Evidence map›Paper›PMID 35701485›Full record

Trial reportSpinal cord2022

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 and 4 more

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Spinal cord, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Recent updates in autonomic research: advances in the understanding of autonomic dysfunction after spinal cord injury.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2023
    Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Isabela Peña Pino *Department of Biomedical Engineering, University of Minnesota, Minneapolis, MN, USA.
Thomas E Nightingale *School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.
Caleb HooverDepartment of Bioinformatics and Computational Biology, University of Minnesota, Minneapolis, MN, USA.
Zixi ZhaoDepartment of Biomedical Engineering, University of Minnesota, Minneapolis, MN, USA.
Mark CahalanMD Undergraduate Program, Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada.
Tristan W DoreyCardiovascular and Respiratory Science, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Matthias WalterInternational Collaboration on Repair Discoveries (ICORD), University of British Columbia (UBC), Vancouver, BC, Canada.ORCID 0000-0001-5347-1584
Jan E SorianoDepartments of Physiology and Pharmacology, Cardiac Sciences, Clinical Neurosciences, Hotchkiss Brain Institute, Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.ORCID 0000-0001-5553-0808
Theoden I NetoffDepartment of Biomedical Engineering, University of Minnesota, Minneapolis, MN, USA.
Ann ParrDepartment of Neurosurgery, University of Minnesota, Minneapolis, MN, USA.
Uzma SamadaniDepartment of Bioinformatics and Computational Biology, University of Minnesota, Minneapolis, MN, USA.
Aaron A PhillipsDepartments of Physiology and Pharmacology, Cardiac Sciences, Clinical Neurosciences, Hotchkiss Brain Institute, Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Andrei V KrassioukovInternational Collaboration on Repair Discoveries (ICORD), University of British Columbia (UBC), Vancouver, BC, Canada. krassioukov@icord.org.ORCID 0000-0002-0022-7972
David P DarrowDepartment of Neurosurgery, University of Minnesota, Minneapolis, MN, USA. darro015@umn.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designCohort prospective study.

objectivesEpidural 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.

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

methodsMonthly 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.

resultsAll 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.

conclusionseSCS 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.

Indexed as

Cardiovascular DiseasesChronic PainSpinal Cord InjuriesSpinal Cord StimulationHumansIncidenceProspective StudiesSpinal Cord

Identifiers

PMID35701485

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.