Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status

Running, not enrolling · Not applicable

Conditions studied: Parkinson Disease

In brief

The primary objective is to understand the utility of Personal KinetiGraph movement recording system data in the clinical management of Parkinson's disease (PD) in routine clinical care at a movement disorders clinic. Specifically: 1. Measure medication use and clinical management plan changes in a large, multicenter cohort among participants undergoing a clinical assessment with an MDS in which the MDS reviews the participant's PKG during the clinical assessment in half of the enrolled participants (PKG + Group) and in half of the enrolled participants the MDS completes the clinical assessment without the PKG (PKG- Group). 2. Determine the association between frequency of medication changes, the PKG information, and other clinical assessments among participants with and without a PKG report of their PD motor status available to the clinician at the time of evaluation.

Key facts

Study ID

NCT03741920

Run by

Global Kinetics Corporation

People needed

231

Starts

2017-05-17

Expected to finish

2025-10-01

Last updated by the study team

2025-09-04

Who can join

Age: 46 and older, up to 83. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to sign a written informed consent for study participation
• Age 46 - 83 years at the time of consent (per PKG Indications for Use, see Technical Instructions Manual)
• Responsive to dopaminergic medications

You may not qualify if…

• Contraindication to increasing dopaminergic therapy, such as current or treated freezing gait, symptomatic postural hypotension, or bothersome hallucinations
• Wheelchair bound or bedridden
• Utilizing or planning advanced PD therapies (DBS, infusion, etc.)
• History of delirium in the past year
• 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 able to complete PKG wear instructions per Patient Instruction Manual, or ability to comply with required study procedures and visit schedule)

Where it is running

• Sutter Health — Sacramento, California, United States
• University of California — San Diego, California, United States
• Parkinson's Disease and Movement Disorders Center — Boca Raton, Florida, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins Medical Institute — Baltimore, Maryland, United States
• Michigan State University — East Lansing, Michigan, United States
• Northwell Health — Great Neck, New York, United States
• New York University — New York, New York, United States
• University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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