Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects enrolled in this study must meet the following inclusion criteria: Subject has signed an informed consent. Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease. Subject is a candidate for surgery. Subject is 18 to 80 years of age. Subject has a history of improvement of Parkinson's symptoms as a direct result of administering l-dopa to the subject with at least a 25% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score or subject has been diagnosed with tremor-dominant Parkinson's disease. Subject should be stable on anti-Parkinson's disease medication for at least one month prior to study enrollment. Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following criteria: Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study. Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities. Subject has any condition requiring repeated MRI scans; Subject has any condition requiring diathermy; Subject is on anticoagulant medications and is unable to interrupt for time of procedure. Subject has a history of cranial surgery. Subject has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the Informed Consent as determined by the investigator. Subject abuses drugs or alcohol. Subject has a history of seizure Subject has confirmation of diagnosis of a terminal illness associated with survival <12 months. Female that is lactating or of childbearing potential with positive urine pregnancy test or not using adequate birth control. Subject has participated in a drug, device or biological trial within the preceding 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of therapy | Rate of subject and caregivers therapy satisfaction through 3, 6 month and 1 year | [through 3, 6 months and 1 year] | 
| Economic burden of the disease | Rate on economic burden of the disease for caregiver determined from economic burden questionnaire at baseline and 1 year | [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] |