SUNBURST (Success Using Neuromodulation With BURST) Study

NCT02011893 | Completed Results FDA Device

• 1 other identifier: C-12-07
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 20

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)

  Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation

• Percentage of Paresthesia Coverage

  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

  Over 7 days after 3 months of treatment of burst or tonic stimulation

Study Arms (2)

Burst Stimulation

EXPERIMENTAL

Burst Stimulation using the Prodigy system

Device: Burst Stimulation

Tonic Stimulation

ACTIVE COMPARATOR

Tonic Stimulation using the Prodigy system

Device: Tonic Stimulation

Interventions

Tonic Stimulation DEVICE

Prodigy Neurostimulation System with associated components

Tonic Stimulation

Burst Stimulation DEVICE

Prodigy Neurostimulation System with associated components

Burst Stimulation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (20)

Newport Beach Headache and Pain

Mission Viejo, California, 92691, United States

Location

Napa Biomedical Services

Napa, California, 94558, United States

Location

Eisenhower Desert Orthopedic Center

Rancho Mirage, California, 92270, United States

Location

IPM Medical Group

Walnut Creek, California, 94598, United States

Location

Goodman Campbell Brain and Spine

Indianapolis, Indiana, 46202, United States

Location

Bronson Neuroscience Center

Kalamazoo, Michigan, 49007, United States

Location

The Neuroscience Center

Biloxi, Mississippi, 39531, United States

Location

Jackson Pain Center

Jackson, Mississippi, 39202, United States

Location

Comprehensive Pain & Rehabilitation

Pascagoula, Mississippi, 39581, United States

Location

Midwest Neurosurgery Associates

Kansas City, Missouri, 64132, United States

Location

The Montana Center for Wellness & Pain Management

Kalispell, Montana, 25301, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

New York Spine & Wellness Center

North Syracuse, New York, 13212, United States

Location

Oklahoma Pain Physicians

Oklahoma City, Oklahoma, 73120, United States

Location

NeuroSpine Institute

Eugene, Oregon, 97401, United States

Location

St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Clinical Trials of South Carolina

North Charleston, South Carolina, 29406, United States

Location

Houston Pain Centers

Houston, Texas, 77030, United States

Location

Utah Spine Care

Ogden, Utah, 84403, United States

Location

The Center for Pain Relief

Charleston, West Virginia, 25301, United States

Location

Related Publications (1)

• 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.

  PMID: 27906080 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Roni Diaz, Director Clinical Studies
• Organization: St. Jude Medical

RDiaz@sjm.com

972-309-8601

Study Officials

• Timothy Deer, MD

  The Center for Pain Relief

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 30, 2019
• Results First Posted: May 18, 2017

Record last verified: 2019-01

Locations

US (20)