Trial record 1 of 2 for:
SUNBURST
SUNBURST (Success Using Neuromodulation With BURST) Study (SUNBURST)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02011893 |
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Recruitment Status :
Completed
First Posted : December 13, 2013
Results First Posted : May 18, 2017
Last Update Posted : January 30, 2019
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Pain | Device: Tonic Stimulation Device: Burst Stimulation | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 173 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Success Using Neuromodulation With BURST (SUNBURST™) Study |
| Study Start Date : | December 2013 |
| Actual Primary Completion Date : | January 2016 |
| Actual Study Completion Date : | January 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Burst Stimulation
Burst Stimulation using the Prodigy system
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Device: Burst Stimulation
Prodigy Neurostimulation System with associated components |
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Active Comparator: Tonic Stimulation
Tonic Stimulation using the Prodigy system
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Device: Tonic Stimulation
Prodigy Neurostimulation System with associated components |
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.
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| Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
| 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011893
Locations
Show 20 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
| Study Chair: | Timothy Deer, MD | The Center for Pain Relief |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Abbott Medical Devices |
| ClinicalTrials.gov Identifier: | NCT02011893 |
| Other Study ID Numbers: |
C-12-07 |
| First Posted: | December 13, 2013 Key Record Dates |
| Results First Posted: | May 18, 2017 |
| Last Update Posted: | January 30, 2019 |
| Last Verified: | January 2019 |
| Studies a U.S. FDA-regulated Device Product: | Yes |
Additional relevant MeSH terms:
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Chronic Pain Pain Neurologic Manifestations |