Dorsal root ganglion stimulation approval by the Food and Drug Administration: advice on evolving the process

Deer, Timothy R.; Pope, Jason E.

doi:10.1080/14737175.2016.1206817

Cited by 26 publications

(17 citation statements)

References 12 publications

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“…Dorsal root ganglion stimulation (DRGS) was approved by the U.S. Food and Drug Administration in early 2016 for the treatment of intractable complex regional pain syndrome in the lower limbs (8, 9), and has shown success at treating several other focal pain indications (e.g., phantom limb pain, painful diabetic neuropathy, groin pain) (10–12). In contrast to SCS, DRGS electrodes are placed in the intraforaminal space, where they apply electrical stimulation to a single DRG.…”

Section: Introductionmentioning

confidence: 99%

The Effect of Clinically Controllable Factors on Neural Activation During Dorsal Root Ganglion Stimulation

Graham

Bruns

Duan

et al. 2021

Neuromodulation: Technology at the Neural Interface

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Objective Dorsal root ganglion stimulation (DRGS) is an effective therapy for chronic pain, though its mechanisms of action are unknown. Currently, we do not understand how clinically controllable parameters (e.g., electrode position, stimulus pulse width) affect the direct neural response to DRGS. Therefore, the goal of this study was to utilize a computational modeling approach to characterize how varying clinically controllable parameters changed neural activation profiles during DRGS. Materials and Methods We coupled a finite element model of a human L5 DRG to multicompartment models of primary sensory neurons (i.e., Aα‐, Aβ‐, Aδ‐, and C‐neurons). We calculated the stimulation amplitudes necessary to elicit one or more action potentials in each neuron, and examined how neural activation profiles were affected by varying clinically controllable parameters. Results In general, DRGS predominantly activated large myelinated Aα‐ and Aβ‐neurons. Shifting the electrode more than 2 mm away from the ganglion abolished most DRGS‐induced neural activation. Increasing the stimulus pulse width to 500 μs or greater increased the number of activated Aδ‐neurons, while shorter pulse widths typically only activated Aα‐ and Aβ‐neurons. Placing a cathode near a nerve root, or an anode near the ganglion body, maximized Aβ‐mechanoreceptor activation. Guarded active contact configurations did not activate more Aβ‐mechanoreceptors than conventional bipolar configurations. Conclusions Our results suggest that DRGS applied with stimulation parameters within typical clinical ranges predominantly activates Aβ‐mechanoreceptors. In general, varying clinically controllable parameters affects the number of Aβ‐mechanoreceptors activated, although longer pulse widths can increase Aδ‐neuron activation. Our data support several Neuromodulation Appropriateness Consensus Committee guidelines on the clinical implementation of DRGS.

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Section: Introductionmentioning

confidence: 99%

The Effect of Clinically Controllable Factors on Neural Activation During Dorsal Root Ganglion Stimulation

Graham

Bruns

Duan

et al. 2021

Neuromodulation: Technology at the Neural Interface

View full text Add to dashboard Cite

show abstract

“…In this intervention, leads are placed adjacent to the DRG in the vertebral foramen. DRG‐S is currently only FDA‐approved for the treatment of complex regional pain syndrome (10, 11). However, DRG‐S is also effective for back pain, and a number of published “off‐label” cohorts have included back pain cases (12–14).…”

Section: Introductionmentioning

confidence: 99%

The Pathways and Processes Underlying Spinal Transmission of Low Back Pain: Observations From Dorsal Root Ganglion Stimulation Treatment

Chapman

Groenen

Vissers

et al. 2021

Neuromodulation: Technology at the Neural Interface

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“…Compared with spinal cord stimulation (SCS) leads, these DRG specific leads contain a smaller cross sectional area, contact size, intercontact spacing, less rigidity and are implanted via a unique contralateral technique. 34 Although the DRG stimulator received US Food and Drug Administration (FDA) approval only recently, the device has been available in Europe and Australia since receiving regulatory Conformité Européene (CE) Mark approval in late 2011. 56…”

Section: Introductionmentioning

confidence: 99%

Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database

Sivanesan

Bicket

Cohen

2019

Regional Anesthesia &Amp; Pain Medicine

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Background and objectivesDorsal root ganglion stimulation is an emerging therapy in the treatment of chronic pain. Compared with traditional spinal cord stimulation, it allows a discretely targeted stimulation profile and may act via differing mechanisms of action. Despite these advantages, little is known about the complications associated with this new modality.MethodsWe queried the MAUDE (Manufacturer and User Facility Device Experience) database for all entries named ‘Dorsal root ganglion stimulator for pain relief’ reported between May 1, 2016 and December 31, 2017. We verified these data through the Office of the Freedom of Information Act at the US Food and Drug Administration. We then eliminated duplicate entries and categorized each complication based on the event description. A secondary analysis was performed to characterize the serious adverse events and the severity of new neurologic symptoms and infections.ResultsWe identified 979 unique episodes following our process of deduplication. Almost half (47%) of entries were categorized as device-related complications, a quarter (28%) as procedural complications, with the remainder as patient complaints (12%), serious adverse events (2.4%), and ‘other’ complications (4.6%). The majority of complications were managed surgically with revision (n = 488; 49.8%) rather than explant (n = 161; 16.4%) events, respectively.ConclusionsThe ‘Dorsal root ganglion stimulator for pain relief’ device has been publicized as a breakthrough in neuromodulation technologies. As with any new technology, we must proceed with caution and re-evaluate effectiveness as information becomes available. The MAUDE database has provided safety data unique for this device that will aid in informed consent and further refinement of this innovative therapy.

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Dorsal root ganglion stimulation approval by the Food and Drug Administration: advice on evolving the process

Cited by 26 publications

References 12 publications

The Effect of Clinically Controllable Factors on Neural Activation During Dorsal Root Ganglion Stimulation

The Effect of Clinically Controllable Factors on Neural Activation During Dorsal Root Ganglion Stimulation

The Pathways and Processes Underlying Spinal Transmission of Low Back Pain: Observations From Dorsal Root Ganglion Stimulation Treatment

Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database

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