Isabela Peña Pino1,2,3, Thomas E Nightingale4,5,6, Caleb Hoover7, Zixi Zhao1, Mark Cahalan8, Tristan W Dorey9, Matthias Walter5,10, Jan E Soriano11, Theoden I Netoff1, Ann Parr2, Uzma Samadani7,12, Aaron A Phillips11, Andrei V Krassioukov13,14,15, David P Darrow16,17. 1. Department of Biomedical Engineering, University of Minnesota, Minneapolis, MN, USA. 2. Department of Neurosurgery, University of Minnesota, Minneapolis, MN, USA. 3. Division of Neurosurgery, Hennepin County Medical Center, Minneapolis, MN, USA. 4. School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK. 5. International Collaboration on Repair Discoveries (ICORD), University of British Columbia (UBC), Vancouver, BC, Canada. 6. Centre for Trauma Sciences Research, University of Birmingham, Edgbaston, Birmingham, UK. 7. Department of Bioinformatics and Computational Biology, University of Minnesota, Minneapolis, MN, USA. 8. MD Undergraduate Program, Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada. 9. Cardiovascular and Respiratory Science, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. 10. Department of Urology, University Hospital Basel, University of Basel, Basel, Switzerland. 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. 12. Minneapolis Veterans Affairs Medical Center, Minneapolis, MN, USA. 13. International Collaboration on Repair Discoveries (ICORD), University of British Columbia (UBC), Vancouver, BC, Canada. krassioukov@icord.org. 14. Department of Medicine, Division of Physical Medicine and Rehabilitation, UBC, Vancouver, BC, Canada. krassioukov@icord.org. 15. GF Strong Rehabilitation Centre, Vancouver Coastal Health, Vancouver, BC, Canada. krassioukov@icord.org. 16. Department of Neurosurgery, University of Minnesota, Minneapolis, MN, USA. darro015@umn.edu. 17. Division of Neurosurgery, Hennepin County Medical Center, Minneapolis, MN, USA. darro015@umn.edu.
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.
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.