Deep Brain Stimulation (DBS) Retrospective Outcomes Study

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03664609
Collaborator
(none)
5,000
15
111.6
333.3
3

Study Details

Study Description

Brief Summary

The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Condition or Disease Intervention/Treatment Phase
  • Device: Deep Brain Stimulation

Detailed Description

The purpose of this study is to characterize

  1. real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Deep Brain Stimulation (DBS) Retrospective Outcomes Study
Actual Study Start Date :
Mar 12, 2019
Anticipated Primary Completion Date :
Jun 29, 2028
Anticipated Study Completion Date :
Jun 29, 2028

Arms and Interventions

Arm Intervention/Treatment
Parkinson's Disease

Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System

Device: Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.

Essential Tremor

Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System

Device: Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.

Dystonia

Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System

Device: Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.

Outcome Measures

Primary Outcome Measures

  1. Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline [5 yrs. post implant]

    Improvement in disease symptoms as assessed by Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Must be previously treated with or eligible for implantation with a deep brain stimulation system
Exclusion Criteria:
  • No Exclusion Criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Joseph's Hospital & Medical Center Phoenix Arizona United States 85013
2 The Regents of the University of California, San Francisco campus San Francisco California United States 94143
3 University of Miami Hospital Miami Florida United States 33136
4 University of South Florida Tampa Florida United States 33612
5 St. Luke's Regional Medical Center Boise Idaho United States 83712
6 Albany Medical Center Albany New York United States 12208
7 Wake Forest University School of Medicine Winston-Salem North Carolina United States 27157
8 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
9 Swedish Neuroscience Institute Seattle Washington United States 98122
10 AZ St. Lucas Gent Belgium
11 AZ Delta Roeselare Belgium
12 Uniklinikum Jena Jena Germany
13 Uniklinik Köln Köln Germany
14 Universitaetsklinikum Schleswig-Holstein Lübeck Germany
15 Universitaetsklinikum Wuerzburg Würzburg Germany

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

  • Study Director: Roshini Jain, Boston Scientific Neuromodulation Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT03664609
Other Study ID Numbers:
  • A4170
First Posted:
Sep 10, 2018
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022