Outcomes of radiofrequency ablation for movement disorders
Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System
This study looks at how well a specific treatment called radiofrequency ablation works for people with movement disorders like Parkinson's disease and essential tremor.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 4 sites (Cologne and 3 other locations) |
| Trial ID | NCT06553625 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world outcomes from patients undergoing treatment with Boston Scientific's commercially approved radiofrequency (RF) ablation systems for central nervous system applications. It focuses on conditions such as Parkinson's disease, dystonia, essential tremor, and other movement disorders. Participants will be treated with RF ablation as part of their functional neurosurgery, and their outcomes will be documented to assess the effectiveness of the intervention in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for treatment with a Boston Scientific RF system for CNS applications who can provide informed consent.
Not a fit: Patients with cognitive impairments or other characteristics that limit their ability to assess pain relief or complete study assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of RF ablation for treating movement disorders, potentially improving patient care.
How similar studies have performed: Other studies using RF ablation for movement disorders have shown promising results, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain or for CNS applications per local Directions for Use (DFU) * Signed a valid, IRB/EC/REB-approved informed consent form Exclusion Criteria: * Meets any contraindications per locally applicable Directions for Use (DFU) * Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Where this trial is running
Cologne and 3 other locations
- Uniklinik Köln — Cologne, Germany (Recruiting)
- Universitaetsklinikum Dusseldorf — Düsseldorf, Germany (Recruiting)
- Universitaetsklinikum Wuerzburg — Würzburg, Germany (Recruiting)
- St. Georges Hospital — London, United Kingdom (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.