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Objectives: This study aimed to investigate the correlation between the vertebral level of paddle placement and abdominal wall stimulation (AWS) after differential target multiplexed spinal cord stimulation (SCS) to improve the safety and effectiveness of SCS for patients with chronic pain, particularly those with low back pain (LBP)., Materials and Methods: The Correlation Between Abdominal Wall Stimulation and Spinal Cord Stimulator Tip Location study was a nonrandomized clinical trial that included 24 patients with SCS for persistent spinal pain syndrome (PSPS) type 2 (trial ID: NCT05565469). The intervention involved increasing stimulation amplitude to a maximum tolerable value and obtaining numerical rating scores for AWS. The primary outcome measure was the association between AWS, the neurostimulator tip, and conus medullaris location, whereas the secondary outcome was the pre-postinterventional difference in proportion of patients experiencing AWS. Patient demographics and postoperative imaging were assessed. Statistical analyses involved descriptive statistics, a descriptive logistic regression, and a McNemar test., Results: The results of the study showed that seven (29%) of the 24 patients experienced AWS either previously or during interventional stimulation. However, there was no significant correlation found between AWS and the location of the neurostimulator tip or conus medullaris, and there was no difference in the pre-postinterventional proportion of patients experiencing AWS., Conclusions: The study concludes that a relatively high proportion of patients who received SCS for PSPS type 2 experienced or previously experienced AWS. There was no significant correlation found between the location of the neurostimulator tip and the occurrence of AWS. This suggests that AWS may not be solely dependent on the stimulation itself and emphasizes the need to consider other factors. Nonetheless, this study provides important insights into the occurrence of AWS in patients receiving SCS for PSPS type 2 and highlights the need for further research in this area., Clinical Trial Registration: The Clinicaltrials.gov registration number for the study is NCT05565469., Competing Interests: Conflict of Interest The authors reported no conflict of interest., (Copyright © 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Cervical cord stimulation is used in the treatment of chronic (neuropathic) pain syndromes refractory to conservative treatments. Several authors describe different techniques for the placement of cervical electrodes. Electrodes can be placed retrogade [Correction added on 03 April 2018 after first online publication: the word "plased" has been changed to "placed".]. In this article, we describe a refinement on how to dissect the dorsal meningo-vertebral ligaments to decrease the risk of complications., Patients and Methods: Twenty-eight patients received a permanent cervical spinal cord stimulator. A C0-C1 retrograde insertion was performed with careful dissection of the meningo-vertebral ligaments. Complications were registered during the follow-up (mean 44.6 months [SD = 43, range 1-162 months])., Results: Six complications were observed 93% of the patients reported a significant reduction in pain., Conclusions: We describe an additional surgical detail for the known procedure for retrograde placement of high cervical plate electrodes. This surgical detail might result in a lower risk of complications. We present a case series of 28 patients to support this hypothesis., (© 2018 International Neuromodulation Society.)

Background: Fibromyalgia is a disorder distinguished by pervasive musculoskeletal pain that has pervasive effects on affected individuals magnifying the importance of finding a safe and viable treatment option., Objective: The goal of this study is to investigate if transcranial direct current stimulation (tDCS) treatment can predict the outcome of occipital nerve field stimulation (ONFS) via a subcutaneous electrode., Methods: Nine patients with fibromyalgia were selected fulfilling the American College of Rheumatology-90 criteria. The patients were implanted with a subcutaneous trial-lead in the C2 dermatome innervated by the occipital nerve. After the treatment phase of ONFS using a C2 implant, each patient participated in three sessions of tDCS. Stimulation outcomes for pain suppression were examined between the two methods to determine possible correlations., Results: Positive correlation of stimulation effect was noted between the numeric rating scale changes for pain obtained by tDCS treatments and short-term measures of ONFS, but no correlation was noted between tDCS and long-term ONFS outcomes. A correlation also was noted between short-term ONS C2 implant pain suppression and long-term ONS C2 implant treatment success., Conclusions: This pilot study suggests that tDCS is a predictive measure for success of OFNS in short-term but cannot be used as a predictive measure for success of long-term OFNS. Our data confirm previous findings that ONFS via an implanted electrode can improve fibromyalgia pain in a placebo-controlled way and exert a long-term pain suppression effect for ONFS via an implanted electrode., (© 2015 International Neuromodulation Society.)

Objective: Fibromyalgia causes widespread musculo-skeletal pain in the four quadrants of the body. Greater occipital nerve stimulation has recently shown beneficial effects in fibromyalgia patients on pain, fatigue, and mood disorders. Laser-evoked potentials (LEPs) are used for research to understand the pathophysiological mechanisms of pain and to evaluate the effects of pain treatment. In fibromyalgia patients, LEPs tend to have a higher N2 amplitude, a tendency to shorter latencies, and patients have a lower pain threshold. Greater occipital nerve stimulation might exert a modulation of the medial pain pathways processing the affective motivational components of pain (unpleasantness) as well as the descending pain inhibitory pathways (reducing pain), both of which are contributing to the N2P2 peak., Materials and Methods: To test this hypothesis, the authors performed LEPs in a group of fibromyalgia patients with and without greater occipital nerve stimulation., Results: Occipital nerve stimulation does not alter the amplitudes of the LEP recordings, although a significant difference in latencies can be seen. More specifically, latencies of the N2P2 increased in the condition after stimulation, and especially at the Pz electrode., Conclusion: Our results suggest Occipital Nerve Stimulation (ONS) induces a modification of the balance between antinociceptive pain inhibitory pathways and pain-provoking pathways., (© 2015 International Neuromodulation Society.)

Objective: The goal of this study is to evaluate the effectiveness of occipital nerve stimulation (ONS) as a surgical treatment for fibromyalgia in a placebo-controlled design., Materials and Methods: Eleven patients were selected based on the American College of Rheumatology-90 criteria and implanted with an occipital nerve trial-lead stimulator. Baseline scores for pain, mood, and fatigue were acquired, and patients were randomized in a ten-week double-blinded crossover design with placebo and effective subsensory threshold stimulation (no paresthesias). After finalizing the trial, nine patients were implanted permanently; evaluation was performed prior to surgery and at six months after surgery for pain, fatigue, and mood of the number of trigger points and overall morbidity., Results: Significant results were found during the trial for a decrease in pain intensity (39.74%) on visual analogue scale (VAS; p < 0.001) and pain catastrophizing scale (PCS) during effective stimulation. A total of 9/11 patients responded to trial treatment; however, in two patients, this might be a placebo effect, recognizable due to the study design. Six months after permanent implantation, pain intensity remained decreased (44.01%) on VAS (p < 0.05). Besides the VAS, significant changes were noted for PCS, fatigue (modified fatigue impact scale), the number of trigger points, and overall morbidity (fibromyalgia impact questionnaire). There were no serious adverse events., Conclusions: Our data strongly suggest that ONS is beneficial in the treatment of fibromyalgia. The beneficial effects are stable at six months after permanent implantation. Subsensory threshold stimulation is feasible in designing a placebo-controlled trial., (© 2013 International Neuromodulation Society.)

Objective: To evaluate the clinical efficacy of pain suppression in back area and lower extremities by recently developed plate electrodes for spinal cord stimulation through percutaneous access., Methods: A retrospective analysis is performed: 20 consecutive patients with both lower extremity pain and low back pain, with low back counting for at least 30% of the overall pain were implanted with a small profile plate type lead, S-Series (SJM), via percutaneous approach. Patients were asked to rate their back and leg pain as well as their overall satisfaction and data on quality of life (QOL) on a (0-10 point) visual analog scale (VAS) before and after implantation. Medication use, functional pain (pain when bending forward, moving), and patient satisfaction scores also were collected., Results: A significant reduction of 55% and 45.7% in, respectively, VAS legs and VAS back pain was found. One year postoperatively the reduction was still present, respectively, 43% and 27% for the legs and the back. In 17 patients (85%) a clinically relevant reduction (defined as reduction of 2 points or 30% in VAS) in back pain was seen, with a mean decrease of 4.3 points (2.0-10.0) or 52% (22-100). Only three patients had no reduction in back pain, although they had reduction of their pain in the lower extremities. A significant and clinically relevant improvement of 66% and 70% was seen, respectively, for general satisfaction and QOL, respectively. One year postoperatively this improvement was still present, respectively, 69% and 75% for the satisfaction and QOL. Importantly functional pain also decreased by 51%. No infections occurred. Mean duration of post-op wound pain was 13.5 hours., Conclusion: Percutaneous implantation of the S-Series plate electrodes using a 10 gauge epidural needle combines the advantages of a minimal invasive technique with the possibility to cover the back area supplementing leg coverage in 85% of the failed back surgery syndrome patients., (© 2011 International Neuromodulation Society.)

Objective: To study the central effects of occipital nerve stimulation (ONS) using functional magnetic resonance imaging (fMRI)., Materials and Methods: After phantom measurements, blocked design fMRI scanning was performed during intermittent ONS in a healthy volunteer with implanted electrodes connected to an external generator. To assess the effect of frequency and stimulation mode, seven different frequencies in either tonic or burst mode were generated by a neurostimulator., Results: A qualitative analysis of the main effect of ONS demonstrated significantly decreased activity within the bilateral primary visual, auditory, and somatosensory cortices and in the amygdala. Significant increased activity was observed bilaterally in the thalamus, frontal, and parietal areas and the cerebellum. Subsequently, quantitative analysis revealed that, unlike tonic mode stimulation, burst mode stimulation appeared to be frequency-dependent., Conclusions: This study demonstrates the feasibility and safety of fMRI studies with simultaneous ONS in a subject with externalized electrodes. The activation and deactivation pattern induced by ONS depends on stimulation mode and frequency., (© 2010 International Neuromodulation Society.)