CoverEdge Algorithm Programming Study
Not Applicable
Completed
- Conditions
- Chronic Pain
- Registration Number
- NCT02492880
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Subject implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU).
- Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
- Subject is 18 years of age or older when written informed consent is obtained.
Exclusion Criteria
- Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU.
- Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire minimum 25 days post IPG implant Change in paresthesia distribution based on programming parameters
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Barolat Neuroscience
🇺🇸Denver, Colorado, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Barolat Neuroscience🇺🇸Denver, Colorado, United States