Evidence map›Paper›PMID 32664972›Full record

ArticleJournal of neuroengineering and rehabilitation2020

Chronic nerve health following implantation of femoral nerve cuff electrodes.

Max J Freeberg, Gilles C J Pinault, Dustin J Tyler, Ronald J Triolo, Rahila Ansari

Registry-linked trialAbstract readCase Reports
In one paragraph

Article in Journal of neuroengineering and rehabilitation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01923662 (Exploiting Selective Recruitment to Prolong Standing After SCI), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT01923662 nacompletednot on this map

Exploiting Selective Recruitment to Prolong Standing After SCI

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2013 to 2024Enrolled6ConditionsSpinal Cord Injury, Paralysis, Tetraplegia, ParaplegiaArmsIST-16 (16-Channel implanted stimulator-telemeter
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Intraoperative Responses May Predict Chronic Performance of Composite Flat Interface Nerve Electrodes on Human Femoral Nerves.IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society · 2019
    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

5 authors.

Max J FreebergDepartment of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA. mxf218@case.edu.ORCID 0000-0002-4976-5405
Gilles C J PinaultAdvanced Platform Technology (APT) Center, Cleveland, OH, USA.
Dustin J TylerDepartment of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA.
Ronald J TrioloDepartment of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA.
Rahila AnsariAdvanced Platform Technology (APT) Center, Cleveland, OH, USA.

Funding

MEDICAL SCIENTIST TRAINING PROGRAMT32GM007250 · NIGMS · CASE WESTERN RESERVE UNIVERSITY · PI HUANG, ALEX YEE-CHEN · 1985 to 2023
$33.4M
Integrated Neural Engineering and Rehabilitation Training ProgramT32EB004314 · NIBIB · CASE WESTERN RESERVE UNIVERSITY · PI Jeffrey R Capadona, Robert F. Kirsch · 2004 to 2026
$6.1M
NEUROPROSTHESIS PERFORMANCE - NERVE CUFF ELECTRODESR01EB001889 · NIBIB · CASE WESTERN RESERVE UNIVERSITY · PI TRIOLO, RONALD J, TYLER, DUSTIN J. · 2003 to 2017
$5.9M
Clinical and Translational Science Collaborative of ClevelandTL1TR000441 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$2.8M
NCATS NIH HHS TL1 TR000441NIBIB NIH HHS R01 EB001889NIBIB NIH HHS R01-EB001889NIBIB NIH HHS T32 EB004314NIGMS NIH HHS T32 GM007250RRD VA I01 RX001039
6 · The paper itself

Abstract

backgroundPeripheral nerve stimulation with implanted nerve cuff electrodes can restore standing, stepping and other functions to individuals with spinal cord injury (SCI). We performed the first study to evaluate the clinical electrodiagnostic changes due to electrode implantation acutely, chronic presence on the nerve peri- and post-operatively, and long-term delivery of electrical stimulation.

methodsA man with bilateral lower extremity paralysis secondary to cervical SCI sustained 5 years prior to enrollment received an implanted standing neuroprosthesis including composite flat interface nerve electrodes (C-FINEs) electrodes implanted around the proximal femoral nerves near the inguinal ligaments. Electromyography quantified neurophysiology preoperatively, intraoperatively, and through 1 year postoperatively. Stimulation charge thresholds, evoked knee extension moments, and weight distribution during standing quantified neuroprosthesis function over the same interval.

resultsFemoral compound motor unit action potentials increased 31% in amplitude and 34% in area while evoked knee extension moments increased significantly (p < 0.01) by 79% over 1 year of rehabilitation with standing and quadriceps exercises. Charge thresholds were low and stable, averaging 19.7 nC ± 6.2 (SEM). Changes in saphenous nerve action potentials and needle electromyography suggested minor nerve irritation perioperatively.

conclusionsThis is the first human trial reporting acute and chronic neurophysiologic changes due to application of and stimulation through nerve cuff electrodes. Electrodiagnostics indicated preserved nerve health with strengthened responses following stimulated exercise. Temporary electrodiagnostic changes suggest minor nerve irritation only intra- and peri-operatively, not continuing chronically nor impacting function. These outcomes follow implantation of a neuroprosthesis enabling standing and demonstrate the ability to safely implant electrodes on the proximal femoral nerve close to the inguinal ligament. We demonstrate the electrodiagnostic findings that can be expected from implanting nerve cuff electrodes and their time-course for resolution, potentially applicable to prostheses modulating other peripheral nerves and functions.

trial registrationClinicalTrials.gov NCT01923662 , retrospectively registered August 15, 2013.

Indexed as

Action PotentialsAdultBiomechanical PhenomenaElectric Stimulation TherapyElectrodes, ImplantedElectrodiagnosisElectromyographyFemoral NerveHumansKneeMaleMuscle StrengthNeural ProsthesesParalysisParaplegiaPostoperative ComplicationsChronic nerve healthElectrical stimulationElectrodiagnostics and neuromuscular diseasesElectromyographyperipheral nerve cuff electrodesRehabilitationSpinal cord injury

Identifiers

PMID32664972
PMCPMC7362538

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.