Recruiting NCT03664609
Deep Brain Stimulation (DBS) Retrospective Outcomes Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep Brain Stimulation.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Essential Tremor, Dystonia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, France, Germany, Italy +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- Device Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.
Primary outcome measures
- Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline [Time frame: 5 yrs. post implant]
Eligibility criteria
Inclusion criteria
- Must be previously treated with or eligible for implantation with a deep brain stimulation system
Exclusion criteria
- No Exclusion Criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 9 centers
- St. Joseph's Hospital & Medical Center — Phoenix
- University of California, San Francisco — San Francisco
- University of Miami Hospital — Miami
- University of South Florida — Tampa
- St. Luke's Regional Medical Center — Boise
- Albany Medical Center — Albany
- Wake Forest University School of Medicine — Winston-Salem
- Allegheny General Hospital — Pittsburgh
- … and 1 more center
Germany · 5 centers
- Uniklinik Köln — Cologne
- Universitaetsklinikum Dusseldorf — Düsseldorf
- Uniklinikum Jena — Jena
- Universitaetsklinikum Schleswig-Holstein — Lübeck
- Universitaetsklinikum Wuerzburg — Würzburg
Belgium · 2 centers
- AZ St. Lucas — Ghent
- AZ Delta — Roeselare
France · 1 center
- Hopital Fondation Adolphe de Rothschild — Paris
Italy · 1 center
- Fondazione Istituto Neurologico Casimiro Mondino — Pavia
Spain · 1 center
- Hospital Virgen Del Rocio — Seville
Identifiers
NCT: NCT03664609 · A4170