A Novel Pulsed Stimulation Pattern in Spinal Cord Stimulation: Clinical Results and Postulated Mechanisms of Action in the Treatment of Chronic Low Back and Leg Pain

Authors

Mehul J. Desai, International Spine, Pain & Performance Center, Washington, DC, USA; School of Medicine and Health Sciences, George Washington University, Washington, DC, USA. Electronic address: drdesai@isppcenter.com.
John Salmon, Department of Pain Management, Pain Care Perth and Western Australia, Perth, Western Australia, Australia.
Paul Verrills, Department of Pain Management, Metro Pain, Melbourne, Victoria, Australia.
Bruce Mitchell, Department of Pain Management, Metro Pain, Melbourne, Victoria, Australia.
Neels Du Toit, Department of Pain Management, Metro Pain, Melbourne, Victoria, Australia.
Dan Bates, Department of Pain Management, Metro Pain, Melbourne, Victoria, Australia.
Girish Vajramani, Department of Neurosurgery, University Hospital Southampton, Southampton, UK.
Adam Williams, Department of Neurosurgery, University of Bristol, Bristol, UK.
Sarah Love-Jones, Department of Pain Management, North Bristol National Health Service Trust, Bristol, UK.
Nikunj Patel, Department of Neurosurgery, North Bristol National Health Service Trust, Bristol, UK.
Serge Nikolic, Department of Pain Management, St Bartholomew's Hospital, London, UK.
Vivek Mehta, Department of Pain Management, St Bartholomew's Hospital, London, UK.
Alia Ahmad, Department of Pain Management, St Bartholomew's Hospital, London, UK.
James Yu, Department of Pain Management, Sydney Spine and Pain, Sydney, New South Wales, Australia.
Nick Christellis, Department of Pain Management, Pain Specialists Australia, Richmond, New South Wales, Australia.
Sam Harkin, Department of Pain Management, Pain Specialists Australia, Richmond, New South Wales, Australia.
Ganesan Baranidharan, Department of Pain Management, Leeds Teaching Hospital National Health Service Trust, Leeds, UK.
Robert Levy, Department of Neurosurgery, Institute for Neuromodulation, Boca Raton, FL, USA.
Peter Staats, Department of Pain Management, Premier Pain Centers, Shrewsbury, NJ, USA.
Mark N. Malinowski, OhioHealth, Columbus, OH, USA.
James Makous, Makous Research, LLC, Carlsbad, CA, USA.
Nicholas Sullivan, Nalu Medical, Carlsbad, CA, USA.
Shilpa Kottalgi, Nalu Medical, Carlsbad, CA, USA.
Melissa Hartley, Nalu Medical, Carlsbad, CA, USA.
Lakshmi Narayan Mishra, Nalu Medical, Carlsbad, CA, USA.

Document Type

Journal Article

Publication Date

12-8-2022

Journal

Neuromodulation : journal of the International Neuromodulation Society

DOI

10.1016/j.neurom.2022.10.053

Keywords

Chronic pain; mechanism of action; persistent spinal pain syndrome; pulsed stimulation pattern; spinal cord stimulation

Abstract

OBJECTIVES: The aim of this article is to discuss the possible mechanisms of action (MOAs) and results of a pilot study of a novel, anatomically placed, and paresthesia-independent, neurostimulation waveform for the management of chronic intractable pain. MATERIALS AND METHODS: A novel, multilayered pulsed stimulation pattern (PSP) that comprises three temporal layers, a Pulse Pattern layer, Train layer, and Dosage layer, was developed for the treatment of chronic intractable pain. During preliminary development, the utility was evaluated of anatomical PSP (aPSP) in human subjects with chronic intractable pain of the leg(s) and/or low back, compared with that of traditional spinal cord stimulation (T-SCS) and physiological PSP. The scientific theory and testing presented in this article provide the preliminary justification for the potential MOAs by which PSP may operate. RESULTS: During the pilot study, aPSP (n = 31) yielded a greater decrease in both back and leg pain than did T-SCS (back: -60% vs -46%; legs: -63% vs -43%). In addition, aPSP yielded higher responder rates for both back and leg pain than did T-SCS (61% vs 48% and 78% vs 50%, respectively). DISCUSSION: The novel, multilayered approach of PSP may provide multimechanistic therapeutic relief through preferential fiber activation in the dorsal column, optimization of the neural onset response, and use of both the medial and lateral pathway through the thalamic nuclei. The results of the pilot study presented here suggest a robust responder rate, with several subjects (five subjects with back pain and three subjects with leg pain) achieving complete relief from PSP during the acute follow-up period. These clinical findings suggest PSP may provide a multimechanistic, anatomical, and clinically effective management for intractable chronic pain. Because of the limited sample size of clinical data, further testing and long-term clinical assessments are warranted to confirm these preliminary findings.

APA Citation

Desai, Mehul J.; Salmon, John; Verrills, Paul; Mitchell, Bruce; Du Toit, Neels; Bates, Dan; Vajramani, Girish; Williams, Adam; Love-Jones, Sarah; Patel, Nikunj; Nikolic, Serge; Mehta, Vivek; Ahmad, Alia; Yu, James; Christellis, Nick; Harkin, Sam; Baranidharan, Ganesan; Levy, Robert; Staats, Peter; Malinowski, Mark N.; Makous, James; Sullivan, Nicholas; Kottalgi, Shilpa; Hartley, Melissa; and Mishra, Lakshmi Narayan, "A Novel Pulsed Stimulation Pattern in Spinal Cord Stimulation: Clinical Results and Postulated Mechanisms of Action in the Treatment of Chronic Low Back and Leg Pain" (2022). GW Authored Works. Paper 2123.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/2123

Department

Anesthesiology and Critical Care Medicine