Status:
COMPLETED
Vercise Implantable Stimulator for Treating Parkinson's Disease
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Idiopathic Parkinson's Disease
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system...
Detailed Description
This is a multi-center, prospective, open label, non-randomized study which will use a within-patient control (each patient serves as his/her own control) to document patient outcomes, including effec...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia.
- Duration of bilateral idiopathic PD of more than five years.
- Stable medications
- UPDRS subset III score of ≥30 without medication.
- Lack of dementia or depression.
- Must improve with antiparkinsonian medication, but have some motor complications that are not well controlled by medications.
- Must be an appropriate candidate for the surgical procedures required for bilateral STN DBS.
- Is willing and able to comply with all visits and study related procedures
- Patient understands 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.
- Any finding in neuropsychological screening assessments that would contraindicate DBS surgery, including dementia.
- Any significant psychiatric problems, including unrelated clinically significant depression.
- Any current drug or alcohol abuse.
- Any history of recurrent or unprovoked seizures.
- Frequent falls while receiving good medication therapy without dyskinesias (on-state).
- Any prior movement disorder treatments that involved intracranial surgery or device implantation.
- Any other active implanted device.
- Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
- A history of neurostimulation intolerance in any area of the body.
- A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
- Currently on any anticoagulant medications that can not be discontinued during perioperative period.
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months.
- Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
- A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or not using adequate contraception.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01221948
Start Date
October 1 2010
End Date
June 1 2018
Last Update
February 5 2025
Active Locations (7)
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1
Allgemeines Krankenhaus AKH
Vienna, Austria
2
CHU de Rennes-Pontchaillou
Rennes, France
3
Uniklinik Köln
Cologne, Germany
4
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy