TY - JOUR
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 - 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.
UR - http://www.scopus.com/inward/record.url?scp=85131782674&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85131782674&partnerID=8YFLogxK
U2 - 10.1038/s41393-022-00822-w
DO - 10.1038/s41393-022-00822-w
M3 - Article
C2 - 35701485
AN - SCOPUS:85131782674
SN - 1362-4393
VL - 60
SP - 903
EP - 910
JO - Spinal Cord
JF - Spinal Cord
IS - 10
ER -