Optimized Programming in Spinal Cord Stimulation (SCS) System
Condition: Neuropathic Pain; Pain
MeSH terms: Neuralgia
Intervention: Precision Spinal Cord Stimulation (SCS)
Intervention description: Various SCS device programming parameters
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Spinal Cord Stimulation

Summary:

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

Eligibility criteria:

        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.