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History of Changes for Study: NCT02071134
Registry of Deep Brain Stimulation With the VERCISEā„¢ System: Vercise DBS Registry
Latest version (submitted December 6, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 24, 2014 None (earliest Version on record)
2 December 3, 2015 Study Status
3 February 4, 2016 Study Status and Study Design
4 November 15, 2016 Study Status
5 February 6, 2018 Study Status
6 October 9, 2018 Study Status
7 November 29, 2018 Contacts/Locations and Study Status
8 December 21, 2018 Contacts/Locations, Oversight and Study Status
9 January 15, 2019 Study Status
10 September 10, 2019 Study Description, Study Status and Eligibility
11 October 2, 2019 Study Status
12 April 7, 2020 Study Status
13 November 17, 2020 Contacts/Locations and Study Status
14 December 11, 2020 Study Status and Study Identification
15 January 11, 2021 Study Status and Contacts/Locations
16 February 4, 2021 Contacts/Locations and Study Status
17 March 17, 2021 Contacts/Locations and Study Status
18 March 31, 2021 Study Status
19 May 5, 2021 Contacts/Locations and Study Status
20 June 9, 2021 Contacts/Locations and Study Status
21 July 1, 2021 Contacts/Locations and Study Status
22 July 2, 2021 Contacts/Locations and Study Status
23 September 22, 2021 Contacts/Locations and Study Status
24 October 11, 2021 Contacts/Locations and Study Status
25 October 13, 2021 Study Design and Study Status
26 December 1, 2021 Study Status and Contacts/Locations
27 January 25, 2022 Contacts/Locations and Study Status
28 February 4, 2022 Contacts/Locations and Study Status
29 March 9, 2022 Study Status
30 April 13, 2022 Study Status and Contacts/Locations
31 May 6, 2022 Study Status and Contacts/Locations
32 June 14, 2022 Contacts/Locations and Study Status
33 July 12, 2022 Study Status and Contacts/Locations
34 August 9, 2022 Contacts/Locations and Study Status
35 September 6, 2022 Study Status and Contacts/Locations
36 October 6, 2022 Contacts/Locations and Study Status
37 November 3, 2022 Study Status
38 November 7, 2022 Contacts/Locations and Study Status
39 December 6, 2022 Study Status
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Study NCT02071134
Submitted Date:  February 24, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: A4010
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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2014
Overall Status: Recruiting
Study Start: February 2014
Primary Completion: December 2016 [Anticipated]
Study Completion: December 2018 [Anticipated]
First Submitted: February 21, 2014
First Submitted that
Met QC Criteria:
February 24, 2014
First Posted: February 25, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 24, 2014
Last Update Posted: February 25, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Boston Scientific Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
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.

Open or close this module Conditions
Conditions: Parkinson's Disease
Keywords: Deep brain stimulation
Parkinson's disease
Vercise
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 300 [Anticipated]
Number of Groups/Cohorts 1
Target Follow-Up Duration: 3 Years
Open or close this module Groups and Interventions
Groups/Cohorts 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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Study Population: Patients with symptoms of Parkinson's disease that are not adequately controlled with medication
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Nic Van Dyck
Telephone: 31-43-356-8328
Email: VanDycKN@bsci.com
Study Officials: Roshini Jain
Study Director
Boston Scientific Corporation
Locations: France
Boston Scientific International SA
[Recruiting]
Paris, France
Contact:Contact: Boston Scientific Clinical Research BSNClinicaltrials@bsci.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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