Status:
COMPLETED
Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Parkinson's Disease
Eligibility:
All Genders
22-75 years
Phase:
NA
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-respo...
Detailed Description
The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. GUIDE XT may be used for planning of programming as needed.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2022
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT01839396
Start Date
May 17 2013
End Date
December 5 2022
Last Update
July 13 2023
Active Locations (22)
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1
Muhammad Ali Parkinson Research Center and Movement Disorders Clinic
Phoenix, Arizona, United States, 85013
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Kaiser Permanente, Sacramento
Sacramento, California, United States, 95825
4
University of California, San Francisco
San Francisco, California, United States, 94115