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

Isabela Peña Pino; Thomas E. Nightingale; Caleb Hoover; Zixi Zhao; Mark Cahalan; Tristan W. Dorey; Matthias Walter; Jan E. Soriano; Theoden I. Netoff; Ann Parr; Uzma Samadani; Aaron A. Phillips; Andrei V. Krassioukov; David P. Darrow

doi:10.1038/s41393-022-00822-w

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

Isabela Peña Pino, Thomas E. Nightingale, Caleb Hoover, Zixi Zhao, Mark Cahalan, Tristan W. Dorey, Matthias Walter, Jan E. Soriano, Theoden I. Netoff, Ann Parr, Uzma Samadani, Aaron A. Phillips, Andrei V. Krassioukov, David P. Darrow

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English (US)
Pages (from-to)	903-910
Number of pages	8
Journal	Spinal Cord
Volume	60
Issue number	10
DOIs	https://doi.org/10.1038/s41393-022-00822-w
State	Published - Oct 2022

Bibliographical note

Funding Information:
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 Information:
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.

Publisher Copyright:
© 2022, The Author(s), under exclusive licence to International Spinal Cord Society.

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Pino, I. P., Nightingale, T. E., Hoover, C., Zhao, Z., Cahalan, M., Dorey, T. W., Walter, M., Soriano, J. E., Netoff, T. I., Parr, A., Samadani, U., Phillips, A. A., Krassioukov, A. V., & Darrow, D. P. (2022). 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(10), 903-910. https://doi.org/10.1038/s41393-022-00822-w

Pino, IP, Nightingale, TE, Hoover, C, Zhao, Z, Cahalan, M, Dorey, TW, Walter, M, Soriano, JE, Netoff, TI , Parr, A, Samadani, U, Phillips, AA, Krassioukov, AV & Darrow, DP 2022, 'The safety of epidural spinal cord stimulation to restore function after spinal cord injury: post-surgical complications and incidence of cardiovascular events', Spinal Cord, vol. 60, no. 10, pp. 903-910. https://doi.org/10.1038/s41393-022-00822-w

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

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.",

author = "Pino, {Isabela Pe{\~n}a} and Nightingale, {Thomas E.} and Caleb Hoover and Zixi Zhao and Mark Cahalan and Dorey, {Tristan W.} and Matthias Walter and Soriano, {Jan E.} and Netoff, {Theoden I.} and Ann Parr and Uzma Samadani and Phillips, {Aaron A.} and Krassioukov, {Andrei V.} and Darrow, {David P.}",

note = "Funding Information: 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 Information: 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. Publisher Copyright: {\textcopyright} 2022, The Author(s), under exclusive licence to International Spinal Cord Society.",

year = "2022",

month = oct,

doi = "10.1038/s41393-022-00822-w",

language = "English (US)",

volume = "60",

pages = "903--910",

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T1 - The safety of epidural spinal cord stimulation to restore function after spinal cord injury

T2 - post-surgical complications and incidence of cardiovascular events

AU - Pino, Isabela Peña

AU - Nightingale, Thomas E.

AU - Hoover, Caleb

AU - Zhao, Zixi

AU - Cahalan, Mark

AU - Dorey, Tristan W.

AU - Walter, Matthias

AU - Soriano, Jan E.

AU - Netoff, Theoden I.

AU - Parr, Ann

AU - Samadani, Uzma

AU - Phillips, Aaron A.

AU - Krassioukov, Andrei V.

AU - Darrow, David P.

N1 - Funding Information: 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 Information: 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. Publisher Copyright: © 2022, The Author(s), under exclusive licence to International Spinal Cord Society.

PY - 2022/10

Y1 - 2022/10

N2 - 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.

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

Abstract

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