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

Boston Scientific

Status and phase: Completed; Phase 2

Conditions: Idiopathic Parkinson's Disease

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01221948

A5001

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 53 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Deep Brain Stimulation

Experimental group

Description:

Rechargeable Deep Brain Stimulation System

Treatment:

Device: Deep Brain Stimulation