Implantable Neurostimulator for the Treatment of Parkinson’s Disease
Sponsor:
Brief Summary:
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.
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.
Locations
- , Los Angeles, California, United States, 90048
- Boston Scientific Clinical Research Information Toll Free Number, Valencia, California, United States, 91355
