Wireless Spinal Cord Stimulation for Chronic Pain

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain

Detailed Description
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This is a multi-center, prospective study in which subjects will receive a Freedom SCS System and to receive stimulation at a frequency between 5 Hz to 1500 Hz . Enrollment will continue until 49 subjects have been implanted. Subjects will have chronic back or back and leg pain refractory to standard medical treatment associated with Failed Back Surgery Syndrome (FBSS). Subjects will be followed for a 6-month period after a maximum one-month trial period. At the end of 6 months follow-up, all subjects will assess the outcomes of their appointed therapy and continue with long-term use of the system. Stimulators will be placed at the following sites to target the painful area: • Epidural Space midline covering vertebrae levels T8 through T11 (one stimulator placed at the top of T8 and the second stimulator placed at the middle of T9). Paresthesia mapping will be utilised to determine the optimal location for stimulation of the painful area.

Official Title
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Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain

Conditions
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Back Pain

Intervention / Treatment
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* Device: Freedom SCS System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years of age at time of informed consent; Subjects have been diagnosed with chronic back or back and leg pain with an average VAS > 5 (on a 10 scale) over the course of the last month for back pain based on baseline pain diary; Subject diagnosis with chronic back or back and leg pain associated with FBSS refractory to conventional medical management for at least 12 months prior to enrollment; Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment; Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject; Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses; Based on the opinion of the implanter, subject is a good surgical subject for the implant procedure; Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements; Subject is male or non-pregnant female; Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures; Subject is capable of giving informed consent; Subject lives within reasonable distance from the study site (circumference of 50 miles). Exclusion Criteria: Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months); Unresolved Malignancies in last six months; Subject has post-herpetic neuralgia (shingles); Subject has an active systemic infection or is immune-compromised; Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study; Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study; Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication; Bleeding complications or coagulopathy issues; Pregnant/lactating or not using adequate birth control; A life expectancy of less than one year; Any active implanted device whether turned off or on; A previous SCS experience; Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.

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: Freedom SCS System - 1500 HZ<br>Epidural Space covering vertebrae level T8-T11 determined by paresthesia mapping for painful area. | Device: Freedom SCS System<br>* This Freedom SCS System is based on wireless neuromodulation technology. This technology includes octapolar stimulators with embedded receivers. The energy source is a small, external, rechargeable transmitter, which is worn by the subject. The device is programmed to have a 5-1500 Hz therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | A 50% reduction in VAS scores when compared to baseline. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in VAS Back from baseline | The percentage reduction in VAS back pain | 6 Months | 
| Percentage change in VAS Leg from baseline | The percentage reduction in VAS leg pain | 6 Months | 
| Oswestry Disability Index (ODI) Score | The change from baseline in functionality using the ODI | 6 Months | 
| Patient Satisfaction | The change in satisfaction as measured by Patient Global Impression of Change | 6 Months | 
| Disability Score | The change in European Quality of Life 5 Dimension | 6 Months | 
| Sleep Quality | Frequency of sleep disturbances reported from diary | 6 Months | 
| Procedure time | The time measured to implant the device from operative notes | 7 Days post implant | 
| Opioid Reduction | The reduction in opioids as reported by patient prescription | 6 Months | 
| Adverse Events | The incidence of device related adverse events | 6 Months |