Neuromodulation : journal of the International Neuromodulation Society
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Introduction. Since its first application in 1967, numerous case series indicate that spinal cord stimulation (SCS) is an effective treatment for the management of failed back surgery syndrome (FBSS). However, only one randomized controlled trial has demonstrated that SCS provides more effective pain relief than re-operation and conventional medical management. The PROCESS randomized, controlled, multicenter trial aims to assess the clinical effectiveness and cost-effectiveness of SCS when added to conventional medical management compared to conventional medical management alone in patients with FBSS. ⋯ At the 6-month visit, patients will be classified as successful (≥ 50% pain relief in the legs) or unsuccessful (< 50% pain relief in the legs). If the results of the randomized treatment are unsuccessful, patients can cross over to the alternative treatment arm. Discussion. This paper highlights the rationale, design, methods, and challenges of an ongoing prospective, randomized, controlled, multicenter clinical trial that has been undertaken to obtain conclusive evidence of the clinical efficacy and cost-effectiveness of an SCS system in patients with FBSS.
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Objectives. Recent publications on dual program spinal cord stimulation (SCS) system demonstrate more flexible electrode programming, which helps to steer paresthesias towards all of the affected areas including the low back area. Materials and Methods. The following data were retrospectively sought from 20 nonrandomized failed back surgery patients at two centers treated by a dual quadripolar surgically implanted SCS lead: pain and paresthesia, VAS ratings, medication use, sleep patterns, daily activities, hardware problems, and willingness to repeat the procedure. The data were analyzed by the Wilcoxon signed rank test (p value < 0.05). ⋯ The number of patients taking benzodiazepines decreased. Sixty percent reported increased participation in social activities. Conclusions. This dual program surgical SCS technique is simple, respects patients' autonomy, and provides adequate analgesia with an increase in quality of life.
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Objectives. To document epileptiform discharges recorded within a mammillary body (MB) of a patient with chronic refractory epilepsy (CRE). Materials and Methods. A 37-year-old man, whose epilepsy was not controlled by medication or vagus nerve stimulation, was enrolled in a study of the effects of deep brain stimulation of the MB and mammillothalamic tract (MTT) in CRE. Surface and deep EEG recordings were obtained for 3 days before implantation of the macroelectrodes and for 4 days after implantation of the macroelectrodes but before implantation of the stimulator battery. ⋯ When these discharges were longer than 100 sec, they spread to the right MTT area and then to the left MB and MTT area. Simultaneously, the patient became agitated and confused. Conclusions. This original observation indicates that subcortical neuronal structures, such as the MB, may sustain epileptiform discharges in humans.
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Objectives. Electric peripheral nerve stimulation (PNS) is a neuromodulatory therapy in pain patients. The efficacy of this neurosurgical pain treatment is controversial because its antinociceptive effect in humans has not been objectively proven so far. Materials and Methods. Noxious infrared laser stimulation of the left hand dorsum evoked cortical potentials (LEP) by selective excitation of Aδ-fiber nociceptors in 15 healthy volunteers under control and PNS conditions. ⋯ Results. During PNS, LEP amplitudes (p < 0.001) and laser intensity ratings (p < 0.05) significantly decreased, and LEP latencies significantly increased (p < 0.05). Under control conditions LEP and intensity ratings remained unchanged. Conclusions. The electrophysiologic data provide evidence that electric stimulation of peripheral Aβ-fibers reliably suppresses Aδ-fiber nociceptive processing in human volunteers.
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Introduction. Neuromodulation, mediated by invasive electric stimulation, has been shown to be effective when applied to patients with refractory and intractable neuropathic pain. Recent advances in neurostimulation have broadened the therapeutic uses of this therapy, with the placement of extraspinal electrodes for peripheral nerve stimulation. Methods. Four patients with long-evolving, persistent, severe, uncontrolled, and localized pain in the occipital region, in whom other management options had been tried and failed, were treated with a peripheral, occipital, extraspinal electric stimulation (C1-C2-C3). ⋯ Results. In all cases, stimulation of the occipital region yielded good or very good global results. In all patients, continuous pain disappeared, the frequency and severity of the episodic pain decreased, function improved, and restful sleep improved. As a result of stimulation we were either able to reduce or discontinue medication usage in all of our patients.