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The safety of epidural spinal cord stimulation to restore function after spinal cord injury: post-surgical complications and incidence of cardiovascular events

Spinal Cord volume 60, pages 903–910 (2022)Cite this article

Subjects

Abstract

Study design

Cohort prospective study.

Objectives

Epidural spinal cord stimulation (eSCS) improves volitional motor and autonomic function after spinal cord injury (SCI). While eSCS has an established history of safety for chronic pain, it remains unclear if eSCS in the SCI population presents the same risk profile. We aimed to assess safety and autonomic monitoring data for the first 14 participants in the E-STAND trial.

Setting

Hennepin County Medical Center, Minneapolis and Minneapolis Veterans Affairs Medical Center, Minnesota, USA.

Methods

Monthly follow-up visits assessed surgical and medical device-related safety outcomes as well as stimulation usage. Beat-by-beat blood pressure (BP) and continuous electrocardiogram data were collected during head-up tilt-table testing with and without eSCS.

Results

All participants had a motor-complete SCI. Mean (SD) age and time since injury were 38 (10) and 7 (5) years, respectively. There were no surgical complications but one device malfunction 4 months post implantation. Stimulation was applied for up to 23 h/day, across a broad range of parameters: frequency (18–700 Hz), pulse width (100–600 µs), and amplitude (0.4–17 mA), with no adverse events reported. Tilt-table testing with eSCS demonstrated no significant increases in the incidence of elevated systolic BP or a greater frequency of arrhythmias.

Conclusions

eSCS to restore autonomic and volitional motor function following SCI has a similar safety profile as when used to treat chronic pain, despite the prevalence of significant comorbidities and the wide variety of stimulation parameters tested.

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Fig. 1: The above vignette is a representative trace showing cardiovascular responses (SBP and DBP and HR) for an autonomic study participant (participant 10) during a standard autonomic assessment.
Fig. 2: Summary of SBP data.
Fig. 3: HR and arrhythmia analysis in response to eSCS.
Fig. 4: Daily and cumulative stimulation delivered at home during study enrollment.
Fig. 5: Stimulation parameter space exploration and energy delivered for participant 10 during follow-up month 2–7.

Data availability

Data will be made available upon reasonable request.

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Acknowledgements

We would like to thank the Minnesota Office of Higher Education SCI/TBI Grant Program for the funding to carry out this study and St. Jude/Abbott for a generous device donation. We would like to acknowledge the E-STAND study group in both Minnesota and Canada for carrying out study procedures. The authors would like to thank the participants of this study and study coordinators who were crucial for the success of the present study.

Funding

This study is funded by a MN State SCI/TBI grant from the Minnesota Office of Higher Education. Devices are donated by Abbott/St. Jude. AVK holds the Endowed Chair in Rehabilitation Medicine, UBC. TEN (grant number: 17767) and MW (grant number: 17110) were recipients of Michael Smith Foundation for Health Research Trainee Awards in conjunction with the International Collaboration on Repair Discoveries and Rick Hansen Foundation, respectively.

Author information

Author notes

  1. These authors contributed equally: Isabela Peña Pino, Thomas E. Nightingale.

Authors and Affiliations

  1. Department of Biomedical Engineering, University of Minnesota, Minneapolis, MN, USA

    Isabela Peña Pino, Zixi Zhao & Theoden I. Netoff

  2. Department of Neurosurgery, University of Minnesota, Minneapolis, MN, USA

    Isabela Peña Pino, Ann Parr & David P. Darrow

  3. Division of Neurosurgery, Hennepin County Medical Center, Minneapolis, MN, USA

    Isabela Peña Pino & David P. Darrow

  4. School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK

    Thomas E. Nightingale

  5. International Collaboration on Repair Discoveries (ICORD), University of British Columbia (UBC), Vancouver, BC, Canada

    Thomas E. Nightingale, Matthias Walter & Andrei V. Krassioukov

  6. Centre for Trauma Sciences Research, University of Birmingham, Edgbaston, Birmingham, UK

    Thomas E. Nightingale

  7. Department of Bioinformatics and Computational Biology, University of Minnesota, Minneapolis, MN, USA

    Caleb Hoover & Uzma Samadani

  8. MD Undergraduate Program, Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada

    Mark Cahalan

  9. Cardiovascular and Respiratory Science, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada

    Tristan W. Dorey

  10. Department of Urology, University Hospital Basel, University of Basel, Basel, Switzerland

    Matthias Walter

  11. Departments of Physiology and Pharmacology, Cardiac Sciences, Clinical Neurosciences, Hotchkiss Brain Institute, Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada

    Jan E. Soriano & Aaron A. Phillips

  12. Minneapolis Veterans Affairs Medical Center, Minneapolis, MN, USA

    Uzma Samadani

  13. Department of Medicine, Division of Physical Medicine and Rehabilitation, UBC, Vancouver, BC, Canada

    Andrei V. Krassioukov

  14. GF Strong Rehabilitation Centre, Vancouver Coastal Health, Vancouver, BC, Canada

    Andrei V. Krassioukov

Authors
  1. Isabela Peña Pino
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Contributions

The study was conceived and designed by DPD, AP, and AVK. TIN, AP, US provided conceptual and technical guidance for all aspects of the study. IPP, TEN, CH, ZZ, JES, MW collected the data. IPP, TEN, ZZ, MC, TWD, MW, JES, and TIN performed data analysis and interpretation. IPP, TEN, MC, TWD, MW, TIN drafted the article. All authors provided critical revision of the manuscript and final approval of the version to be published.

Corresponding authors

Correspondence to Andrei V. Krassioukov or David P. Darrow.

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Competing interests

The authors declare no competing interests.

Ethical approval

Approval for this study was provided by the institutional review boards of both Hennepin County Medical Center and the Minneapolis Veterans Affairs Medical Center. We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research.

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Pino, I.P., Nightingale, T.E., Hoover, C. et al. The safety of epidural spinal cord stimulation to restore function after spinal cord injury: post-surgical complications and incidence of cardiovascular events. Spinal Cord 60, 903–910 (2022). https://doi.org/10.1038/s41393-022-00822-w

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