Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial
Potential Therapeutic Effect of Low Amplitude Burst Spinal Cord Stimulation on Pain.
The SUNBURST Study, a USA-based controlled cross-over trial demonstrated that burst spinal cord stimulation was superior compared to tonic stimulation in suppressing chronic intractable pain. However, when on burst stimulation, participants preferred lower to higher amplitudes. This led to the hypothesis that lower burst amplitudes will correlate with lower pain scores while higher amplitudes will be associated with higher pain scores. ⋯ In burst spinal cord stimulation, in contrast to tonic stimulation, lower amplitudes are more effective in suppressing pain than high amplitudes.
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Ten kilohertz spinal cord stimulation (SCS) is usually initiated in a single-bipolar configuration over the radiological reference point T9/T10 intervertebral disc space for neuropathic back and leg pain. Cascade is a duty-cycled, multi-bipolar contact configuration across an entire eight-contact lead. Potential advantages by using a broader area of SCS coverage include mitigation against minor lead migration and a reduction in the need for reprogramming. We report here the results of a retrospective case series of 114 patients using Cascade. ⋯ Cascade is an effective programming methodology that may have benefits over a single-bipole configuration for 10 kHz SCS, particularly during a trial of stimulation. Results from this study suggest it is a durable program for patients with neuropathic back and leg pain.
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Spinal cord stimulation (SCS) is nowadays available with several stimulation paradigms. New paradigms, such as high dose (HD-)SCS, have shown the possibility to salvage patients who lost their initial pain relief. The first aim of this study is to evaluate the effectiveness of HD-SCS after conversion from standard SCS. The second aim is to develop a model for prediction of long-term response of HD-SCS after unsatisfactory standard SCS. ⋯ Converting patients with unsatisfactory responses from standard SCS to HD-SCS may be an effective strategy to obtain and maintain pain relief in a challenging subgroup of patients with FBSS refractory to standard SCS. The prediction models may guide clinicians in their decision making when considering conversion to HD-SCS in patients with FBSS experiencing inadequate response to standard SCS.
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Multicenter Study
Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation.
Intermittent dosing (ID), in which periods of stimulation-on are alternated with periods of stimulation-off, is generally employed using 30 sec ON and 90 sec OFF intervals with burst spinal cord stimulation (SCS). The goal of this study was to evaluate the feasibility of using extended stimulation-off periods in patients with chronic intractable pain. ⋯ ID burst SCS effectively relieved pain for six months. The largest group of subjects used IDB settings of 30 sec ON and 360 sec OFF. These findings present intriguing implications for the optimal "dose" of electricity in SCS and may offer many advantages such as optimizing the therapeutic window, extending battery life, reducing recharge burden and, potentially, mitigating therapy habituation or tolerance.
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Review
Clinical Trial Designs for Neuromodulation in Chronic Spinal Cord Injury Using Epidural Stimulation.
This is a narrative review focused on specific challenges related to adequate controls that arise in neuromodulation clinical trials involving perceptible stimulation and physiological effects of stimulation activation. ⋯ Standard of care control groups fail to control for the multiple effects of knowledge of having undergone surgical procedures, having implanted stimulation systems, and being observed in a clinical trial. The irreducible effects that have been identified as "placebo" require sham controls or comparison groups in which both are implanted with potentially active devices and undergo similar rehabilitative training.