SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)

Study Overview
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Brief Summary
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This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach. The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.

Detailed Description
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This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional 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 DTM-SCS programming approach Control treatment group with Conventional 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. There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit. Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to include an estimated 135 subjects to the point of randomization. This would allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month endpoint. The expected total duration of this study is approximately 32 months.

Official Title
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Open-Label, Post Market Study: Study the Effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM™SCS) Programs in Treating Intractable Chronic Back Pain in Subjects Without Prior History of Spine Surgery

Conditions
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Chronic Back Pain

Intervention / Treatment
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* Device: DTM Programming
* Device: Conventional SCS programming


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 pain with or without leg pain) Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment 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 written questionnaires, and read, understand and sign the written inform consent. Be 18 years of age or older at the time of enrollment Be on a stable pain medication regimen, 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: Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) Has a medical, anatomical, and/or psycho-social condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and or neurological disorders, 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 a pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator Has mechanical spine instability as determined by the Investigator Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)

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
Interventional Model Description: Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: Test treatment group with DTM-SCS programming approach Control treatment group with Conventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DTM-SCS programming<br>This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Test treatments, which may identify the type of treatment to study participants. DTM-SCS programming has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms. | Device: DTM Programming<br>* DTM-SCS programming<br>|
| Active Comparator: Conventional SCS programming<br>This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Control treatments, which may identify the type of treatment to study participants. Conventional SCS programming is stimulation parameters in the 40-250 Hz frequency range and will be trialed according to standard practice as described in the Intellis labeling/manuals | Device: Conventional SCS programming<br>* Conventional SCS programming<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy | The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment. | 3 months |