Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
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ClinicalTrials.gov Identifier: NCT02071134 |
Recruitment Status :
Recruiting
First Posted : February 25, 2014
Last Update Posted : January 10, 2023
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Tracking Information | |||||||||
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First Submitted Date | February 21, 2014 | ||||||||
First Posted Date | February 25, 2014 | ||||||||
Last Update Posted Date | January 10, 2023 | ||||||||
Actual Study Start Date | March 4, 2014 | ||||||||
Estimated Primary Completion Date | December 2028 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Improvement in patient's quality of life (QoL) during the study as compared with baseline [ Time Frame: up to 3 years ] Change in quality of life assessments during the study as compared with baseline
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title | Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry | ||||||||
Official Title | Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry | ||||||||
Brief Summary | The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease. Additionally, the utilization of Guide XT (GXT) System when used as a planning tool for the programming of patients with the Boston Scientific's Vercise DBS Systems is also evaluated. |
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Detailed Description | The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease. Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Guide XT (GXT) System when used as a planning tool for programming of patients is also evaluated. |
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Study Type | Observational [Patient Registry] | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 3 Years | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Patients with symptoms of Parkinson's disease that are not adequately controlled with medication | ||||||||
Condition | Parkinson's Disease | ||||||||
Intervention | Device: Deep Brain Stimulation (DBS)
Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their Parkinson's disease symptoms will be offered participation in this registry.
Other Names:
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Study Groups/Cohorts | Parkinson's disease
Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.
Intervention: Device: Deep Brain Stimulation (DBS)
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
1500 | ||||||||
Original Estimated Enrollment |
300 | ||||||||
Estimated Study Completion Date | December 2028 | ||||||||
Estimated Primary Completion Date | December 2028 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT. |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Poland, Spain, United Kingdom, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT02071134 | ||||||||
Other Study ID Numbers | A4010 A4069 ( Other Identifier: Boston Scientific Corporation U.S. Study ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||
Current Responsible Party | Boston Scientific Corporation | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | Boston Scientific Corporation | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Boston Scientific Corporation | ||||||||
Verification Date | January 2023 |