Evaluating outcomes of Deep Brain Stimulation for movement disorders
Deep Brain Stimulation (DBS) Retrospective Outcomes Study
This study looks at how well Deep Brain Stimulation works for people with Parkinson's Disease, Essential Tremor, and Dystonia by reviewing past patient records.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 19 sites (Phoenix, Arizona and 18 other locations) |
| Trial ID | NCT03664609 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the real-world clinical outcomes of Deep Brain Stimulation (DBS) in patients with Parkinson's Disease, Essential Tremor, and Dystonia through a retrospective review of de-identified patient records. By examining previously treated patients, the study seeks to gather insights into the effectiveness and safety of DBS in managing these conditions. The methodology involves collecting and analyzing data from multiple medical centers to ensure a comprehensive understanding of patient experiences and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have been previously treated with or are eligible for implantation of a Deep Brain Stimulation system.
Not a fit: Patients who have not undergone Deep Brain Stimulation or are not candidates for the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Deep Brain Stimulation, potentially leading to improved treatment strategies for patients with movement disorders.
How similar studies have performed: Other studies have shown promising outcomes with Deep Brain Stimulation for similar conditions, indicating that this approach has been previously validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be previously treated with or eligible for implantation with a deep brain stimulation system Exclusion Criteria: * No Exclusion Criteria
Where this trial is running
Phoenix, Arizona and 18 other locations
- St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- University of Miami Hospital — Miami, Florida, United States (Recruiting)
- University of South Florida — Tampa, Florida, United States (Recruiting)
- St. Luke's Regional Medical Center — Boise, Idaho, United States (Recruiting)
- Albany Medical Center — Albany, New York, United States (Recruiting)
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States (Recruiting)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Swedish Neuroscience Institute — Seattle, Washington, United States (Completed)
- AZ St. Lucas — Ghent, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- Hopital Fondation Adolphe de Rothschild — Paris, France (Recruiting)
- Uniklinik Köln — Cologne, Germany (Recruiting)
- Universitaetsklinikum Dusseldorf — Düsseldorf, Germany (Recruiting)
- Uniklinikum Jena — Jena, Germany (Completed)
- Universitaetsklinikum Schleswig-Holstein — Lübeck, Germany (Recruiting)
- Universitaetsklinikum Wuerzburg — Würzburg, Germany (Recruiting)
- Fondazione Istituto Neurologico Casimiro Mondino — Pavia, Italy (Recruiting)
- Hospital Virgen Del Rocio — Seville, Spain (Recruiting)
Study contacts
- Study coordinator: Cleo Mertz
- Email: BSNClinicalTrials@bsci.com
- Phone: 855-213-9890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.