Vercise Implantable Stimulator for Treating Parkinson's Disease (VANTAGE)

• Number of participants with adverse events (AEs), including serious adverse events (SAEs), as a measure of Safety [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: Yes ]
• Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the mentation, behavior, and mood scores of the UPDRS [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in antiparkinsonian medication use [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in hand-arm movement test score [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in tremor rating scale [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the dyskinesia rating scale score [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the number of waking hours per day with good symptom control and no troublesome dyskinesia [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in quality of life scale scores [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  Short Form Health Survey (SF-36), Parkinson's Disease Questionnaire (PDQ-39) and modified Schwab and England (SE)
• Change in the Global Impression of Change Scale (GIC) rating score [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Changes in resource utilization [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in freezing of gait episodes [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the mentation, behavior, and mood scores of the UPDRS [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the mentation, behavior, and mood scores of the UPDRS [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the activities of daily living score of the UPDRS [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the activities of daily living score of the UPDRS [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the activities of daily living score of the UPDRS [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the therapy complication score of the UPDRS [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the therapy complication score of the UPDRS [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the therapy complication score of the UPDRS [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the overall score of the UPDRS [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the overall score of the UPDRS [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the overall score of the UPDRS [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in antiparkinsonian medication use [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in antiparkinsonian medication use [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in hand-arm movement test score [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in hand-arm movement test score [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in walking test score [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in walking test score [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in walking test score [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in tremor rating scale [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in tremor rating scale [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the dyskinesia rating scale score [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the dyskinesia rating scale score [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the number of waking hours per day with good symptom control and no troublesome dyskinesia [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the number of waking hours per day with good symptom control and no troublesome dyskinesia [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in quality of life scale scores [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  Short Form Health Survey (SF-36), Parkinson's Disease Questionnaire (PDQ-39) and modified Schwab and England (SE)
• Change in quality of life scale scores [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  Short Form Health Survey (SF-36), Parkinson's Disease Questionnaire (PDQ-39) and modified Schwab and England (SE)
• Change in the Global Impression of Change Scale (GIC) rating score [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in the Global Impression of Change Scale (GIC) rating score [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Changes in resource utilization [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Changes in resource utilization [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in freezing of gait episodes [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
• Change in freezing of gait episodes [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]

The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).

Key Inclusion Criteria:

1. Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia.
2. Duration of bilateral idiopathic PD of more than five years.
3. Stable medications
4. UPDRS subset III score of ≥30 without medication.
5. Lack of dementia or depression.
6. Must improve with antiparkinsonian medication, but have some motor complications that are not well controlled by medications.
7. Must be an appropriate candidate for the surgical procedures required for bilateral STN DBS.
8. Is willing and able to comply with all visits and study related procedures
9. Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

1. Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
2. Any finding in neuropsychological screening assessments that would contraindicate DBS surgery, including dementia.
3. Any significant psychiatric problems, including unrelated clinically significant depression.
4. Any current drug or alcohol abuse.
5. Any history of recurrent or unprovoked seizures.
6. Frequent falls while receiving good medication therapy without dyskinesias (on-state).
7. Any prior movement disorder treatments that involved intracranial surgery or device implantation.
8. Any other active implanted device.
9. Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
10. A history of neurostimulation intolerance in any area of the body.
11. A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
12. Currently on any anticoagulant medications that can not be discontinued during perioperative period.
13. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
14. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
15. A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or not using adequate contraception.