NCT02509325

Parkinson's KinetiGraph as Tool for DBS Eligibility Assessment

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	Parkinson's Kinetigraph

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-07-28
• Last updated: 2022-01-26

Locations

2 sites across 2 countries: France, Germany