Stimgenics Open-Label, Post Market Study

Study Overview
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Brief Summary
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The purpose of this investigational study is to study the effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low back pain and leg pain.

Detailed Description
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This is an open-label prospective, randomized, controlled, multi-center study comparing Stimgenics Spinal Cord Stimulation (SGX-SCS) programming approach to Standard SCS programming approach. Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: Test treatment group with SGX-SCS programming approach Control treatment group with Standard SCS programming approach Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.

Official Title
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Stimgenics Open-Label, Post Market Study: A Clinical Trial to Study the Effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) Programs in Treating Intractable Chronic Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: Stimgenics SCS Programming Approach
* Device: Standard SCS Programming Approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain) Has an average back pain intensity ≥ 5.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment with moderate to severe chronic leg pain Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided. Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English. Be 18 years of age or older at the time of enrollment Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study Be willing to not increase pain medications from baseline through the 3-Month Visit Be willing and able to comply with study-related requirements, procedures, and visits Exclusion Criteria: Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator Be concurrently participating in another clinical study Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc. Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator Has mechanical spine instability as determined by the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Arm<br>Subjects randomized to this arm will receive test treatment | Device: Stimgenics SCS Programming Approach<br>* Stimgenics SCS Programming approach Using Intellis(TM) SCS system<br>|
| Active Comparator: Control Arm<br>Subjects randomized to this arm will receive control treatment | Device: Standard SCS Programming Approach<br>* Standard SCS Programming approach using Intellis(TM) SCS system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Individual Responders | Percentage of Participants with a 50% decrease in back pain at 3 months compared to baseline. Pain rating will be measured on the 10 cm Visual Analog Scale (VAS). Change in back pain score will be used to determine individual responder (e.g., 50% reduction in VAS compared to Baseline VAS). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Individual Responders | The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority | 3 months | 
| Change in Back Pain Score | Comparison of change from Baseline in back pain score (using Visual Analog Scale 0.0-10.0cm) determined at the 3- and 6-month visit after device activation, between test and control in a statistical test of non-inferiority. This is calculated as: Change from Baseline in Back Pain VAS = 3-Month Visit Pain VAS - Baseline Pain VAS. | 3 months | 
| 6 Months Comparison of Back Pain Treatment Success | Comparison of Back Pain Treatment Success (responder rate), measured as subjects with at least a 50% reduction in Back Pain Visual Analog Scale (VAS), evaluated at 6 months after device activation, between test and control | 6 months | 
| Oswestry Disability Index (ODI) | Oswestry Disability Index (ODI) evaluated at 3 months visit | 3 months | 
| Adverse Events | Frequency of treatment emergent adverse events | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back Pain, Spinal Cord Stimulation