Optimized Programming in Spinal Cord Stimulation (SCS) System

Phase 4

Completed

Conditions: Neuropathic Pain
Pain

Interventions: Device: Precision Spinal Cord Stimulation (SCS)

Registration Number: NCT00871819

Lead Sponsor: Boston Scientific Corporation

Brief Summary: The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.

Detailed Description: The clinical results from this study may help to validate predictions made by mathematical models of neurons that are activated by SCS and increase scientific knowledge about the way in which different programs relate to satisfactory outcomes, such that use of the model may help in the development of new products.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Be previously implanted with Precision SCS System (3-36 months post permanent implant) having 2 parallel percutaneous leads placed between T8-T10.
Be implanted with Precision SCS System for the treatment of neuropathic pain of trunk and/or limbs
Be 18 years of age or older
Be extremely satisfied, very satisfied, or satisfied with SCS therapy for treatment of pain condition
Be able to use pen tablet to document regions of paresthesia and pain
Be able to lie in the supine position for 45 minutes at a minimum
Be able to verbally report qualitative and quantitative aspects of paresthesia sensations.
Have a paresthesia threshold on a standard program below 4mA while in the supine position
Have at minimum the upper contact of one lead below T8 and the lower contact above T11 vertebral levels
Be willing and able to comply with study-related procedure
Agree to study requirements and provides written Informed Consent

Exclusion Criteria

Unable to read, write, speak, and understand English
Currently pregnant or planning to become pregnant during the course of the study
Have negative finding in any of the pre-screening and screening requirements
Upon fluoroscopy, location of both leads is identified to be outside T8-T10 vertebral levels
Unable to perceive the sensation of paresthesia associated with stimulation in the trunk and/or lower extremities
Have a drug pump and/or a non-Precision neurostimulation device (regardless of whether active or inactive)
Have had any interventional pain procedure or surgeries (including Interlaminar epidural steroid injection, Transforaminal epidural steroid injection, Caudal epidural steroid injection, Selective nerve root block, Intraarticular lumbar facet injection, Sacroiliac joint injection, Piriformis muscle injection, Trochanteric bursa injection, Hip/knee joint injections, Medial branch block (innervates facet joint), Pulsed radiofrequency neurotomy medial branches, Pulsed radiofrequency dorsal root ganglion, Thermal (high temperature) radiofrequency neurotomy medial branches, Trigger point injections, and Botulinum toxin injections) involving the spine within the past 30 days
Have any condition that is likely to confound evaluation of study endpoints. Conditions that may make paresthesia coverage variable over the course of the study include multiple sclerosis, partial spinal cord injury, diabetic peripheral neuropathy, peripheral vascular disease, scoliosis, deafferentation, etc.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation Group	Precision Spinal Cord Stimulation (SCS)	Spinal Cord Stimulation (SCS) Treatment Group

Primary Outcome Measures

Name	Time	Method
Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)	Immediately post-procedure

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): University of California, San Diego Medical Center
🇺🇸
San Diego, California, United States
University of California, San Diego Medical Center
🇺🇸San Diego, California, United States