SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.

Official Title
-----------------
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain

Conditions
-----------------
Failed Back Surgery Syndrome, Post-Laminectomy Syndrome, Low Back Pain

Intervention / Treatment
-----------------
* Device: SCS and PNfS
* Device: SCS Alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subject is 22 years of age or older Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS) Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary Subject has attempted best medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation Subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation) Key Exclusion Criteria: Subject currently participating in a clinical investigation that includes an active treatment arm Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system Subject's overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit Subject with an infusion pump or any implantable neurostimulator device Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor) Subject has an existing medical condition that is likely to require the use of diathermy in the future Subject has peripheral vascular disease Subject is immunocompromised Subject has documented history of allergic response to titanium or silicone Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCS and PNfS<br>Eon or Eon Mini IPG with epidural leads in the spinal column and subcutaneous leads in the peripheral field | Device: SCS and PNfS<br>* Spinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.<br>* Other names: Eon or Eon Mini IPG neurostimulation system with associated components;|
| Active Comparator: SCS Alone<br>Eon or Eon Mini IPG with epidural leads in the spinal column | Device: SCS Alone<br>* Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.<br>* Other names: Eon or Eon Mini IPG neurostimulation system with associated components;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Evaluation of device or procedure related adverse events | 6 months | 
| Efficacy | Responder rate in SCS-PNfS vs SCS alone | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 3 months | 
| Functional Disability |  | 3 months | 
| Worst pain |  | 3 months | 
| Rescue medication usage |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Back Pain, Failed Back surgery Syndrome, Post-Laminectomy Syndrome, Spinal Cord Stimulation, Peripheral Nerve field Stimulation, Pain