A Post Market Clinical Evaluation of Deep Brain Stimulation as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication
Sponsor study identifier
observational
21
3 countries
6
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Study Completion
December 2013
Actual (reported)The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation system using constant current instead of constant voltage and using a lead with an active electrode tip.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 14, 2011
Actual (reported)May 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 12, 2011
Actual (reported)March 2013
Actual (reported)December 2013
Actual (reported)UPDRS motor scores
Comparison of Parkinson's symptoms as demonstrated by the UPDRS motor scores in the medication 'Off' state at Baseline compared to the medication 'Off' with stimulation "On" 3 months after device implantation
[Time Frame: 3 months after device implantation].
Satisfaction of therapy
[through 3, 6 months and 1 year]
Economic burden of the disease
[at baseline and 1 year]
Rating on caregiver's burden determined from Zarit Caregivers Burden Interview (ZCBI)
[at baseline, 3 month and 1 year]
Assessment of the way of coping as determined from the Way of Coping Checklist (WCC) from caregiver
[baseline, 3,6 month and 1 year]
Libra™/LibraXP™ DBS System Eligible subjects in this study will be screened to confirm that they meet the strict guidelines for advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication followed by surgery to implant the Libra™/LibraXP™ deep brain simulation system.
Hopital Neurologique
Lyon, 69003, France
CHU Laennec
Nantes, 44799, France
University Hospital Bonn
Bonn, Germany
University Hospital of Duesseldorf
Düsseldorf, Germany
University Hospital Regensburg
Regensburg, 93053, Germany
Erciyes University Medicine School
Kayseri, Turkey (Türkiye)
Jan Vesper, Prof
Universitätsklinukum Dusseldorf
21 participants (actual enrollment reported by the registry).
First Submitted
April 14, 2011
First Posted
May 12, 2011
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease
Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation
Contact the study team to confirm eligibility.
Primary Completion
March 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
November 9, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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