Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.

Official Title
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A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs.

Conditions
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Chronic Pain, Back Pain, Pain

Intervention / Treatment
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* Device: Evoke Spinal Cord Stimulator (SCS) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female between the ages of 18 and 80 years. Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months. Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator. Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits. Exclusion Criteria: Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS). Have prior experience with SCS. Have an active systemic infection or local infection in the area of the surgical site. Be pregnant or nursing (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 concomitantly participating in another clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evoke SCS with Feedback<br>closed-loop/automatic stimulation | Device: Evoke Spinal Cord Stimulator (SCS) System<br>* Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).<br>|
| Active Comparator: Evoke SCS with Conventional<br>open-loop/manual stimulation | Device: Evoke Spinal Cord Stimulator (SCS) System<br>* Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Composite Endpoint Success | The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Leg Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | 3 months | 
| Percent Change From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | 3 months | 
| Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | 3 months | 
| Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 3 months | 
| Number of Participants With Composite Endpoint Success | The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | 12 months | 
| Percent Change From Baseline in Leg Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 12 months | 
| Percent Change From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 12 months | 
| Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 12 months | 
| Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nervous System Diseases, Signs and Symptoms, SCS, Chronic Pain, Leg Pain, Back Pain, Pain, Neurologic Manifestations, Closed Loop