Post Market (Brio™ System) Deep Brain Stimulation (DBS) PD Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
This study is designed as a prospective, observational, non-randomized, multi-centered study for a total of 10 years in duration. It is a 10 year study from system implantation and activation with a yearly database lock and report, with the subjects being used as their own control. The primary outcome assessment will occur at three months. Following completion of the primary outcome assessment, patients will have an annual visit up to 10 years post implant. Comparison of measures within the same person from pre-treatment to post-treatment will be performed. During the implantation procedure, each subject will undergo a trial of stimulation in the operating room among other potential assessments to determine proper lead placement. The device may be internalized after a successful intra-operative trial or at a later date according to investigator site practice. The date that all components are implanted and programmed will be classified as Day 0. After system activation the subject will return to clinic for post-operative evaluations at 1 month (+/-14 days), 3 months (+/-14 days), 6 months (+/-14 days) and 12 months (+/-30 days). Thereafter, a long term data collection program will be followed for 10 years post-implant.

Official Title
-----------------
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

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
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 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: 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 is on anticoagulant medications and is unable to interrupt for time of procedure. 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 (Neurosurgeon must approve) 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
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brio DBS System<br>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 | |

What is the study measuring?
-----------------
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 | 3 months after device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDQ-8 | Quality of Life measurements through 3, 6 and 12 months as measured by the PDQ-8 compared to baseline | 3, 6 and 12 months compared to baseline | 
| modified Schwab and England | Activities of Daily Living measurement through 3, 6 and 12 months as determined from the modified Schwab and England, compared to baseline | 3, 6 and 12 months compared to baseline | 
| Levodopa dose | Comparison of Levodopa dose taken by the subject at baseline and 3, 6 and 12 month after device implantation | baseline and 3, 6 and 12 month after device implantation | 
| Satisfaction of therapy | Rate of subject and caregivers therapy satisfaction through 3, 6 and 12 months | 3, 6 and 12 months | 
| IPG Recharging information | Evaluation of the subjects/caregivers IPG Recharging information | 3 and 12 months |