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

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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.


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
Charleston, West Virginia 25301
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Charleston, WV
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Albany, New York 12208
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Albany, NY
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Bethlehem, Pennsylvania 18015
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from
Bethlehem, PA
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Biloxi, Mississippi 39531
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from
Biloxi, MS
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Eugene, Oregon 97401
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from
Eugene, OR
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46202
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from
Indianapolis, IN
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Jackson, Mississippi 39202
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from
Jackson, MS
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Kalamazoo, Michigan 49007
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Kalamazoo, MI
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Kalispell, MT
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Kansas City, Missouri 64132
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Kansas City, MO
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Mission Viejo, California 92691
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from
Mission Viejo, CA
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Napa, California 94558
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from
Napa, CA
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North Charleston, South Carolina 29406
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from
North Charleston, SC
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North Syracuse, New York 13212
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from
North Syracuse, NY
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Ogden, Utah 84403
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from
Ogden, UT
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Oklahoma City, Oklahoma 73210
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from
Oklahoma City, OK
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Pascagoula, Mississippi 39581
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from
Pascagoula, MS
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Rancho Mirage, California 92270
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Rancho Mirage, CA
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Walnut Creek, California 94598
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from
Walnut Creek, CA
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