A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral Neuropathy

Study Overview
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Brief Summary
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10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy

Official Title
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A Post Market Cohort With the Commercially Available Spinal Modulation Neurostimulator System for the Management of Peripheral Neuropathy

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Device: Implantation with the commercially available Axium neurostimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years old Subject is able and willing to comply with the follow-up schedule and protocol Peripheral neuropathy for at least 6 months Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device Subject is able to provide written informed consent Exclusion Criteria: Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control Escalating or changing pain condition within the past month as evidenced by investigator examination 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 dorsal root ganglion within the past 3 months Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump Subject is unable to operate the device Subjects currently has an active infection Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated subjects<br>All subjects recruited and treated with the Axium neurostimulator | Device: Implantation with the commercially available Axium neurostimulator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain). | Baseline, 3, 6 and 12-Month Visits | 
| Percentage of Subjects With at Least 50% Pain Reduction | Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum). | 3, 6 and 12-Month Visits |