SUNBURST (Success Using Neuromodulation With BURST) Study

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for the treatment of chronic intractable pain of the trunk and/or limbs.

Official Title
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Success Using Neuromodulation With BURST (SUNBURST™) Study

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Tonic Stimulation
* Device: Burst Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 22 years of age or older Subject has chronic intractable pain of the trunk and/or limbs Subject has a average score of 60 or higher for average daily overall pain on the Visual Analog Scale (VAS) 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 from activation through the 24 week follow-up visit Exclusion Criteria: Subject is currently participating in a clinical investigation that includes an active treatment arm Subject has been implanted with a previous neurostimulation system or participated in a trial period for a neurostimulation 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 screening visit Subject has an infusion pump or any implantable neurostimulator device Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment Subject has an existing medical condition that is likely to require repetitive Magnetic Resonance Imaging (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's pain originates from 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 urine/blood pregnancy test)

Ages Eligible for Study
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Minimum Age: 22 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Burst Stimulation<br>Burst Stimulation using the Prodigy system | Device: Burst Stimulation<br>* Prodigy Neurostimulation System with associated components<br>|
| Active Comparator: Tonic Stimulation<br>Tonic Stimulation using the Prodigy system | Device: Tonic Stimulation<br>* Prodigy Neurostimulation System with associated components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain | Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain. | Over 7 days after 3 months of treatment of burst or tonic stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS) | Number of subjects responding to Burst and Tonic Stimulation defined as 30% or greater decrease in overall Visual Analog Scale (VAS) score from baseline. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain. | Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation | 
| Percentage of Paresthesia Coverage | Paresthesia mapping (percentage of paresthesia coverage) analyzed to demonstrate the differences between Burst and Tonic Stimulation. Data is presented as areas of paresthesia reported while utilizing either Burst or Tonic Stimulation as a percentage of the total number of areas possible. | During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation | 
| Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation | Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation to evaluate for superiority of Burst Stimulation. Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain. | Over 7 days after 3 months of treatment of burst or tonic stimulation |