SUNBURST (Success Using Neuromodulation With BURST) Study

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT02011893

Run by

Abbott Medical Devices

People needed

173

Starts

2013-12-01

Expected to finish

2017-01-01

Last updated by the study team

2019-01-30

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Newport Beach Headache and Pain — Mission Viejo, California, United States
• Napa Biomedical Services — Napa, California, United States
• Eisenhower Desert Orthopedic Center — Rancho Mirage, California, United States
• IPM Medical Group — Walnut Creek, California, United States
• Goodman Campbell Brain and Spine — Indianapolis, Indiana, United States
• Bronson Neuroscience Center — Kalamazoo, Michigan, United States
• The Neuroscience Center — Biloxi, Mississippi, United States
• Jackson Pain Center — Jackson, Mississippi, United States
• Comprehensive Pain & Rehabilitation — Pascagoula, Mississippi, United States
• Midwest Neurosurgery Associates — Kansas City, Missouri, United States
• The Montana Center for Wellness & Pain Management — Kalispell, Montana, United States
• Albany Medical Center — Albany, New York, United States
• New York Spine & Wellness Center — North Syracuse, New York, United States
• Oklahoma Pain Physicians — Oklahoma City, Oklahoma, United States
• NeuroSpine Institute — Eugene, Oregon, United States
• St. Luke's Hospital — Bethlehem, Pennsylvania, United States
• Clinical Trials of South Carolina — North Charleston, South Carolina, United States
• Houston Pain Centers — Houston, Texas, United States
• Utah Spine Care — Ogden, Utah, United States
• The Center for Pain Relief — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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