SUNBURST (Success Using Neuromodulation With BURST) Study
Status: | Completed |
---|---|
Conditions: | Chronic Pain, Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 2/1/2019 |
Start Date: | December 2013 |
End Date: | January 2017 |
Success Using Neuromodulation With BURST (SUNBURST™) Study
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.
the treatment of chronic intractable pain of the trunk and/or limbs.
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)
We found this trial at
20
sites
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