First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain

Harold J.A. Nijhuis*, Willem Jan Hofsté, Imre P. Krabbenbos, Birte E. Dietz, Dave Mugan, Frank Huygen

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Scopus)
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Abstract

Introduction: A novel closed-loop spinal cord stimulation (SCS) system has recently been approved for use which records evoked compound action potentials (ECAPs) from the spinal cord and utilizes these recordings to automatically adjust the stimulation strength in real time. It automatically compensates for fluctuations in distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a determined target level. This data collection was principally designed to evaluate the performance of this first closed-loop SCS system in a ‘real-world’ setting under normal conditions of use in a single European center. Methods: In this prospective, single-center observational data collection, 22 patients were recruited at the outpatient pain clinic of the St. Antonius Hospital. All candidates were suffering from chronic pain in the trunk and/or limbs due to PSPS type 2 (persistent spinal pain syndrome). As standard of care, follow-up visits were completed at 3 months, 6 months, and 12 months post-device activation. Patient-reported outcome data (pain intensity, patient satisfaction) and electrophysiological and device data (ECAP amplitude, conduction velocity, current output, pulse width, frequency, usage), and patient interaction with their controller were collected at baseline and during standard of care follow-up visits. Results: Significant decreases in pain intensity for overall back or leg pain scores (verbal numerical rating score = VNRS) were observed between baseline [mean ± SEM (standard error of the mean); n = 22; 8.4 ± 0.2)], 3 months (n = 12; 1.9 ± 0.5), 6 months (n = 16; 2.6 ± 0.5), and 12 months (n = 20; 2.0 ± 0.5), with 85.0% of the patients being satisfied at 12 months. Additionally, no significant differences in average pain relief at 3 months and 12 months between the real-world data (77.2%; 76.8%) and the AVALON (71.2%; 73.6%) and EVOKE (78.1%; 76.7%) studies were observed. Conclusions: These initial ‘real-world’ data on ECAP-controlled, closed-loop SCS in a real-world clinical setting appear to be promising, as they provide novel insights of the beneficial effect of ECAP-controlled, closed-loop SCS in a real-world setting. The presented results demonstrate a noteworthy maintenance of pain relief over 12 months and corroborate the outcomes observed in the AVALON prospective, multicenter, single-arm study and the EVOKE double-blind, multicenter, randomized controlled trial. Trial Registration: The data collection is registered on the International Clinical Trials Registry Platform (Trial NL7889).

Original languageEnglish
Pages (from-to)1221-1233
Number of pages13
JournalPain and Therapy
Volume12
Issue number5
DOIs
Publication statusPublished - Oct 2023

Bibliographical note

Funding Information:
The study was sponsored by Saluda Medical. The authors gratefully thank the participants of the study and acknowledge the Antonius Hospital Unit for their support and assistance in this work and would also like to thank Ralph Aarsman, Gerry Aikema, Joris Brouns and Maeve Willen for their support during data collection and analysis. This study was sponsored and funded by Saluda Medical. The sponsor funded the publication review and the Rapid Service Fee. We confirm that this manuscript has not been published elsewhere and is not under consideration by another journal. Harold Nijhuis conducted the study including data collection and analysis, conducted statistical analysis and interpretation of the data, and wrote the manuscript; Frank Huygen interpreted the data and reviewed and edited the manuscript; Willem-Jan Hofsté conducted the study including data collection and reviewed and edited the manuscript; Imre P. Krabbebos conducted the study including data collection and reviewed and edited the manuscript; Dave Mugan designed the study, interpreted the data and wrote the manuscript; Birte E. Dietz performed data and statistical analysis, interpretation of the data, and wrote the manuscript; All authors approved the final manuscript and agree with its submission. Harold Nijhuis is a paid consultant for Saluda Medical, Abbott, and Salvia. Harold Nijhuis has a research grant with Abbott. Frank Huygen reports personal fees from Abbott, grants, personal fees from Saluda, personal fees from Boston Scientific, personal fees from Grunenthal, personal fees from Pfizer, outside the submitted work. Willem-Jan Hofsté is a paid consultant for Saluda Medical and Abbott. Birte E. Dietz and Dave Mugan are employed by Saluda Medical. There are no other relationships that might lead to a conflict of interest in the current study. This observational data collection adhered to the ethical principles of the Declaration of Helsinki. In the Netherlands, a prospective data collection without any intervention does not fall under the Medical Research Involving Human Subject Act (WMO). This means that no medical ethical committee approval is required for this type of study in the Netherlands, as confirmed by the ethical committee (Amsterdam University Medical Centers, W17_309#17.362). The data was available for review by all the contributing authors. All data generated or analyzed during this study are included in this published article.

Funding Information:
The study was sponsored by Saluda Medical. The authors gratefully thank the participants of the study and acknowledge the Antonius Hospital Unit for their support and assistance in this work and would also like to thank Ralph Aarsman, Gerry Aikema, Joris Brouns and Maeve Willen for their support during data collection and analysis.

Funding Information:
Harold Nijhuis is a paid consultant for Saluda Medical, Abbott, and Salvia. Harold Nijhuis has a research grant with Abbott. Frank Huygen reports personal fees from Abbott, grants, personal fees from Saluda, personal fees from Boston Scientific, personal fees from Grunenthal, personal fees from Pfizer, outside the submitted work. Willem-Jan Hofsté is a paid consultant for Saluda Medical and Abbott. Birte E. Dietz and Dave Mugan are employed by Saluda Medical. There are no other relationships that might lead to a conflict of interest in the current study.

Publisher Copyright:
© 2023, The Author(s).

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