Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study
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 will be the first study in Parkinson's 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- UPDRS motor scores [ Time Frame: [Time Frame: 3 months after device implantation]. ] [ Designated as safety issue: No ]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] ] [ Designated as safety issue: No ]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] ] [ Designated as safety issue: No ]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] ] [ Designated as safety issue: No ]
- 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] ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.