The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Implantable Neurostimulator with Neuro Sense
Sydney Pain Specialists
Bella Vista, New South Wales, Australia
Genesis Research Services
Broadmeadow, New South Wales, Australia
Australian Medical Research
Hurstville, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Reduction in Overstimulation Sensation
The primary outcome is the proportion of low-back and/or leg pain subjects whose average overstimulation intensity score with Closed Loop On is less than their average overstimulation intensity score with Closed Loop Off. During in-clinic testing, subjects perform protocol prescribed activities and rate the intensity of the sensations on a 5-point Likert scale with both Closed Loop On and Off. The average overstimulation intensity scores within each subject are calculated separately for Closed Loop On and Off, and the proportion of subjects with a lower average overstimulation intensity score during Closed Loop On compared to their overstimulation intensity score during Closed Loop Off is calculated with a one-sided 97.5% lower bound.
Time frame: 30 days from device activation
Responder Rate for Treatment of Overall Pain
Responder rate defined as a reduction in Overall (back/leg) pain VAS of at least 50%.
Time frame: 3 months from device activation
Responder Rate for Treatment of Low-back Pain
Responder rate defined as a reduction in back pain VAS of at least 50%.
Time frame: 3 months from device activation
Responder Rate for Treatment of Leg Pain
Responder rate defined as a reduction in leg pain VAS of at least 50%.
Time frame: 3 months from device activation
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Sydney Pain Research Centre
Wahroonga, New South Wales, Australia
Sunshine Coast Clinical Research
Noosa, Queensland, Australia
Precision Brain Spine and Pain Center
Kew, Victoria, Australia