CoverEdge Algorithm Programming Study

Boston Scientific Corporation15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

Precision Spectra™ SCS system programming featuresDEVICE

Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Barolat Neuroscience

Denver, Colorado, United States

Albany Medical Center

Albany, New York, United States

Outcomes

Primary Outcomes

Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire

Change in paresthesia distribution based on programming parameters

Time frame: minimum 25 days post IPG implant

Data from ClinicalTrials.gov

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