Vercise Implantable Stimulator for Treating Parkinson's Disease

This is a multi-center, prospective, open label, non-randomized study which will use a within-patient control (each patient serves as his/her own control) 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:

• Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia.
• Duration of bilateral idiopathic PD of more than five years.
• Stable medications
• UPDRS subset III score of ≥30 without medication.
• Lack of dementia or depression.
• Must improve with antiparkinsonian medication, but have some motor complications that are not well controlled by medications.
• Must be an appropriate candidate for the surgical procedures required for bilateral STN DBS.
• Is willing and able to comply with all visits and study related procedures
• 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:

• Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
• Any finding in neuropsychological screening assessments that would contraindicate DBS surgery, including dementia.
• Any significant psychiatric problems, including unrelated clinically significant depression.
• Any current drug or alcohol abuse.
• Any history of recurrent or unprovoked seizures.
• Frequent falls while receiving good medication therapy without dyskinesias (on-state).
• Any prior movement disorder treatments that involved intracranial surgery or device implantation.
• Any other active implanted device.
• Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
• A history of neurostimulation intolerance in any area of the body.
• A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
• Currently on any anticoagulant medications that can not be discontinued during perioperative period.
• 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.
• 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.
• A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or not using adequate contraception.