Registry of Deep Brain Stimulation for Essential Tremor
Boston Scientific Registry of Deep Brain Stimulations for Treatment of Essential Tremor (ET):ET Registry
This study is collecting information from people with Essential Tremor who are using a specific brain stimulation device to see how well it works in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 20 sites (Innsbruck and 19 other locations) |
| Trial ID | NCT04032470 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compile real-world outcomes of Boston Scientific's Deep Brain Stimulation (DBS) systems used for treating Essential Tremor. By collecting data on patient characteristics and treatment results, the study seeks to enhance the existing evidence base for DBS in this condition. Participants will be monitored according to the Directions for Use established by the manufacturer, ensuring adherence to safety and efficacy protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who meet the criteria for DBS treatment as outlined in the Directions for Use.
Not a fit: Patients who have contraindications as specified in the Directions for Use will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of DBS for patients with Essential Tremor, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies have shown positive outcomes with Deep Brain Stimulation for Essential Tremor, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meets criteria established in the locally applicable Directions for Use (DFU) for Essential Tremor * Is at least 18 years old Exclusion Criteria: * Meets any contraindication in locally applicable Directions for Use
Where this trial is running
Innsbruck and 19 other locations
- A.o. LKH Univ.-Kliniken Innsbruck — Innsbruck, Austria (Recruiting)
- AZ Sint-Lucas — Ghent, Belgium (Recruiting)
- UZ Gasthuisberg — Leuven, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- Vancouver General Hospital — Vancouver, Canada (Recruiting)
- Uniklinik Koln — Cologne, Germany (Recruiting)
- Universitaetsklinikum Dusseldorf — Düsseldorf, Germany (Recruiting)
- Universitaetsklinikum Essen — Essen, Germany (Recruiting)
- Universitatsklinikum Campus Kiel — Kiel, Germany (Recruiting)
- Universitaetsklinikum Giessen und Marburg GmbH — Marburg, Germany (Recruiting)
- Evangelisches Krankenhaus Oldenburg — Oldenburg, Germany (Recruiting)
- Universitaetsklinikum Wuerzburg — Würzburg, Germany (Recruiting)
- Medical School of University PECS — Pécs, Hungary (Recruiting)
- Policlinico Universitario Agostino Gemelli — Rome, Italy (Withdrawn)
- CHU Sao Joao — Porto, Portugal (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul ASAN Medical Center — Seoul, South Korea (Withdrawn)
- Yonsei University Severance Hospital — Seoul, South Korea (Recruiting)
- Hospital De Bellvitge — Barcelona, Spain (Recruiting)
- Hospital General De Asturias — Oviedo, Spain (Recruiting)
Study contacts
- Study coordinator: Stephanie Delvaux
- 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.