Synopsis

Surgical interventions may be performed to treat Lumbar Spinal Stenosis (LSS) once conservative treatment options are exhausted. However, decompression surgery with or without fusion may result in loss of physiologic lumbar lordosis which may further lead to sagittal imbalance of the spine. Radiographs collected from patients, who participated in a previously completed randomized controlled trial of an indirect decompression system, were assessed and Lumbar Lordosis (LL) angle (as measured from the superior end plate of L1 to the end plate of S1) was calculated.¹ No change in global lordosis angle was noted up to 5-years post-procedure.

Disclosures

• Study Sponsored by Boston Scientific. 
• Consulting Agreement with Boston Scientific: Drs. Naidu and Mehta. 
• Employees of Boston Scientific: Holly Kaufman, Lilly Chen, Roshini Jain

Synopsis

Cycling of Spinal Cord Stimulation (SCS)-based neurostimulation may prevent the development of neural tolerance and enable greater control of the dose of electrical energy delivered to neural tissues.^{1, 2} Fast-Acting Sub-Perception Therapy (FAST) is a novel SCS-based approach that can provide pain relief within minutes of initial activation without need for paresthesia in order to achieve clinically-meaningful analgesia.³ In this clinical evaluation, SCS-implanted patients using FAST underwent various cycling settings and reported their overall pain scores, sleep quality, and preference. With use of FAST-based cycling (50% or 25% duty cycle), lower energy consumption and equivalent pain relief was noted.

Disclosures

• Study Sponsored by Boston Scientific. 
• Consulting Agreement with Boston Scientific: Drs. North, Ferro, Leier, Newton and Wilson. 
• Employees of Boston Scientific: Lilly Chen and Roshini Jain

Synopsis

Surgical interventions may be performed to treat Lumbar Spinal Stenosis (LSS) once conservative treatment options are exhausted. However, decompression surgery with or without fusion may result in loss of physiologic lumbar lordosis which may further lead to sagittal imbalance of the spine. Radiographs collected from patients, who participated in a previously completed randomized controlled trial of an indirect decompression system, were assessed and Lumbar Lordosis (LL) angle (as measured from the superior end plate of L1 to the end plate of S1) was calculated. No change in global lordosis angle was noted up to 5-years post-procedure.

Disclosures

• Study Sponsored by Boston Scientific. 
• Consulting Agreement with Boston Scientific: Drs. Whang and Antony 
• Employees of Boston Scientific: Lilly Chen and Roshini Jain

Synopsis

Effective leg pain responder rate and pain severity have been previously demonstrated In patients implanted with an Interspinous Spacer out to 12-months post-operation. This is a consecutive, multi-center, case-series based on retrospective chart review as part of an on-going, real­-world evaluation of Indirect Decompression Systems (IDS) outcomes for lumbar spinal stenosis. Patients reported a mean NRS pain score 9.4 ± 0.5 prior to IDS implant, and a 5.4-point improvement (p<0.0001, n = 41) was reported at last follow-up (mean = 115 days). The preliminary evidence derived from this on-going, real-world observational case-series aligns so far with other published reports.

Disclosures

• Study Sponsored by Boston Scientific. 
• Consulting Agreement with Boston Scientific: Drs. Esposito, Ferro, Wilson, Hatheway, Moore, and Jameson. 
• Employees of Boston Scientific: Holly Kaufman, Lilly Chen and Roshini Jain

Synopsis

This systematic review and meta-analysis aims to determine the rate of patient satisfaction with the use of SCS and DRG-S in the treatment of chronic intractable pain. We queried articles from multiple electronic data bases, including MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials data bases, and hand-searched reference lists of identified publications. Our search strategy identified 242 unique citations, of which nine RCTs and 23 observational studies were included for analysis. Overall, 25 studies comprising 1355 participants were pooled in our quantitative analysis. The pooled proportion of patients who self-reported satisfaction from all studies was 82.2% (95% CI, 77.8%-86.2%). Our results show high levels of patient satisfaction across the SCS and DRG-S literature when these treatment modalities are used for chronic intractable pain. However, there is a scarcity of unbiased and/or non-industry-funded prospective studies in the neuromodulation field, and future efforts to expand this area of the SCS and DRG-S literature are greatly needed.

Disclosures

Nothing to Disclose by Any Author

Synopsis

Differential Target Multiplexed^TM spinal cord stimulation (SCS) is an established therapy that has shown superior back pain relief to traditional SCS.1 This study evaluates efficacy, device longevity, and recharge requirements of a reduced DTMTM derivative in patients with severe back and leg pain to understand opportunities to tailor therapy based on patient profiles and estimate device longevity and recharge requirements. Subjects were trialed with the DTMTM derivative and those who reported ≥50% improvement in overall pain were eligible for implant. Implanted subjects have reported therapy satisfaction and improved quality of life through 3-months and sustained overall pain relief through 6-months.

Disclosures

This study was funded by Medtronic.
K. Amirdelfan reports SAB at Nevro, Medtronic, and Nalu, consulting fees from Biotronik, Nalu, Nevro, Saluda, and Medtronic, research grants to institution from Nevro, Biotronik, and reports minor options at Nalu; M. Esposito reports SAB and consulting fees from Abbott, Biotronik, Boston Scientific, Flowonix, Inspan, Medtronic, Nevro, and Stimwave; M. Fishman reports research grants to institution from Abbott, Biotronik, Boston Scientific, Medtronic, Nalu Medical, SGX Medical, and Thermaquil, consulting fees from Abbott, Biotronik, Medtronic, and Nevro, faculty appointment with Abbott and Medtronic, and stock/stock options at Celeri Health, and Thermaquil; K. Gatzinsky reports consultancy (Teaching/training) at Medtronic, Boston Scientific, Abbott, Nevro, and SAB at Medtronic and Boston Scientific;. P.K. Grewal reports SAB at Medtronic; R. Justiz reports consulting fees from Medtronic; J.W. Kallewaard reports SAB at Abbott, Medtronic, Saluda and Boston Scientific; D. Provenzano reports consulting fees from Avanos, Boston Scientific, Medtronic, Nevro, SI Bone, and Wise, and research grants to institution from Avanos, Boston Scientific, Medtronic, Nevro, Stimgenics, and Abbott; T. White reports consulting fees from Medtronic; T. Bromberg reports relationships with Medtronic and Saluda; A. Calodney reports relationships with Boston Scientific, Medtronic, Nevro, and PainTeq; T. Schmidt reports relationships with Boston Scientific and Medtronic; J. Peacock and B. Shah report nothing to disclose; L. Davies, K. Noel, A. Cleland, M. LaRue, and C. Porritt are all employees of Medtronic.

Synopsis

Post dural puncture headaches are, more recently, being documented as a complication related to spinal cord stimulator placement. Dural compromise are usually appreciated prior to this condition's onset. A viable treatment for post dural headaches is epidural blood patches. Less reported in literature still, is the presence of post dural headache after leads removal from a trail spinal cord stimulator, when initial placement of the spinal cord stimulator was without noted dural compromise and tolerated by the patient well prior to its removal.  

Disclosures

Nothing to Disclose by any Author

Synopsis

In order to overcome barriers to adoption of neurostimulation technologies by patients and clinicians, we present here a minimally invasive needle placeable and fully implanted neurostimulator that is suitable for clinical imaging (U/S, X-Ray, MRI). The structural design and placement procedure of the injectable helical wire structure electrode (Injectrode) renders the device self anchoring and deliverable using a minimal number of components. Demonstrated are placements by clinicians on various nerve targets in animal and human models.

Disclosures

• Stephan Nieuwoudt is employed by and owns equity in Neuronoff, Inc. 
• Amelia Howe is employed by and owns equity in Neuronoff, Inc. 
• Johanna Pearson is employed by Neuronoff, Inc. 
• Emily Szabo is employed by and owns equity in Neuronoff, Inc. 
• Morgan McGaughey is employed by and owns equity in Neuronoff, Inc. 
• Derrick Liu is employed by and owns equity in Neuronoff, Inc. 
• Shaher Ahmad is employed by and owns equity in Neuronoff, Inc. 
• Kip A. Ludwig is receiving funds from and owns equity in Neuronoff, Inc.
• Hesham Elsharkawy owns equity in Neuronoff, Inc. 
• Amol Soin owns equity in Neuronoff, Inc. 
• Alaa Abd-Elsayed owns equity in Neuronoff, Inc. 
• Manfred Franke is employed by and owns equity in Neuronoff, Inc. 
• Andrew J. Shoffstall is receiving funds from and owns equity in Neuronoff, Inc.
• This project is supported by Neuronoff Inc., NIH 1U18EB029251-01 Grant, and the DARPA EEI program. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense or the National Institutes of Health.

Synopsis

Here we propose a characterization of Fibromyalgia pathophysiology in gray matter (GM) tissue using a multimodal neuroimaging approach (volumetric, diffusion-weighted, and resting-state functional connectivity).

Disclosures

Nothing to Disclose by any Author

Synopsis

Evoked compound action potentials (ECAPs) from both the dorsal columns and the anterolateral system (ALS) in sheep were used to quantify neural activation with burst and conventional spinal cord stimulation (SCS). When dosed equivalently, no statistically significant difference in neural activation was noted between both stimulation modalities. Sub-threshold SCS resulted in no change in neural activation, while supra-threshold SCS potentiated ALS excitability in an equivalent manner for both modalities. We postulate that differences noted previously between burst and conventional SCS results from non-equivalent dosing between these stimulation modalities.

Disclosures

• Authors Dinsmoor and Usoro are employees of Medtronic plc. 
• Author Poree has stock options in Nalu, and has received research funding from Abbott, Nalu, and Saluda; he is a consultant for Nalu, Saluda, and Medtronic. 
• This work was funded by Medtronic plc.