Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01352819|
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : August 10, 2015
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.
|Condition or disease|
This study is designed as a prospective, observational, non-randomized, multi-centered study for 12 months in duration from implantation with the subjects being used as their own control. The primary outcome assessment will occur at three months: however, subjects will be followed for one year.
A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||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|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||December 2013|
- UPDRS motor scores [ Time Frame: [Time Frame: 3 months after device implantation]. ]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
- Satisfaction of therapy [ Time Frame: [through 3, 6 months and 1 year] ]Rate of subject and caregivers therapy satisfaction through 3, 6 month and 1 year
- Economic burden of the disease [ Time Frame: [at baseline and 1 year] ]Rate on economic burden of the disease for caregiver determined from economic burden questionnaire at baseline and 1 year
- Rating on caregiver's burden determined from Zarit Caregivers Burden Interview (ZCBI) [ Time Frame: [at baseline, 3 month and 1 year] ]
- Assessment of the way of coping as determined from the Way of Coping Checklist (WCC) from caregiver [ Time Frame: [baseline, 3,6 month and 1 year] ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352819
|Lyon, France, 69003|
|Nantes, France, 44799|
|University Hospital Bonn|
|University Hospital of Duesseldorf|
|University Hospital Regensburg|
|Regensburg, Germany, 93053|
|Erciyes University Medicine School|
|Principal Investigator:||Jan Vesper, Prof||Universitätsklinukum Dusseldorf|