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Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02071134
Recruitment Status : Recruiting
First Posted : February 25, 2014
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.


Condition or disease Intervention/treatment
Parkinson's Disease Device: Deep Brain Stimulation (DBS)

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]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
Actual Study Start Date : February 2014
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson's disease
Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.
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:
  • Vercise DBS System
  • Boston Scientific




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline [ Time Frame: up to 3 years ]
    Change in patient's motor symptoms as determined by UPDRS during the study as compared with baseline

  2. Change in medication usage during the study as compared with baseline [ Time Frame: up to 3 years ]
  3. Impression of change scores during the study as compared with baseline [ Time Frame: 3 years ]
    Impression of change scores during the study as compared with baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptoms of Parkinson's disease that are not adequately controlled with medication
Criteria

Key Inclusion Criteria:

  • Meets criteria established in locally applicable Vercise System Direction for Use
  • At least 18 years old

Key Exclusion Criteria:

  • Meets any contraindication in the Vercise System locally applicable Directions for Use

Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071134


Contacts
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Contact: Diane Bowers Diane.bowers@bsci.com
Contact: Roshini Jain 469-766-9888 Roshini.Jain@bsci.com

Locations
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United States, California
Boston Scientific Clinical Research Toll-Free Number Recruiting
Valencia, California, United States, 91355
Contact    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain Boston Scientific Neuromodulation Corporation
Additional Information:

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02071134    
Other Study ID Numbers: A4010
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Boston Scientific Corporation:
Deep brain stimulation
Parkinson's disease
Vercise
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases