Medtronic Closed-Loop Spinal Cord Stimulation System

Study Overview
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Brief Summary
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The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.

Official Title
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Evaluation of Long-term Patient Experience With a Medtronic Closed-Loop Spinal Cord Stimulation System

Conditions
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Low Back Pain, Leg Pain, Upper Limb Pain

Intervention / Treatment
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* Device: Inceptiv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs If being treated for low-back and/or leg pain, the baseline overall^ Visual Analog Scale is ≥ 60 mm and baseline back and/or leg pain Visual Analog Scale is ≥60 mm. ^Average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using Visual Analog Scale. If being treated for upper limb pain - baseline Visual Analog Scale is ≥ 60 mm for upper limb pain On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial Willing and able to provide signed and dated informed consent Willing and able to comply with all study procedures and visits Exclusion Criteria: Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator Pregnant or planning on becoming pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal) Be involved in an injury claim or under current litigation

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: Inceptiv<br>* Implantable Neurostimulator with Neuro Sense<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in overstimulation sensation | Comparison of Neuro Sense On vs Off at in-clinic testing for low-back and/or leg pain subjects. Subjects will perform protocol prescribed activities and rate the intensity of the sensation on a 5-point Likert scale. The average intensity scores during each period will be calculated for each subject. The proportion of low-back and leg pain subjects with a reduction in overstimulation sensation during Neuro Sense On compared to Neuro Sense Off will be calculated, with a one-sided 97.5% lower bound. | 30 days from device activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate for treatment of overall pain | Low-back and/or leg pain subjects | 3 months from device activation | 
| Responder rate for treatment of low-back pain | Low-back pain subjects (baseline back VAS ≥60mm) | 3 months from device activation | 
| Responder rate for treatment of leg pain | Leg pain subjects (baseline leg VAS ≥60mm) | 3 months from device activation |