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Implantable Neurostimulator for the Treatment of Parkinson’s Disease


Brief Summary:

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.


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

– 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

– 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

– 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.


  • , Los Angeles, California, United States, 90048
  • Boston Scientific Clinical Research Information Toll Free Number, Valencia, California, United States, 91355
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