SUNBURST (Success Using Neuromodulation With BURST) Study

Chronic Pain Clinical Trial

— SUNBURST  

Official title:

Success Using Neuromodulation With BURST (SUNBURST™) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011893
• Other study ID #: C-12-07
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Tonic Stimulation
Prodigy Neurostimulation System with associated components
• Burst Stimulation
Prodigy Neurostimulation System with associated components

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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