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Published in: Journal of NeuroEngineering and Rehabilitation 1/2020

Open Access 01-12-2020 | Research

Chronic nerve health following implantation of femoral nerve cuff electrodes

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

Published in: Journal of NeuroEngineering and Rehabilitation | Issue 1/2020

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Abstract

Background

Peripheral 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.

Methods

A 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.

Results

Femoral 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.

Conclusions

This 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 registration

ClinicalTrials.​govNCT01923662, retrospectively registered August 15, 2013.
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Metadata
Title
Chronic nerve health following implantation of femoral nerve cuff electrodes
Authors
Max J. Freeberg
Gilles C. J. Pinault
Dustin J. Tyler
Ronald J. Triolo
Rahila Ansari
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Journal of NeuroEngineering and Rehabilitation / Issue 1/2020
Electronic ISSN: 1743-0003
DOI
https://doi.org/10.1186/s12984-020-00720-3

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