Neuromodulation : journal of the International Neuromodulation Society
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Multicenter Study Clinical Trial
Comparison of Paresthesia Mapping With Anatomic Placement in Burst Spinal Cord Stimulation: Long-Term Results of the Prospective, Multicenter, Randomized, Double-Blind, Crossover CRISP Study.
Spinal cord stimulation (SCS) is an effective therapy for chronic intractable pain. Conventional SCS involves electrode placement based on intraoperative paresthesia mapping; however, newer paradigms like burst may allow for anatomic placement of leads. Here, for the first time, we report the one-year safety and efficacy of burst SCS delivered using a lead placed with conventional, paresthesia mapping, or anatomic placement approach in subjects with chronic low back pain (CLBP). ⋯ This study demonstrated that equivalent clinical benefits could be achieved with burst SCS using either paresthesia mapping or anatomic landmark-based approaches for lead placement. Nonparesthesia-based approaches, such as anatomic landmark-based lead placement investigated here, have the potential to simplify implantation of SCS and improve current surgical practice.
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The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on the use of neurostimulation in the cervical region to improve outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for an often-overlooked area of neurostimulation practice. ⋯ The NACC recommends best practices regarding the use of cervical neuromodulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be utilized as a guide to assist decision making when clinically appropriate.
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DeRidder's burst stimulation design has become a key spinal cord stimulation (SCS) waveform because it reduces the intensity of pain as well as its associated emotional distress. The brain pathways underlying these outcomes may also allow for the effects of stimulation to carry over after stimulation is turned off, making it amenable to intermittent application. Here, the utility of intermittently cycled burst was evaluated using data from two large real-world prospective studies (TRIUMPH, REALITY). ⋯ Intermittent cycling of burst SCS lowers the overall electric charge delivered to the spinal cord and preserves battery consumption, without compromising pain relief and associated symptoms.
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Multicenter Study
The Link Between Spinal Cord Stimulation and the Parasympathetic Nervous System in Patients With Failed Back Surgery Syndrome.
In patients with chronic pain, a relative lower parasympathetic activity is suggested based on heart rate variability measurements. It is hypothesized that spinal cord stimulation (SCS) is able to influence the autonomic nervous system. The aim of this study is to further explore the influence of SCS on the autonomic nervous system by evaluating whether SCS is able to influence skin conductance, blood volume pulse, heart rate, and respiration rate. ⋯ Parameters that are regulated by the sympathetic nervous system were not significantly different between SCS on and off states, leading to the hypothesis that SCS is capable of restoring the dysregulation of the autonomic nervous system by primarily increasing the activity of the parasympathetic system in patients with FBSS.
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Multicenter Study
Exploration of High- and Low-Frequency Options for Subperception Spinal Cord Stimulation Using Neural Dosing Parameter Relationships: The HALO Study.
Subperception spinal cord stimulation (SCS) is described mostly utilizing waveforms that require high energy. However, the necessity of these waveforms for effective subperception has not been established. We aimed to explore whether effective subperception pain relief can be achieved using frequencies below 1 kHz. ⋯ We have derived an electric field configuration and, along with previous learnings in the kHz range, a set of neural dosing parameter relationships (10-10,000 Hz), which enable the expansion of effective subperception SCS to low frequency and achieve major energy savings.