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Trial record 1 of 1 for:
SUNBURST
SUNBURST (Success Using Neuromodulation With BURST) Study (SUNBURST)
This study has been completed.
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT02011893
First received: December 10, 2013
Last updated: May 17, 2017
Last verified: May 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Chronic Pain | Device: Tonic Stimulation Device: Burst Stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Success Using Neuromodulation With BURST (SUNBURST™) Study |
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain [ Time Frame: Over 7 days after 3 months of treatment of burst or tonic 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, 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.
Secondary Outcome Measures:
- Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS) [ Time Frame: Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation ]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.
- Percentage of Paresthesia Coverage [ Time Frame: During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation ]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.
- Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation [ Time Frame: Over 7 days after 3 months of treatment of burst or tonic 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.
| Enrollment: | 173 |
| Study Start Date: | December 2013 |
| Study Completion Date: | January 2017 |
| Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Burst Stimulation
Burst Stimulation using the Prodigy system
|
Device: Burst Stimulation
Prodigy Neurostimulation System with associated components
|
|
Active Comparator: Tonic Stimulation
Tonic Stimulation using the Prodigy system
|
Device: Tonic Stimulation
Prodigy Neurostimulation System with associated components
|
Eligibility| Ages Eligible for Study: | 22 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02011893
Please refer to this study by its ClinicalTrials.gov identifier: NCT02011893
Locations
| United States, California | |
| Newport Beach Headache and Pain | |
| Mission Viejo, California, United States, 92691 | |
| Napa Biomedical Services | |
| Napa, California, United States, 94558 | |
| Eisenhower Desert Orthopedic Center | |
| Rancho Mirage, California, United States, 92270 | |
| IPM Medical Group | |
| Walnut Creek, California, United States, 94598 | |
| United States, Indiana | |
| Goodman Campbell Brain and Spine | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Bronson Neuroscience Center | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Mississippi | |
| The Neuroscience Center | |
| Biloxi, Mississippi, United States, 39531 | |
| Jackson Pain Center | |
| Jackson, Mississippi, United States, 39202 | |
| Comprehensive Pain & Rehabilitation | |
| Pascagoula, Mississippi, United States, 39581 | |
| United States, Missouri | |
| Midwest Neurosurgery Associates | |
| Kansas City, Missouri, United States, 64132 | |
| United States, Montana | |
| The Montana Center for Wellness & Pain Management | |
| Kalispell, Montana, United States, 25301 | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| New York Spine & Wellness Center | |
| North Syracuse, New York, United States, 13212 | |
| United States, Oklahoma | |
| Oklahoma Pain Physicians | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Oregon | |
| NeuroSpine Institute | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| St. Luke's Hospital | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| United States, South Carolina | |
| Clinical Trials of South Carolina | |
| North Charleston, South Carolina, United States, 29406 | |
| United States, Texas | |
| Houston Pain Centers | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Utah Spine Care | |
| Ogden, Utah, United States, 84403 | |
| United States, West Virginia | |
| The Center for Pain Relief | |
| Charleston, West Virginia, United States, 25301 | |
Sponsors and Collaborators
St. Jude Medical
Investigators
| Study Chair: | Timothy Deer, MD | The Center for Pain Relief |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT02011893 History of Changes |
| Other Study ID Numbers: |
C-12-07 |
| Study First Received: | December 10, 2013 |
| Results First Received: | February 1, 2017 |
| Last Updated: | May 17, 2017 |
| Studies a U.S. FDA-regulated Device Product: | Yes | |
Additional relevant MeSH terms:
|
Chronic Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on August 22, 2017