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

Stopped early · Not applicable

Conditions studied: Parkinson Disease

In brief

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).

Key facts

Study ID

NCT03984305

Run by

Global Kinetics Corporation

People needed

41

Starts

2019-10-15

Expected to finish

2020-10-16

Last updated by the study team

2022-02-08

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
• 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)

Where it is running

• Washington Regional Medical Center — Fayetteville, Arkansas, United States
• University of Arkansas Medical Center — Little Rock, Arkansas, United States
• Parkinson's Disease and Movement Disorders Center of Silicon Valley — Menlo Park, California, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• University of Florida — Gainesville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Kaiser Mid-Atlantic Permanente Center — Rockville, Maryland, United States
• Neurology Center of New England — Foxborough, Massachusetts, United States
• Michigan State University — East Lansing, Michigan, United States
• University of Nebraska — Omaha, Nebraska, United States
• Cleveland Clinic Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States
• Parkinson's Disease and Movement Disorders Center of Long Island — Commack, New York, United States
• Weill Cornell — New York, New York, United States
• University of Texas — Houston, Texas, United States
• Marshall University — Huntington, West Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.