG+ Group (standard of care clinical assessments plus use of PKG data).

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 13, 2019
• Study Start: October 15, 2019
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: February 8, 2022
• Results First Posted: February 8, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)