Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial Multicenter Study Comparative Study
Multicenter, Randomized, Double-Blind Study Protocol Using Human Spinal Cord Recording Comparing Safety, Efficacy, and Neurophysiological Responses Between Patients Being Treated With Evoked Compound Action Potential-Controlled Closed-Loop Spinal Cord Stimulation or Open-Loop Spinal Cord Stimulation (the Evoke Study).
The spinal cord (SC) response to stimulation has yet to be studied in a pivotal clinical study. We report the study design of an ongoing multicenter, randomized, double-blind, controlled, parallel-arm study of an evoked compound action potential (ECAP) controlled closed-loop spinal cord stimulation (SCS) system, which aims to gain U.S. Food and Drug Administration approval. ⋯ All approved SCS therapies, regardless of the presence or absence of stimulation induced paresthesias, produce fixed-output stimuli; that is, the energy delivered from the electrode array has a defined output irrespective of the neural response of SC fibers. An SCS system has been developed that directly measures the neurophysiologic activation of the SC to stimulation (i.e., ECAP amplitude) and uses this information in a feedback mechanism to produce closed-loop SCS to maintain optimal and stable activation of the SC. This study represents the first randomized, double-blind, pivotal study in the field of neuromodulation to measure SC activation in ECAP-controlled closed-loop versus open-loop stimulation and is expected to yield important information regarding differences in safety, efficacy, and neurophysiological properties. The potential clinical utility of these objective measurements of SC activation and other neurophysiological properties promises to improve outcomes of SCS for chronic pain patients.
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Currently little objective evidence exists regarding the phenotype or somato-sensory profile of patients with Failed Back Surgery Syndrome (FBSS). The aim of this study is to characterize the somato-sensory profile of the patients with FBSS undergoing spinal cord stimulation (SCS). ⋯ Although very low numbers, we could demonstrate the somatosensory profiles of patients with FBSS undergoing SCS. Early indication may associate an efficient CPM profile having a higher chance of an unsuccessful implant at three months.
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Placement of spinal cord stimulation (SCS) paddles under general anesthesia using intraoperative neuromonitoring (IONM) has been shown to be associated with equivocal or superior clinical outcomes in comparative studies. The value of IONM in percutaneous permanent SCS placement has not been demonstrated. ⋯ Permanent percutaneous implantation of a SCS system using IONM with general anesthesia demonstrates results within range to those in the literature. Patients demonstrated statistically significant improvement in outcomes and opioid use was reduced in 71% of patients who were using opioids at baseline. We recommend its use in patients with morbid obesity, sleep apnea, and considerable anxiety. Further research is warranted to define the possible future role for percutaneous SCS implantation under IONM.
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To explore the experience of spinal cord stimulation (SCS) for patients with failed back surgery syndrome (FBSS). ⋯ Overall, participants' understanding of SCS was limited. The value participants placed on understanding of the process varied markedly. A list of practical informational needs has been identified. Bespoke, user-friendly, informational tools should be developed from this list to enhance the patient experience of SCS.