Post Market (Brio™ System) Deep Brain Stimulation (DBS) PD Study
Post Market (Brio™ System) Deep Brain Stimulation (DBS) PD Study
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.
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.
Inclusion Criteria:

 1. Subject has signed an informed consent.

 2. Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.

 3. Subject is a candidate for surgery.

 4. Subject is 18 to 80 years of age.

 5. 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.

 6. Subject should be stable on anti-Parkinson's disease medication for at least one month
 prior to study enrollment

 Exclusion Criteria:

 1. Subject has any major illness or medical condition that in the opinion of the
 physician would interfere with participation in the study.

 2. Subject has non-treated clinically significant depression or any other significant
 psychiatric co-morbidities.

 3. Subject has any condition requiring repeated MRI scans;

 4. Subject is on anticoagulant medications and is unable to interrupt for time of
 procedure.

 5. 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.

 6. Subject abuses drugs or alcohol.

 7. Subject has a history of seizure (Neurosurgeon must approve)

 8. Subject has confirmation of diagnosis of a terminal illness associated with survival
 <12 months.

 9. Female that is lactating or of childbearing potential with positive urine pregnancy
 test or not using adequate birth control.

 10. Subject has participated in a drug, device or biological trial within the preceding 30
 days.