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SUNBURST (Success Using Neuromodulation With BURST) Study | Clinical Trials | Clareo Health

COMPLETEDNA

SUNBURST (Success Using Neuromodulation With BURST) Study

Success Using Neuromodulation With BURST (SUNBURST™) Study

NCT02011893•Abbott Medical Devices

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (20)

Newport Beach Headache and Pain

Mission Viejo, California, United States

Napa Biomedical Services

Napa, California, United States

Eisenhower Desert Orthopedic Center

Rancho Mirage, California, United States

IPM Medical Group

Walnut Creek, California, United States

Goodman Campbell Brain and Spine

Indianapolis, Indiana, United States

Bronson Neuroscience Center

Kalamazoo, Michigan, United States

The Neuroscience Center

Biloxi, Mississippi, United States

Jackson Pain Center

Jackson, Mississippi, United States

Comprehensive Pain & Rehabilitation

Pascagoula, Mississippi, United States

Midwest Neurosurgery Associates

Kansas City, Missouri, United States

Key Dates

Start Date

December 1, 2013

Primary Completion Date

January 1, 2016

Completion Date

January 1, 2017

Last Updated

January 30, 2019

Enrollment

173

ACTUAL participants

Conditions

Chronic Pain

Interventions

Tonic Stimulation

DEVICE

Burst Stimulation

DEVICE

Optimization of NIBS for Treatment of Addiction

NCT04379115

Opioid-use DisorderChronic Pain

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RECRUITINGNA

VR Mindfulness Training for Veterans With SCI

NCT06587607

Spinal Cord InjuryChronic Pain

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SUNBURST (Success Using Neuromodulation With BURST) Study

Inclusion Criteria

Exclusion Criteria

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