Utilization of Target Ranges to Treat Parkinson's Disease With the PKG (TARGET-PD)
Parkinson Disease
About this trial
This is an interventional supportive care trial for Parkinson Disease focused on measuring Personal KinetiGraph (PKG) Movement Recording System, Objective Measurement
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Washington Regional Medical Center
- University of Arkansas Medical Center
- Parkinson's Disease and Movement Disorders Center of Silicon Valley
- Parkinson's Disease and Movement Disorders Center of Boca Raton
- University of Florida
- University of South Florida
- University of Kansas Medical Center
- Kaiser Mid-Atlantic Permanente Center
- Neurology Center of New England
- Michigan State University
- University of Nebraska
- Cleveland Clinic Lou Ruvo Center for Brain Health
- Parkinson's Disease and Movement Disorders Center of Long Island
- Weill Cornell
- University of Texas
- Marshall University
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
PKG+ Group
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 "controlled" or "uncontrolled" based on scores provided by the PKG.
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.