Pilot Study to Examine the Feasibility of the Dynamic Interferential Spinal Cord Stimulation System™ (DISCSS™)

Study Overview
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Brief Summary
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This study evaluates use of DISCSS vis SCS. Thirty (30) patients with back pain greater than leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully completed a percutaneous trial with a commercially available SCS system will be trialed with a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5 U.S. centers. The percutaneous trial leads from the commercial system will be connected to the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for an additional three-four days.

Detailed Description
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This investigation will be performed as a prospective, multicenter, open-label feasibility study. Thirty (30) patients with back pain greater than leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully completed a percutaneous trial with a commercially available SCS system will be trialed with a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5 U.S. centers. The percutaneous trial leads from the commercial system will be connected to the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for an additional three to four days. The investigational product for this feasibility trial will be the DISCSS™ system, not the commercially available trial SCS system. Exposure to the commercially available trial SCS system will be considered background therapy. The purpose of the background therapy phase is to establish baseline pain levels and determine patients' eligibility to continue to the investigational phase of the trial using the DISCSS™ SCS phase of the trial. Pain assessment and complications data from the commercial spinal stimulation system will be collected during the background therapy phase. The pain and complications data from the background therapy phase will not be analyzed in terms of the study endpoints.

Official Title
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Pilot Study to Examine the Feasibility of the DISCSS™

Conditions
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Back Pain

Intervention / Treatment
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* Device: DISCSS Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 21 years and less than 80 years Has a diagnosis of chronic neuropathic pain of trunk and limbs Is eligible for and participating in a spinal cord stimulation trial of a commercially available SCS trial system. Subjects will be evaluated at the end of the background Commercial SCS Device phase for complications and appropriateness to continue to the investigational phase with the DISCSS™ system. Complications from the background phase with the commercial SCS device may include, but are not limited to unusual pain or discomfort during the trial stimulation, local skin reactions or infection at the implant site. Has a Back Pain Score of minimum intensity 5.0 on a Numeric Rating Scale (NRS) Has an NRS Back Pain Score that is greater than both Leg Pain Scores Is not a candidate for revision surgery Has completed a minimum of 6 weeks of conservative therapy (physical therapy, anti-inflammatory medications, or similar therapies) with limited or no reduction in back pain Is willing to adhere to the warnings associated with the DISCSS™ system Is willing to halt and/or modify the use of all prescription and over-the-counter analgesics per the Investigator's direction during study participation Is capable of providing written informed consent Is able to comply with the requirements of study visits, follow-up phone visits and self-assessment questionnaires Exclusion Criteria: Is a poor surgical candidate by determination of the Investigator Is unable to operate or understand the use of the commercial or investigational Spinal Cord Stimulator systems Has an active systemic infection Has exposure to shortwave, microwave or ultrasound diathermy at home or at work Has occupational exposure to high levels of non-ionizing radiation such as radio or cell phone transmission stations, facilities using radiofrequency heat sealers or induction heaters, or electric power infrastructure controlled environments Has an implanted cardiac system (e.g. pacemakers) Is currently participating in another clinical study Is currently pregnant or lactating, or not using adequate birth control Has any untreated major psychiatric comorbidity Has serious drug-related behavioral issues per Investigator's assessment Has a bleeding complication or coagulopathy Requires concurrent use of anticoagulant therapy such as heparin, warfarin, rivaroxaban, dabigatran, apixaban, edoxaban, enoxaparin, fondaparinux Is immunocompromised and at risk for infection Has insulin-dependent diabetes not controlled through diet and/or medication Has chronic pain related to malignancy Is otherwise determined, based on the opinion of the Investigator to be an unsuitable candidate for this study

Ages Eligible for Study
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Minimum Age: 21 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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, multi-center, open-label, feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DISCSS Device<br>This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system. | Device: DISCSS Device<br>* This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain reduction as compared to baseline | Patient-reported pain intensity on a Numeric Rating Scale (NRS) of 0-10 | Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of Pain | Patient-reported location of pain on anatomical map | Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11) | 
| Incidence of adverse events | Incidence of adverse events arising from the DISCSS treatment phase | Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11) | 
| Patient Satisfaction | Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire. | Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11) |