scholarly journals Automatic Adaptation of Neurostimulation Therapy in Response to Changes in Patient Position: Results of the Posture Responsive Spinal Cord Stimulation (PRS) Research Study

2011 ◽  
Vol 5;14 (5;9) ◽  
pp. 407-417
Author(s):  
Cristy M. Schade
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Body Position ◽  
Leg Pain ◽  
Test Protocol ◽  
Automatic Adjustment ◽  
Patient Position ◽  
Manual Adjustment ◽  
Stimulation System ◽  
Stimulation Amplitude

Background: Variation in the intensity of neurostimulation with body position is a practical problem for many patients implanted with a spinal cord stimulation system because positional changes may result in overstimulation or understimulation. These posture-related changes in patients’ perception of paresthesia can affect therapeutic outcomes of spinal cord stimulation therapy. An accelerometer-based algorithm that automatically adjusts spinal cord stimulation based on sensed body position or activity represents a potential solution to the problem of position-mediated variations in paresthesia perception. Objective: The objective of this study was to compare patient satisfaction ratings for manual versus automatic adjustment of spinal cord stimulation amplitude in response to positional changes. Study Design: Prospective, multicenter, open-label, randomized trial Setting: 2 pain centers in the US. Method: Twenty patients at 2 centers in the U.S. who had been implanted with a spinal cord stimulation system for low back and/or leg pain were enrolled in the study. During a 3-day run-in phase, patient position and activity changes were monitored with an ambulatory data recorder and with a research patient programmer which recorded all stimulation parameter changes. Patients who made ≥ 2 amplitude adjustments per 24- hour period were invited to participate in an in-clinic phase. During the in-clinic phase, patients’ preferred stimulation amplitude and therapy impedance measured at the preferred stimulation amplitude were determined as they performed a series of 8 physical tasks. Satisfaction ratings were determined during position transitions between the physical tasks using both manual and automatic adjustments. Results: Among the 15 patients who completed the in-clinic test protocol, overall satisfaction ratings were significantly higher for automatic adjustment of stimulation amplitudes versus manual adjustments. Patients reported statistically significant improvements with automatic versus manual adjustment for the standing to supine transition and for supine to standing transition. Approximately 74% of participants rated the paresthesia intensity of the automatic adjustment algorithm as “just right” for the physical tasks that were completed. Limitations: Small study size. Conclusion: Patients preferred automatic versus manual adjustment of stimulation amplitude in response to changes in paresthesia consequent to positional changes during in-clinic testing. Key words: spinal cord stimulation, automaticity, paresthesia, neuromodulation, neurostimulation, adaptive stimulation, posture responsive stimulation, accelerometry

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

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

scholarly journals Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT

2018 ◽  
Vol 27 (8) ◽  
pp. 2035-2044 ◽  
Author(s):  
Kasra Amirdelfan ◽  
Cong Yu ◽  
Matthew W. Doust ◽  
Bradford E. Gliner ◽  
Donna M. Morgan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Leg Pain ◽  
Life Improvement ◽  
Pain Patients

scholarly journals High-Frequency Spinal Cord Stimulation at T9/10 in Patients With Failed Back Surgery Syndrome

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Naoki Higashiyama ◽  
Takuro Endo ◽  
Taku Sugawara
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Low Frequency ◽  
The Elderly ◽  
Failed Back Surgery Syndrome ◽  
Leg Pain ◽  
Effective Treatment Option ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract INTRODUCTION Spinal cord stimulation (SCS) is an effective treatment option for low back pain and radicular leg pain of failed back surgery syndrome (FBSS). In a recent study, high-frequency spinal cord stimulation (HFSCS) was found to be more effective in treating chronic pain than traditional paresthesia-based low-frequency SCS (paresthesia SCS). The purpose of this study is to evaluate the efficacy of paresthesia SCS and HFSCS in improving outcomes. METHODS We retrospectively reviewed the outcomes of patients who underwent paresthesia SCS or HFSCS between September 2016 and January 2019. Paresthesia SCS is generally characterized by programming stimulation parameters such that the patient experiences paresthesia, and the paresthesia topography overlaps the pain topography as much as possible. The patient in HFSCS had a placement of cylindrical lead at levels T9-10. Patients were programmed with the electrode overlying the inferior endplate of T9 (+) and the electrode overlying the superior endplate of T10 (–). RESULTS A total of 14 patients (4 males, 10 females) underwent paresthesia SCS implantation. Mean age was 77.2 ± 9.6 yr. A total of 5 patients (2 males, 3 females) underwent HFSCS implantation. Mean age was 78.2 ± 7.5 yr. Operative time was shorter for the HFSCS group compared to the paresthesia SCS group (53.4 ± 4.8 min vs 82.9 ± 20.3 min, respectively; P < .001). A total of 5 out of 5 patients in the HFSCS group (100%) and 10 out of 14 patients in the paresthesia SCS group (71.4%) achieved the outcome of 50% pain relief (P = .25) CONCLUSION To confirm paresthesia during the procedure in the elderly may be complicated by hearing/language difficulties or by sedative-related confusion. Compared to paresthesia SCS, HFSCS allows for lower operative times and a more efficient and accurate positioning of the electrodes.

scholarly journals High-frequency 10 kHz Spinal Cord Stimulation for Chronic Back and Leg Pain

2020 ◽  
Vol 36 (11) ◽  
pp. 852-861
Author(s):  
Rod S. Taylor ◽  
Anthony Bentley ◽  
Bruce Campbell ◽  
Kieran Murphy
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Leg Pain
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