Trial record 18 of 128 for:    Deep Brain Stimulation for Parkinson's Disease

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02071134
First received: February 21, 2014
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Parkinson's Disease
Device: Deep Brain Stimulation (DBS)

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Improvement in patient's quality of life (QoL) during the study as compared with baseline [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Change in quality of life assessments during the study as compared with baseline


Other Outcome Measures:
  • Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Change in patient's motor symptoms as determined by UPDRS during the study as compared with baseline

  • Change in medication usage during the study as compared with baseline [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Impression of change scores during the study as compared with baseline [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Impression of change scores during the study as compared with baseline


Estimated Enrollment: 300
Study Start Date: February 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Inclusion Criteria:

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

Exclusion Criteria:

  • Meets any contraindication in the Vercise System locally applicable Directions for Use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071134

Contacts
Contact: Nic Van Dyck 31-43-356-8328 VanDycKN@bsci.com

Locations
France
Boston Scientific International SA Recruiting
Paris, France
Contact: Boston Scientific Clinical Research       BSNClinicaltrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Roshini Jain Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02071134     History of Changes
Other Study ID Numbers: A4010
Study First Received: February 21, 2014
Last Updated: February 24, 2014
Health Authority: Italy: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Boston Scientific Corporation:
Deep brain stimulation
Parkinson's disease
Vercise

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 20, 2014