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Completed

NCT Number: NCT02011893

SUNBURST (Success Using Neuromodulation With BURST) 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.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Newport Beach Headache and Pain, Mission Viejo, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tonic Stimulation

Device

Prodigy Neurostimulation System with associated components

Burst Stimulation

Device

Prodigy Neurostimulation System with associated components

Primary outcomes

  1. Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain

    Time frame: Over 7 days after 3 months of treatment of burst or tonic 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, 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.

Secondary outcomes

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

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

    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.

  2. Percentage of Paresthesia Coverage

    Time frame: During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation

    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.

  3. Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation

    Time frame: Over 7 days after 3 months of treatment of burst or tonic 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Success Using Neuromodulation With BURST (SUNBURST™) Study

Acronym: SUNBURST

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 13, 2013
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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