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KITE
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.
Sponsor study identifier
observational
38
2 countries
2
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)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):
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
July 24, 2015
Actual (reported)July 28, 2015
Actual (reported)February 2016
Actual (reported)February 2016
Actual (reported)Percentage of agreement between the PI assessment and the GKC assessment to differentiate the DBS Ready (DS) from the DBS Not-Ready (DNR) group.
The percentage of agreement is the number of patients in the Per Protocol (PP) set for which the GKC assessment is equal to the PI assessment, divided by the total number of patients in the Per Protocol (PP) set and multiplied by 100.
The PI assessment is performed during the examination of the patient by the DBS specialist on the first day of the study. The GKC assessment is calculated once the PKG is returned and it is based on the time period of 6 days of PKG recordings
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population is represented by Parkinson's Disease (PD) patients who are referred to the DBS surgical center (clinical site) as potential surgical candidate for DBS or to optimize their PD treatment.
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700, France
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.
38 participants (actual enrollment reported by the registry).
First Submitted
July 24, 2015
First Posted
July 28, 2015
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
January 26, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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