Business reasons
A CLINICAL EVALUATION OF A RECHARGEABLE DEEP BRAIN STIMULATION SYSTEM 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
0
0 countries
N/A
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)The objective of this study is to evaluate the effectiveness of a rechargeable 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. This is the first observational study for the use of the BRIO™ rechargeable constant current device, using a lead with an active electrode tip for deep brain stimulation in Parkinson subjects. The current study was designed to conform to normal medical practices, taking into consideration the current day economic constraints, while assessing the best set of circumstances for the successful sustained reduction of some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.
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.
October 8, 2010
Actual (reported)October 11, 2010
Actual (reported)October 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 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
3 months after device implantation
PDQ-8
3, 6 and 12 months compared to baseline
modified Schwab and England
3, 6 and 12 months compared to baseline
Levodopa dose
baseline and 3, 6 and 12 month after device implantation
Satisfaction of therapy
3, 6 and 12 months
IPG Recharging information
3 and 12 months
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 bilateral surgery to implant the Brio™ deep brain stimulation system
Patients with advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication 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
0 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2010
First Posted
October 11, 2010
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Feasibility of Continuous Sleep Recording in Patients Undergoing Deep Brain Stimulation for Parkinson's Disease
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
February 4, 2019
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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