SUNBURST (Success Using Neuromodulation With BURST) Study

Abbott

Status

Completed

Conditions

Chronic Pain

Treatments

Device: Tonic Stimulation

Device: Burst Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT02011893

C-12-07

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

All

Ages

22+ years old

Volunteers

No 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
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)