A Temporary vs. Permanent Anchored Percutaneous Lead Trial of Spinal Cord Stimulation: A Comparison of Patient Outcomes and Adverse Events

Background: The use of magnetic resonance imaging (MRI) is continuously escalating for the evaluation of patients with persistent pain following lumbar spine surgery (LSS). Spinal cord stimulation (SCS) therapy is being clinically applied much more commonly for the management of chronic pain following LSS. There is an increased probability that these 2 incompatible modalities may be accidentally used in the same patient. Objectives: The purpose of this case report is to: (1) summarize a case in which a patient with a thoracic spinal cord stimulator underwent a diagnostic lumbar MRI, (2) describe the 3 magnetic fields used to generate images and their interactions with SCS devices, and (3) summarize the present literature. Study design: Case report. Setting: University hospital. Results: Aside from mild heat sensations in the generator/pocket site and very low intensity shocking sensations in the back while in the MRI scanner, the patient emerged from the study with no clinically detected adverse events. Subsequent activation of the SCS device would result in a brief intense shocking sensation. This persisted whenever the device was activated and required Implantable Pulse Generator (IPG) replacement. Electrical analysis revealed that some of the output circuitry switches, which regulate IPG stimulation and capacitor charge balancing, were damaged, most likely by MRI radiofrequency injected current. Limitations: Single case of a patient with a thoracic SCS having a lumbar MRI study. Conclusion: This case demonstrates the lack of compatibility of lumbar MRI and the Precision SCS system as well as one of the possible patient adverse events that can occur when patients are exposed to MRI outside of the approved device labeling. Key words: Spinal cord stimulation devices, magnetic resonance imaging

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Pedometry as an External Measure of Spinal Cord Stimulation Patient Outcomes

Neuromodulation Technology at the Neural Interface ◽

10.1111/ner.12377 ◽

2016 ◽

Vol 19 (5) ◽

pp. 482-486 ◽

Cited By ~ 5

Author(s):

Steven Lange ◽

Heather Smith ◽

Julia Prusik ◽

Christopher Fama ◽

Julie G. Pilitsis

Keyword(s):

Spinal Cord ◽

Patient Outcomes ◽

Spinal Cord Stimulation ◽

External Measure

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Patient Outcomes and Spinal Cord Stimulation: A Retrospective Case Series Evaluating Patient Satisfaction, Pain Scores, and Opioid Requirements

Pain Practice ◽

10.1111/papr.12340 ◽

2015 ◽

Vol 16 (7) ◽

pp. 899-904 ◽

Cited By ~ 23

Author(s):

Rebecca A. Sanders ◽

Susan M. Moeschler ◽

Halena M. Gazelka ◽

Tim J. Lamer ◽

Zhen Wang ◽

...

Keyword(s):

Spinal Cord ◽

Patient Satisfaction ◽

Patient Outcomes ◽

Spinal Cord Stimulation ◽

Case Series ◽

Retrospective Case ◽

Pain Scores ◽

Retrospective Case Series

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Sensor-Driven Position-Adaptive Spinal Cord Stimulation for Chronic Pain

January 2018 - Pain Physician ◽

10.36076/ppj.2012/15/1 ◽

2012 ◽

Vol 1;15 (1;1) ◽

pp. 1-12

Author(s):

David Schultz

Keyword(s):

Spinal Cord ◽

Pain Relief ◽

Adverse Events ◽

Spinal Cord Stimulation ◽

Rating Scale ◽

Body Position ◽

Primary Objective ◽

Position Sensing ◽

Manual Adjustment ◽

Patient Reported

Background: Variation in the intensity of neurostimulation due to body position is a practical problem for many patients implanted with spinal cord stimulation (SCS) systems because positional changes may result in overstimulation or understimulation that leads to frequent need for compensatory manual programming adjustments. Objectives: The purpose of this study was to assess the safety and effectiveness of a novel type of SCS therapy designed to automatically adapt stimulation amplitude in response to changes in a patient’s position or activity. The primary objective of the study was to demonstrate that automatic position-adaptive SCS benefited patients in terms of pain relief and/or convenience compared with neurostimulation adjusted with conventional manual programming. Secondary objectives included assessment of worsened pain relief with automatic adjustment; change in pain score; and the number of manual programming adjustments with position-adaptive neurostimulation compared with manual programming. Study Design: Prospective, multicenter, open-label, randomized crossover study. Setting: Ten interventional pain management centers in the US. Methods: Patients were enrolled a minimum of one week after a successful SCS screening trial. They were then implanted with the RestoreSensorTM neurostimulation device (Medtronic, Inc., Minneapolis, MN) that could be programmed to either automatic position-adaptive stimulation (AdaptiveStimTM) or manual adjustment of stimulation parameters. After implant, all devices were programmed to conventional manual adjustment for a 4-week postoperative period. The patients were then randomized to either conventional manual programming adjustment or position-adaptive stimulation with crossover to the opposite treatment arm occurring at 6 weeks after randomization. The patients were followed for another 6 weeks after crossover. This study was conducted under an FDA-approved Investigational Device Exemption (IDE) and approval of the responsible Institutional Review Boards (IRBs) of the study centers. Results: Seventy-nine patients were enrolled in the study. In an intent-to-treat analysis, 86.5% of patients achieved the primary objective of improved pain relief with no loss of convenience or improved convenience with no loss of pain relief using automatic position-adaptive stimulation compared with using conventional manual programming adjustment alone. This was statistically significantly greater than the predefined minimum success rate of 25%, P < 0.001 (exact one-sided 97.5% lower confidence limit was 76.5%). Only 2.8% of patients reported worsened pain relief during position-adaptive stimulation compared with manual programming. There was a statistically significant reduction in the mean numeric pain rating scale score compared with baseline scores in both treatment arms. Additionally, position-adaptive stimulation demonstrated a statistically significant 41% reduction in the daily average number of programming button presses for amplitude adjustment compared with manual programming (18.2 per day versus 30.7 per day, P = 0.002). Functional improvements reported with position-adaptive stimulation included: improved comfort during position changes (80.3%); improved activity (69%); and improved sleep (47.9%). Adverse events associated with uncomfortable sensations from stimulation did not differ significantly between treatment arms. The incidence of device-related serious adverse events was 3.9%. Limitations: Patients and physicians were not blinded to whether devices were programmed to automatic position-adaptive stimulation or manual adjustment. Responses to assessment questionnaires were based on patient recall. Conclusions: The study demonstrated that automatic position-adaptive stimulation is safe and effective in providing benefits in terms of patient-reported improved pain relief and convenience compared with using manual programming adjustment alone. Key words: spinal cord stimulation, neurostimulation, position sensing, physical activity accelerometer, neuromodulation, effectiveness, pain relief, position-adaptive stimulation, posture-adaptive stimulation, AdaptiveStim Clinical Trial: NCT01106404

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Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury

Frontiers in Rehabilitation Sciences ◽

10.3389/fresc.2021.740307 ◽

2022 ◽

Vol 2 ◽

Author(s):

Candace Tefertiller ◽

Meghan Rozwod ◽

Eric VandeGriend ◽

Patricia Bartelt ◽

Mitch Sevigny ◽

...

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Adverse Events ◽

Upper Extremity ◽

Spinal Cord Stimulation ◽

Walk Test ◽

Motor Score ◽

Outpatient Therapy ◽

Chronic Spinal Cord Injury ◽

Cord Injury

Objective: To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCSTSCS) on upper and lower extremity function in individuals with chronic spinal cord injury (SCI).Design: Prospective case series.Setting: SCI specific rehabilitation hospital.Participants: A convenience sample (N = 7) of individuals with tetraplegia who had previously been discharged from outpatient therapy due to a plateau in progress.Interventions: Individuals participated in 60 min of upper extremity (UE) functional task-specific practice (FTP) in combination with TSCS and 60 min of locomotor training in combination with TSCS 5x/week.Main Outcome Measures: The primary outcome for this analysis was the Capabilities of Upper Extremity Test (CUE-T). Secondary outcomes include UE motor score (UEMS), LE motor score (LEMS), sensation (light touch and pin prick), Nine-Hole Peg Test, 10 meter walk test, 6 min walk test, and 5 min stand test.Results: Seven individuals (four motor complete; three motor incomplete) completed 20–80 sessions UE and LE training augmented with TSCS and without any serious adverse events. Improvements were reported on the CUE-T in all seven individuals. Two individuals improved their ASIA impairment scale (AIS) classification (B to C; C to D) and two individuals improved their neurologic level of injury by one level (C4–C5; C5–C6). Sensation improved in five individuals and all four who started out with motor complete SCIs were able to voluntarily activate their LEs on command in the presence of stimulation.Conclusion: Individuals with chronic SCI who had previously demonstrated a plateau in function after an intensive outpatient therapy program were able to improve in a variety of UE and LE outcomes in response to TSCS without any adverse events. This was a small pilot study and future fully powered studies with comparative interventions need to be completed to assess efficacy.

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Feasibility and utility of transcutaneous spinal cord stimulation combined with walking-based therapy for people with motor incomplete spinal cord injury

Spinal Cord Series and Cases ◽

10.1038/s41394-020-00359-1 ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Liza V. McHugh ◽

Ashley A. Miller ◽

Kristan A. Leech ◽

Cynthia Salorio ◽

Rebecca H. Martin

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Adverse Events ◽

Spinal Cord Stimulation ◽

Walking Speed ◽

Minimal Detectable Change ◽

Walk Test ◽

Incomplete Spinal Cord Injury ◽

Cord Injury ◽

Transcutaneous Spinal Cord Stimulation

Abstract Study design Prospective case series. Objectives To evaluate the feasibility and preliminary efficacy of combining transcutaneous spinal cord stimulation (TSCS) with walking-based physical therapy. Setting Hospital-based outpatient center in Maryland, United States. Methods Ten individuals with chronic (>1 year) motor incomplete spinal cord injury (iSCI) completed 23 sessions of 2-h therapy over 8 weeks. TSCS was delivered for the first 30 min of each session using a clinically available device with adjustable current. To assess feasibility of the intervention, we tracked pain, adverse events, and participant retention. Preliminary efficacy was assessed by evaluating changes in walking speed, endurance, and quality following the intervention with select functional outcome measures (10-m walk test (10MWT), 6-min walk test (6MWT), timed up and go, and walking index for spinal cord injury II). Results We found that the combined intervention was feasible in an outpatient clinical setting. Participants tolerated the TSCS well, with no reports of significant adverse events or other issues (e.g., skin irritation or pain that disrupted training). None of the participants elected to discontinue the study. Participants also showed significant improvements in each measure of walking function following the intervention. Changes in walking speed, as measured by the 10MWT (0.56 ± 0.29 m/s to 0.72 ± 0.36 m/s), exceeded the minimal clinically important difference for individuals with iSCI. Changes in walking quality and endurance, as measured by the 6MWT (149.88 ± 99.87 m to 194.53 ± 106.56 m), exceeded the minimal detectable change for individuals with iSCI. Conclusions These results indicate that TSCS is clinically feasible and may be useful as an adjunct to walking-based therapy for adults with iSCI.

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Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact

Journal of Neurosurgery Spine ◽

10.3171/spi.2006.5.3.191 ◽

2006 ◽

Vol 5 (3) ◽

pp. 191-203 ◽

Cited By ~ 103

Author(s):

Krishna Kumar ◽

Jefferson R. Wilson ◽

Rod S. Taylor ◽

Shivani Gupta

Keyword(s):

Spinal Cord ◽

Adverse Events ◽

Success Rate ◽

Spinal Cord Stimulation ◽

Time Course ◽

Healthcare Resource ◽

Unit Cost ◽

Healthcare Budget ◽

The Cost

Object The long-term success of spinal cord stimulation is impeded by the high incidence of adverse events. The cost of complications to the healthcare budget is influenced by the time course needed to reverse the effect, and by the type of corrective measures required. Understanding the mechanism of complications and reducing them can improve the overall success rate and the cost factor. Methods The authors performed a retrospective analysis of data obtained in 160 patients treated during a 10-year period. For each category of complication, the level of healthcare resource use was assessed for each case and a unit cost was applied. The total cost of each complication was determined by summing across healthcare resource headings. All cost calculations were performed in Canadian dollars at 2005 prices. To understand the mechanics of various hardware-related complications and how to avoid them, the authors have utilized the results of bench tests conducted at Medtronic, Inc. Fifty-one adverse events occurred in 42 of the 160 patients. The complications were classified as either hardware related (39 events) or biological (12 events). The mean cost of complications during the 10-year study period was $7092 (range $130–$22,406). Conclusions Complications not only disrupt the effect of pain control but also pose an added expense to the already high cost of therapy. It is possible to reduce the complication rate, and thus improve the long-term success rate, by following the suggestions made in this paper, which are supported by the biomechanics of the human body and the implanted material.

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