Parkinson Disease Clinical Trial
— APPRISEOfficial title:
Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)
Verified date | March 2023 |
Source | Global Kinetics Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 231 |
Est. completion date | December 2024 |
Est. primary completion date | February 18, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 46 Years to 83 Years |
Eligibility | Inclusion Criteria: - 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 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) |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Medical Institute | Baltimore | Maryland |
United States | Parkinson's Disease and Movement Disorders Center | Boca Raton | Florida |
United States | Michigan State University | East Lansing | Michigan |
United States | University of Florida | Gainesville | Florida |
United States | Northwell Health | Great Neck | New York |
United States | University of Texas | Houston | Texas |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of Miami | Miami | Florida |
United States | New York University | New York | New York |
United States | Sutter Health | Sacramento | California |
United States | University of California | San Diego | California |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Global Kinetics Corporation |
United States,
Maetzler W, Klucken J, Horne M. A clinical view on the development of technology-based tools in managing Parkinson's disease. Mov Disord. 2016 Sep;31(9):1263-71. doi: 10.1002/mds.26673. Epub 2016 Jun 7. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of treatment changes with or without the use of PKG data | The proportion of patients in which the clinical management plan was changed in patients followed in the PKG- Group (clinician standard of care) compared to the PKG+ Group (clinician standard of care with the use of PKG data). | 90 day |
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