Dystonia, Essential Tremor, Movement Disorders, Parkinson Disease
Conditions
Brief summary
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
Detailed description
The objective of this study is to compile real-world outcomes of Boston Scientific Corporation commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
Interventions
DEVICERadiofrequency Ablation
Radiofrequency Ablation used in the central nervous system (CNS) in functional neurosurgery
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient's quality of life (QoL) during the study as compared with baseline | Up to 24-Months | Change in quality of life assessments during the study as compared with baseline |
Countries
Germany, United Kingdom
Contacts
CONTACTStephanie Delvaux
CONTACTDiane Keesey
STUDY_DIRECTORNatalie M Bloom Lyons, M.A.
Boston Scientific Corporation
Outcome results
None listed