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Burst Optimized Stimulation Study (NCT02896361)

Klinikum Duisburg GmbH
This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.
  • Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol
    Stimulation parameters are reprogrammed from original values to study defined ones
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;
    • Subject has been exclusively using burst stimulation for at least three months;
    • Subject is 18 years of age or older;
    • Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;
    • Subject agrees not to add or increase pain-related medication from enrollment through the study duration;
    • Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
    Exclusion Criteria:
    • Subject is currently participating in a clinical investigation study that includes an active treatment arm;
    • Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;
    • Subject has a non SJM neuromodulation device
    This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.

    Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.

    3 locations

    30 June, 2016
    04 September, 2017
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