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

Implantable Neurostimulator for the Treatment of Parkinson's Disease

The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.

GUIDE XT may be used for planning of programming as needed.

Key Inclusion Criteria:

• Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
• Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
• Able to understand 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.
• Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
• Any other active implanted devices including neurostimulators and /or drug delivery pumps
• Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
• Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
• A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.