Mimicking the brain: evaluation of St Jude Medical’s Prodigy Chronic Pain System with Burst Technology

Abstract

The Prodigy is a new type of internal pulse generator that controls the delivery of electrical stimuli to nervous tissue. It is capable of delivering burst stimulation, which is a novel waveform that consists of closely spaced high-frequency electrical impulses delivered in packets riding on a plateau, and followed by a quiescent period. Its inception was based on mimicking burst firing in the nervous system and usually delivered by unmyelinated fibers that uniformly have a motivational affective homeostatic function. It thereby targets a multimodal salience network, even though the stimuli are delivered at the level of the spinal cord. As such, it is specifically capable of influencing the affective/attentional components of pain. Burst stimulation was initially safely applied off-label to the auditory cortex for tinnitus, and later also to the spinal cord, the somatosensory cortex for neuropathic pain, subcutaneously for failed back surgery syndrome, and cingulate cortex for addiction and tinnitus.

Burst Spinal Cord Stimulation Increases Peripheral Antineuroinflammatory Interleukin 10 Levels in Failed Back Surgery Syndrome Patients With Predominant Back Pain

“…Furthermore, we found a correlation between IL‐10 changes and Burst SCS responsiveness for back pain and sleep quality. The observations made in this study were in line with those of the previous published data related to Burst SCS outcome in back pain .…”

Spinal Cord Stimulation: Clinical Efficacy and Potential Mechanisms

“…Most patients (68%) preferred burst stimulation, and the majority who received burst SCS did not feel paresthesias, consistent with previous reports. There were no differences between burst and tonic stimulation for function and psychosocial assessments, which was surprising given that burst is hypothesized to mediate pain relief by activating medial pathways and normalizing affective/attentional components of pain . These results replicated findings of previous smaller studies, although the observed difference in pain scores was somewhat less than what others reported .…”

Burst and Tonic Spinal Cord Stimulation: Different and Common Brain Mechanisms

“…The burst stimulation adds by also modulating the medial pain pathway, possibly by a direct modulation of the spinothalamic pathways as indirectly suggested by animal research. This normalizes an imbalance between ascending pain input via the medial system and descending pain inhibitory activity which could explain the superior results described by burst SCS in comparison with tonic stimulation . Further functional imaging studies should be performed, evaluating these findings on a larger sample and with other techniques.…”

“…It has furthermore been suggested that burst firing is involved in rerouting information , permitting parallel processing, and is involved in synchronizing network activity . Copying burst firing in an electronic version might capture some of these characteristics, which could be beneficial as a stimulation design . As mentioned for SCS, the patient's internal pulse generator is routinely programmed at 40 Hz burst mode with 500 Hz spike mode, using spikes at 1000 μsec pulse width , similar to what was used for subcutaneous C2 nerve field stimulation for FBSS .…”