Effectiveness of combined dorsal root ganglion and spinal cord stimulation: a retrospective, single-centre case series for chronic focal neuropathic pain.

OBJECTIVE: This case series retrospectively reviewed the outcomes in patients implanted with combined, synchronous dorsal root ganglion stimulation (DRGS) and spinal cord stimulation (SCS) connected to a single implantable pulse generator (IPG) in a tertiary referral neuromodulation centre in the United Kingdom. METHODS: Twenty-six patients underwent a trial of DRGS+SCS for treating focal neuropathic pain between January 2016 and December 2019, with a follow-up in February 2022. A Transgrade approach was employed for DRGS. Patients were provided with 3 possible stimulation programs: DRGS-only, SCS-only, or DRGS+SCS. Patients were assessed for pain intensity, patients' global impression of change (PGIC), preferred lead(s) and complications. RESULTS: Twenty patients were successful and went on for full implantation. The most common diagnosis was Complex Regional Pain Syndrome. After an average of 3.1 years follow-up, 1 patient was lost to follow-up, and 2 were non-responders. Of the remaining 17 patients, 16 (94%) continued to report a PGIC of 7. The average pain intensity at Baseline was 8.5 on an NRS scale of 0-10. At the last follow-up, the average NRS reduction overall was 78.9% with no statistical difference between those preferring DRGS+SCS (n = 9), SCS-only (n = 3) and DRGS-only (n = 5). The combination of DRGS+SCS was preferred by 53% at the last follow-up. There were no serious neurological complications. CONCLUSIONS: This retrospective case series demonstrates the potential effectiveness of combined DRGS+SCS with sustained analgesia observed at an average follow-up of over 3 years. Implanting combined DRGS+SCS may provide programming flexibility and therapeutic alternatives.

A retrospective review of elevated lead impedances in impedance-dependent magnetic resonance-conditional spinal cord stimulation devices.

OBJECTIVES: Advances in Spinal cord stimulation (SCS) device technology in recent years have led to the development of SCS systems that are magnetic resonance imaging (MRI)-conditional, most of which are dependent on normal lead impedances. The objective of this study was to retrospectively analyze the rate of elevated lead impedance in these devices to determine the rate of failure of MR-conditional modes. MATERIALS AND METHODS: This was a single-center, retrospective, chart-based review conducted during a five-year period. Patients were included if they had been implanted with an impedance-dependent MR-conditional SCS and had a documented impedance check at least 6 months after implantation. A Kaplan-Meier survival analysis was performed to map the survival of MR-conditionality over time. RESULTS: There were 363 cases included between 2015 and 2020, which corresponded to a total of 602 SCS leads. Nevro was the most common manufacturer (67.8%), followed by Boston Scientific (22.3%) and Abbott (9.9%). The average overall follow-up time was 2.25 years. Overall, 67 (18.5%) of patients had lead impedances over 10,000 Ω at follow-up with a total of 186 electrode contacts (3.9%). Leads most commonly had either one (40%), two (22%) or three (12%) electrode contacts out of range. Risk of failure of lead impedances increased by 35.4% with each successive year to a peak of 43% of all leads by year 5. Mean overall survival time of normal lead impedances was 4.77 years (CI 4.40-5.13). There was no statistically significant difference in mean overall survival time between Abbott (M = 4.0 years, SD = 1.25), Boston Scientific (M = 4.64 years, SD = 1.75) and Nevro (M = 4.80 years, SD = 3.28), χ2 (2, N = 358) = 1.511, p = 0.47; however, Abbott leads had a greater total number of failed impedance contacts (50/568, 8.8%), in comparison to Nevro (124/3064, 4.0%), χ2 (1, N = 3630) = 23.76, p < 0.00001, at a similar follow-up time. CONCLUSION: This retrospective study identified elevated impedances in 18.5% of MR-conditional SCS devices at an average of 2.25 years follow-up resulting in loss of MR-conditionality and a mean overall lead survival time of 4.77 years for normal lead impedance.

Cascade Programming for 10 kHz Spinal Cord Stimulation: A Single Center Case Series of 114 Patients With Neuropathic Back and Leg Pain.

OBJECTIVE: Ten kilohertz spinal cord stimulation (SCS) is usually initiated in a single-bipolar configuration over the radiological reference point T9/T10 intervertebral disc space for neuropathic back and leg pain. Cascade is a duty-cycled, multi-bipolar contact configuration across an entire eight-contact lead. Potential advantages by using a broader area of SCS coverage include mitigation against minor lead migration and a reduction in the need for reprogramming. We report here the results of a retrospective case series of 114 patients using Cascade. MATERIALS AND METHODS: Retrospective data were collected over two years. We selected patients with neuropathic back with or without/leg pain who had a trial of SCS. Pain assessments using Numerical Rating Scales (NRS) and Patient Global Impression of Change (PGIC) scores were collected at baseline, six months, and last follow-up beyond 12 months (mean 15.1 months). Patients were programmed with 10 kHz SCS using Cascade during the trial, which was continued unless reporting inadequate pain relief. Morbidity and deviations from Cascade programming were also obtained. RESULTS: At six months, 87 of 97 (90.6%) patients with active devices were using Cascade and 58 of 72 (81%) patients at the last follow-up >12 months. There was a significant reduction in back NRS (8.3 vs. 3.9 [p < 0.0001], N = 97) and leg pain (7.53 vs. 3.83 [p < 0.0001], N = 77) at 6 months and last follow-up >12 months back (8.3 vs. 3.95 [p < 0.0001] N = 72), leg (7.53 vs. 3.534 [p < 0.0001], N = 58). The PGIC score was 6 of 7 or all of 7 in 72% of patients (70/97) at six months and in 68% (49/72) of patients at the last follow-up beyond 12 months. CONCLUSION: Cascade is an effective programming methodology that may have benefits over a single-bipole configuration for 10 kHz SCS, particularly during a trial of stimulation. Results from this study suggest it is a durable program for patients with neuropathic back and leg pain.

Can a psychologically based treatment help people to live with chronic pain when they are seeking a procedure to reduce it?

OBJECTIVE: At present, the potential benefits of psychologically oriented approaches to pain management for patients waiting to undergo medical interventions, such as neuromodulation, remain unclear. Therefore, this study aimed to examine the results of an interdisciplinary treatment based on principles of Acceptance and Commitment Therapy (ACT) delivered to a group of patients being considered for a neuromodulation procedure. DESIGN: Participants were 86 adults with chronic pain. All were referrals to a 2-week, interdisciplinary, residential pain management course for people being considered for a later neuromodulation procedure. Patients completed standard self-report measures of outcome and treatment process at the beginning and end of the 2-week treatment. Data on progression on the neuromodulation pathway were extracted from medical records. RESULTS: After the 2-week ACT-based interdisciplinary treatment, the majority of patients showed a clinically significant improvement on pain, depression, physical functioning, social functioning, and pain acceptance. Regression analyses indicated that change in pain acceptance related to improvements in depression, mental health, physical function, and social function. Results with regard to the trial of neuromodulation revealed that patients who did not proceed to the trial at their physician's request (n = 13) reported significantly worse depression and mental health, and lower levels of pain acceptance and committed action following the 2-week program compared with those who went for the trial. CONCLUSION: People seeking medical interventions to reduce pain appear able to benefit from an interdisciplinary treatment aimed to improve daily functioning and mental health through increased psychological flexibility.

The use of 10-kilohertz spinal cord stimulation in a cohort of patients with chronic neuropathic limb pain refractory to medical management.

OBJECTIVE: It is the purpose of this study to document our experience with the use of a 10-kHz high-frequency spinal cord stimulation (SCS) device for the relief of neuropathic pain of the upper and lower limbs. MATERIALS AND METHODS: A retrospective chart review was performed of all patients treated with the 10-kHz high-frequency SCS system for neuropathic pain (upper or lower limb) refractory to conventional treatment. All patients underwent a trial with one or two eight-contact percutaneous leads using 50-Hz traditional stimulation. If ≥ 80% paresthesia coverage of the painful area with traditional SCS was obtained, high-frequency 10-kHz SCS was used. Patients who had a significant reduction in pain score (≥ 50%) at the end of the trial received a permanent implant and were then followed for up to six months. Outcome measures included a numeric rating scale for pain, the Brief Pain Inventory, health-related quality of life (EQ-5D), the Pain Catastrophizing Scale, and patient satisfaction. RESULTS: Fifteen patients completed a trial of high-frequency 10-kHz SCS. Eleven patients proceeded to permanent implantation. Ten of the 11 patients who proceeded to full implantation had significant reductions in all of the collected outcome variables at one, three, and six months. CONCLUSIONS: In this small cohort of patients, high-frequency 10-kHz SCS reduced pain and improved quality of life. However, before we can conclude that high-frequency 10-kHz SCS for neuropathic pain of the upper and lower extremities is efficacious, a large-scale multicenter observational study should be performed to corroborate our small retrospective study.

Explant rates of electrical neuromodulation devices in 1177 patients in a single center over an 11-year period.

INTRODUCTION: The publication of explant rates has established risk factors and a definitive objective outcome of failure for spinal cord stimulation (SCS) treating neuropathic pain. We present a UK study analyzing explants of electrical neuromodulation devices for different conditions over 11 years in a single center specializing in neuromodulation. METHODS: A retrospective analysis was performed using a departmental database between 2008 and 2019. Explants were analyzed according to condition, mode of stimulation and other demographics using logistic regression and Kaplan-Meier graphs with log-rank (Mantel-Cox) test. RESULTS: Out of a total of 1177 patients, the explant rate was 17.8% at 5 years and 25.2% at 10 years. Loss of efficacy was the most frequent reason for explant 119/181 (65%). Multivariant regression analysis indicated patients with back pain without prior surgery had a reduced risk of explant (p=0.03). Patients with SCS systems that had 10 kHz, options of multiple waveforms, and rechargeable batteries also had a decreased risk of explant (p<0.001). None of these findings were confirmed when comparing Kaplan-Meier graphs, however. Contrary to other studies, we found gender and age were not independent variables for explant. CONCLUSION: These data contribute to a growing list of explant data in the scientific literature and give indications of what factors contribute to long-term utilization of electrical neuromodulation devices.

Constructive and deconstructive tool modification by chimpanzees (Pan troglodytes).

Nine chimpanzees (Pan troglodytes) were tested for their ability to assemble or disassemble the appropriate tool to obtain a food reward from two different apparatus. In its deconstructed form, the tool functioned as a probe for one apparatus. In its constructed form, the tool functioned as a hook, appropriate for a second apparatus. Each subject completed four test trials with each apparatus type. Tool types were randomized and counter-balanced between the two forms. Results demonstrated that adult and juvenile chimpanzees (N = 7) were successful with both tool types, while two infant chimpanzees performed near chance. Off-line video analyses revealed that tool modifications followed by attempted solutions by the adults and juveniles were typically correct on the first attempt. Neither infant was successful in modifying tools correctly on the first attempt over all eight trials. The older chimpanzees' ability to modify the appropriate tool consistently prior to use indicates an immediate recognition of the functional attributes necessary for the successful use of tool types on each apparatus, and represents a non-replication of a previously reported study by Povinelli.