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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):
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parkinson's Kinetigraph | Device |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Grenoble | La Tronche | 38700 | France | |||
| Universitätsklinikum Würzburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25928634 | Background | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Würzburg |
| 97080 |
| Germany |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |