Vercise Implantable Stimulator for Treating Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Deep Brain Stimulation
Intervention description: Rechargeable Deep Brain Stimulation System
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Deep Brain Stimulation; Parkinson's Disease

Summary:

      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).
    

Eligibility criteria:

        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.