Vercise Implantable Stimulator for Treating Parkinson's Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2018-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

NCT01839396

Parkinson's Disease

COMPLETED NA

CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

NCT01896115

Parkinson's Disease

COMPLETED NA

Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

NCT02071134

Parkinson's Disease

RECRUITING

Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation

NCT02835274

Parkinson Disease

COMPLETED NA

One Pass thalamIc aNd subthalamIc stimulatiON

NCT02288468

Parkinson's Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Deep Brain Stimulation

Rechargeable Deep Brain Stimulation System

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Rechargeable Deep Brain Stimulation System

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Deep Brain Stimulation

Rechargeable Deep Brain Stimulation System

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No