A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems

Study Overview
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Brief Summary
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12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.

Official Title
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A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the Axium® DoRsal Root Ganglion Stimulation System Versus the Prime Advanced Dorsal Column Stimulation System

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Treatment with the Axium SCS system
* Device: Treatment with the Medtronic SCS System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is appropriate for SCS implantation according to standard criteria Subject is >18 to <75 years old Subject is able and willing to comply with the follow-up schedule and protocol Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain Subject is able to provide written informed consent Exclusion Criteria: Subject has no other exclusion criteria for SCS implantation according to standard criteria Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days Subject has had radiofrequency treatment of an intended target DRG within the past 3 months Subject has participated in another clinical study within 30 days Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Axium SCS System<br>Implantation with the Axium Neurostimulator | Device: Treatment with the Axium SCS system<br> <br> |
| Active Comparator: Medtronic SCS System<br>Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System | Device: Treatment with the Medtronic SCS System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of Stimulation Induced Paresthesia | A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia | 3 Months post implantation | 
| Stability of Stimulation Induced Paresthesia | A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position | 3 Months post implantation | 
| Patient Interactions with System | A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily | 3 Months post implantation |