Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (NCT03741920)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (6 items).
Location: Sutter Health — Sacramento, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (12 Sites)
- Sutter Health — Sacramento, California
- University of California — San Diego, California
- Parkinson's Disease and Movement Disorders Center — Boca Raton, Florida
- University of Florida — Gainesville, Florida
- University of Miami — Miami, Florida
- University of South Florida — Tampa, Florida
- University of Kansas Medical Center — Kansas City, Kansas
- Johns Hopkins Medical Institute — Baltimore, Maryland
- Michigan State University — East Lansing, Michigan
- Northwell Health — Great Neck, New York
- New York University — New York, New York
- University of Texas — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.