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Evaluation of the Parkinson's KinetiGraph Data Logger (PKG) as a Tool to Measure Motor Fluctuations and Support the DBS Eligibility Assessment of Parkinson's Disease Patients.
The purpose of the study is to investigate the feasibility of using the commercially available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor fluctuations in Parkinson's Disease (PD) patients. A reliable and objective assessment of motor fluctuations would support the general neurologists in the referral of PD patients to the Deep Brain Stimulation (DBS) surgical centers and facilitate the DBS eligibility evaluation of PD patients usually done by the DBS specialists at the DBS surgical centers. As part of the routine clinical practice, PD patients are referred to the DBS surgical center (clinical site) to optimize their PD treatment and potentially receive a DBS therapy, and the Principal Investigator (PI), a DBS specialist, assesses their DBS eligibility following published expert evaluation criteria and assigns the patient to one of the following two groups (PI assessment): 1. DBS ready, if the patient presents severe motor fluctuations and/or clear dyskinesia history. 2. DBS not-ready, if the patient presents neither severe motor fluctuations, nor clear dyskinesia history. As part of routine clinical practice, the PKG responsible physician will provide the patient with the PKG to be worn for 6 to 10 days. Based on the Global Kinetics Corporation (GKC) algorithm applied on the data recorded by the PKG, a GKC representative assigned the patients to one of the above mentioned groups: DBS ready or DBS not-ready. The primary objective is to evaluate whether the GKC algorithm can differentiate DBS ready from DBS not-ready patients as assessed during the visit at the clinical site by the DBS specialist. The primary endpoint is therefore the percentage of agreement between the PI assessment and the GKC assessment (DBS ready or DBS not-ready) about the DBS eligibility of the PD patients.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre Hospitalier Universitaire de Grenoble
La Tronche, France
Universitätsklinikum Würzburg
Würzburg, Germany
Start Date
July 1, 2015
Primary Completion Date
February 1, 2016
Completion Date
February 1, 2016
Last Updated
January 26, 2022
38
ACTUAL participants
Parkinson's Kinetigraph
DEVICE
Lead Sponsor
MedtronicNeuro
NCT02119611
NCT07310264
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07216976