Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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.