Response to Letter to the Editor Regarding “Complications and Effects of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Neuropathic Pain: A Nationwide Cohort Study in Denmark”

Horan, Mattias; Blichfeldt-Eckhardt, Morten Rune

doi:10.1111/ner.13269

Cited by 6 publications

(3 citation statements)

References 5 publications

(4 reference statements)

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“…The predominance of lead-related AEs is comparable with the findings of an observational multicentre cohort study, which reported that 13 of 33 patients (39%) who were implanted with FDA-approved DRGS systems required revisions for lead defects. 12 Although it has been suggested that the high rate of lead-related revisions is related to an earlier “ball tip” lead design that has since been replaced by a “slim tip,” 11,17 both types of lead were used during this study (Fig. 5).…”

Section: Discussionmentioning

confidence: 99%

A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain

Eldabe

Copley

Gulve

et al. 2021

Pain

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Initial clinical studies have shown that the stimulation of the dorsal root ganglion (DRG) can significantly reduce chronic intractable pain. However, clinical data on long-term results and complications of these systems are limited. The aim of this prospective study is to report on a single center long-term follow-up of DRG stimulation for intractable chronic pain. Participants were implanted with DRG stimulation devices between 2013 and 2015 with an observation period of 24 months. Patients were contacted again in 2020 for a final follow-up (ie, between 5 and 7 years postimplantation). Forty-two participants were recruited, of whom 32 received the fully implantable pulse generator (IPG). At the final follow-up, 50% (16/32) of participants were still using DRG stimulation. Two participants still had the original IPG and 14 had received a replacement IPG. Pain scores were significantly reduced at 24 months, mean difference 1.7 (95% confidence interval: 0.2-3.3, P 5 0.03), and at the last follow-up, mean difference 2.1 (95% confidence interval: 0.3-4, P 5 0.03). Significant improvements were observed for health-related quality of life. The findings were generally robust to imputation methods of missing data. Implantable pulse generators of 8 patients were explanted because of dissatisfaction with pain relief. In conclusion, DRG stimulation can provide effective pain relief and improved quality of life in patients suffering with neuropathic pain, although this study had a revision rate of 42% within the first 24 months, and 56% of IPGs that were replaced because of battery depletion had a shorter than expected battery life.

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Section: Discussionmentioning

confidence: 99%

A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain

Eldabe

Copley

Gulve

et al. 2021

Pain

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“…This process can be uncomfortable for patients, and permanent implants often require the use of general anesthesia. Additionally, recent clinical reports have shown significant DRG lead migration at the sacral level when using a transforaminal approach [19,20], and several studies have reported other complications, such as pain near the implantable pulse generator (IPG) and lead fracture [21][22][23], resulting in some countries pausing DRGS implantations. Thus, to achieve improved clinical implementation and to reduce complexity to minimize the failure points, a minimally invasive procedure is needed to deliver effective stimulation without the drawbacks of existing electrode technologies and their placement procedures.…”

Section: Introductionmentioning

confidence: 99%

Computational modeling of dorsal root ganglion stimulation using an Injectrode

Bhowmick,

Graham,

Verma

et al. 2024

J. Neural Eng.

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Objective. Minimally invasive neuromodulation therapies like the Injectrode, which is composed of a tightly wound polymer-coated platinum/iridium microcoil, offer a low-risk approach for administering electrical stimulation to the dorsal root ganglion (DRG). This flexible electrode is aimed to conform to the DRG. The stimulation occurs through a transcutaneous electrical stimulation (TES) patch, which subsequently transmits the stimulation to the Injectrode via a subcutaneous metal collector. However, effectiveness of stimulation relies on the specific geometrical configurations of the Injectrode-collector-patch system. Hence, there is a need to investigate which design parameters influence the activation of targeted neural structures.Approach. We employed a hybrid computational modeling approach to analyze the impact of the Injectrode system design parameters on charge delivery and the neural response to stimulation. We constructed multiple finite element method models of DRG stimulation and multi-compartment models of DRG neurons. We simulated the neural responses using parameters based on prior acute preclinical experiments. Additionally, we developed multiple human-scale computational models of DRG stimulation to investigate how design parameters like Injectrode size and orientation influenced neural activation thresholds.Main results. Our findings were in accordance with acute experimental measurements and indicated that the Injectrode system predominantly engages large-diameter afferents (Aβ-fibers). These activation thresholds were contingent upon the surface area of the Injectrode. As the charge density decreased due to increasing surface area, there was a corresponding expansion in the stimulation amplitude range before triggering any pain-related mechanoreceptor (Aδ-fibers) activity.Significance. The Injectrode demonstrates potential as a viable technology for minimally invasive stimulation of the DRG. Our findings indicate that utilizing a larger surface area Injectrode enhances the therapeutic margin, effectively distinguishing the desired Aβ activation from the undesired Aδ-fiber activation.

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“…There has also been much debate surrounding the complication rates and adverse events related to DRG stimulation. While a recent report suggested DRG stimulation has an excellent safety record , several studies have reported adverse events, such as pain near the site of the implantable pulse generator (IPG) and lead fracture (Deer et al 2017, Horan et al 2020, Huygen et al 2020. Some experts believe that the complications are due to the increased time and learning curve required for performing the DRG stimulation lead implant procedure, as well as the recency of its clinical implementation (Lubenow and Nijhuis 2020).…”

Section: Introductionmentioning

confidence: 99%

Stimulation of the dorsal root ganglion using an Injectrode^®

et al. 2021

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Objective. The goal of this work was to compare afferent fiber recruitment by dorsal root ganglion (DRG) stimulation using an injectable polymer electrode (Injectrode®) and a more traditional cylindrical metal electrode. Approach. We exposed the L6 and L7 DRG in four cats via a partial laminectomy or burr hole. We stimulated the DRG using an Injectrode or a stainless steel (SS) electrode using biphasic pulses at three different pulse widths (80, 150, 300 μs) and pulse amplitudes spanning the range used for clinical DRG stimulation. We recorded antidromic evoked compound action potentials (ECAPs) in the sciatic, tibial, and common peroneal nerves using nerve cuffs. We calculated the conduction velocity of the ECAPs and determined the charge-thresholds and recruitment rates for ECAPs from Aα, Aβ, and Aδ fibers. We also performed electrochemical impedance spectroscopy measurements for both electrode types. Main results. The ECAP thresholds for the Injectrode did not differ from the SS electrode across all primary afferents (Aα, Aβ, Aδ) and pulse widths; charge-thresholds increased with wider pulse widths. Thresholds for generating ECAPs from Aβ fibers were 100.0 ± 32.3 nC using the SS electrode, and 90.9 ± 42.9 nC using the Injectrode. The ECAP thresholds from the Injectrode were consistent over several hours of stimulation. The rate of recruitment was similar between the Injectrodes and SS electrode and decreased with wider pulse widths. Significance. The Injectrode can effectively excite primary afferents when used for DRG stimulation within the range of parameters used for clinical DRG stimulation. The Injectrode can be implanted through minimally invasive techniques while achieving similar neural activation to conventional electrodes, making it an excellent candidate for future DRG stimulation and neuroprosthetic applications.

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Response to Letter to the Editor Regarding “Complications and Effects of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Neuropathic Pain: A Nationwide Cohort Study in Denmark”

Cited by 6 publications

References 5 publications

A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain

A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain

Computational modeling of dorsal root ganglion stimulation using an Injectrode

Stimulation of the dorsal root ganglion using an Injectrode^®

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Response to Letter to the Editor Regarding “Complications and Effects of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Neuropathic Pain: A Nationwide Cohort Study in Denmark”

Cited by 6 publications

References 5 publications

A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain

A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain

Computational modeling of dorsal root ganglion stimulation using an Injectrode

Stimulation of the dorsal root ganglion using an Injectrode®

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Product

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Stimulation of the dorsal root ganglion using an Injectrode^®