SUNBURST (Success Using Neuromodulation With BURST) Study (SUNBURST)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Burst Stimulation; Device: Tonic Stimulation

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 92691
      • Newport Beach Headache and Pain
    • Napa, California, United States, 94558
      • Napa Biomedical Services
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Desert Orthopedic Center
    • Walnut Creek, California, United States, 94598
      • IPM Medical Group
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Goodman Campbell Brain and Spine
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Neuroscience Center
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • The Neuroscience Center
    • Jackson, Mississippi, United States, 39202
      • Jackson Pain Center
    • Pascagoula, Mississippi, United States, 39581
      • Comprehensive Pain & Rehabilitation
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Midwest Neurosurgery Associates
  • Montana
    • Kalispell, Montana, United States, 25301
      • The Montana Center for Wellness & Pain Management
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • North Syracuse, New York, United States, 13212
      • New York Spine & Wellness Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Pain Physicians
  • Oregon
    • Eugene, Oregon, United States, 97401
      • NeuroSpine Institute
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Pain Centers
  • Utah
    • Ogden, Utah, United States, 84403
      • Utah Spine Care
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Center for Pain Relief

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain	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.	Over 7 days after 3 months of treatment of burst or tonic stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)	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.	Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation
Percentage of Paresthesia Coverage	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.	During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation
Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst 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.	Over 7 days after 3 months of treatment of burst or tonic stimulation

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Timothy Deer, MD, The Center for Pain Relief

Publications and helpful links

General Publications

• Slavin KV, North RB, Deer TR, Staats P, Davis K, Diaz R. Tonic and burst spinal cord stimulation waveforms for the treatment of chronic, intractable pain: study protocol for a randomized controlled trial. Trials. 2016 Dec 1;17(1):569. doi: 10.1186/s13063-016-1706-5.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: C-12-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes