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NCT03664609 Clinical Trial

Deep Brain Stimulation (DBS) Retrospective Outcomes Study

Parkinson Disease Clinical Trial

Official title:
Deep Brain Stimulation (DBS) Retrospective Outcomes Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03664609
Other study ID # A4170
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 12, 2019
Est. completion date December 2028

Study information
Verified date April 2024
Source Boston Scientific Corporation
Contact Cleo Mertz
Phone 855-213-9890
Email BSNClinicalTrials@bsci.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Must be previously treated with or eligible for implantation with a deep brain stimulation system Exclusion Criteria: - No Exclusion Criteria

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium AZ St. Lucas Gent
Belgium AZ Delta Roeselare
Germany Uniklinikum Jena Jena
Germany Uniklinik Köln Köln
Germany Universitaetsklinikum Schleswig-Holstein Lübeck
Germany Universitaetsklinikum Wuerzburg Würzburg
United States Albany Medical Center Albany New York
United States St. Luke's Regional Medical Center Boise Idaho
United States University of Miami Hospital Miami Florida
United States St. Joseph's Hospital & Medical Center Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States The Regents of the University of California, San Francisco campus San Francisco California
United States Swedish Neuroscience Institute Seattle Washington
United States University of South Florida Tampa Florida
United States Wake Forest University School of Medicine Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline 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 5 yrs. post implant
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