Spinal cord stimulation (SCS) is a drug-free treatment for chronic neuropathic pain. Recent SCS technology can record evoked compound action potentials (ECAPs) in the spinal cord during therapy and utilize features of the sensed ECAP to optimize the SCS. The purpose of this work is to characterize the relevant parameters that govern the integrity and morphology of acquired ECAPs, and the implications for pain management clinicians and researchers working with ECAPs. Materials and Methods: Eight-contact percutaneous SCS leads were implanted into sheep, and a prototype ECAP-sensing system was used to record spinal cord activity across a range of electrode configurations, pulse widths, and stimulus amplitudes. Similar iterative testing was then completed in human subjects who were undergoing trials of commercial SCS systems. Results: Longer pulse width stimulation results in a progressive increase in ECAP latency, a neurophysiologic effect that enables ECAP sensing with longer pulses despite more encroachment by stimulation artifact. ECAPs may manifest a polyphasic morphology-an effect not seen in all subjects studied-with longer pulse width stimulation; these later phases may be used to assess ECAP amplitude when earlier features are effaced by artifact. Triphasic stimulation limits artifact from spinal cord ECAPs at the expense of potentially higher activation thresholds. If applied, alternating polarity stimulation must account for the ECAP latency differences resulting from alternating sites of neural activation. Conclusion: Together, this information can allow the ECAP to be readily distinguished from the stimulation artifact, although movement may continue to be a confounder; caution is inculcated for ECAP signal processing techniques that rely on the stability of the artifact to avoid clinically misleading results. The promise of closed-loop, ECAP-servoed neuromodulation relies on accurate and proper sensing of the ECAP, while clearly elucidating the clinically relevant trade-offs and design choices made to enable these novel features.

ObjectivesSpinal cord stimulation (SCS) is a drug free treatment for chronic pain. Recent technological advances have enabled sensing of the evoked compound action potential (ECAP), a biopotential that represents neural activity elicited from SCS. The amplitudes of many SCS paradigms – both sub- and supra-threshold – are programmed relative to the patient’s perception of SCS. The objective of this study, then, is to elucidate relationships between the ECAP and perception thresholds across posture and SCS pulse width. These relationships may be used for the automatic control and perceptually referenced programming of SCS systems.MethodsECAPs were acquired from 14 subjects across a range of postures and pulse widths with swept amplitude stimulation. Perception (PT) and discomfort (DT) thresholds were recorded. A stimulation artifact reduction scheme was employed, and growth curves were constructed from the sweeps. An estimate of the ECAP threshold (ET), was calculated from the growth curves using a novel approach. Relationships between ET, PT, and DT were assessed.ResultsETs were estimated from 112 separate growth curves. For the postures and pulse widths assessed, the ET tightly correlated with both PT (r = 0.93; p < 0.0001) and DT (r = 0.93; p < 0.0001). The median accuracy of ET as a predictor for PT across both posture and pulse width was 0.5 dB. Intra-subject, ECAP amplitudes at DT varied up to threefold across posture.ConclusionWe provide evidence that the ET varies across both different positions and varying pulse widths and suggest that this variance may be the result of postural dependence of the recording electrode-tissue spacing. ET-informed SCS holds promise as a tool for SCS parameter configuration and may offer more accuracy over alternative approaches for neural and perceptual control in closed loop SCS systems.

No abstract

No abstract

No abstract