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Trial record 1 of 1 for:    SUNBURST
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SUNBURST (Success Using Neuromodulation With BURST) Study (SUNBURST)

This study has been completed.
Sponsor:
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
  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

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