Chronic nerve health following implantation of femoral nerve cuff electrodes.
Action Potentials
Adult
Biomechanical Phenomena
Electric Stimulation Therapy
/ adverse effects
Electrodes, Implanted
/ adverse effects
Electrodiagnosis
Electromyography
Femoral Nerve
/ physiology
Humans
Knee
Male
Muscle Strength
Neural Prostheses
/ adverse effects
Paralysis
/ rehabilitation
Paraplegia
/ rehabilitation
Postoperative Complications
/ epidemiology
Spinal Cord Injuries
/ rehabilitation
Chronic nerve health
Electrical stimulation
Electrodiagnostics and neuromuscular diseases
Electromyography
Rehabilitation
Spinal cord injury
peripheral nerve cuff electrodes
Journal
Journal of neuroengineering and rehabilitation
ISSN: 1743-0003
Titre abrégé: J Neuroeng Rehabil
Pays: England
ID NLM: 101232233
Informations de publication
Date de publication:
14 07 2020
14 07 2020
Historique:
received:
25
09
2019
accepted:
06
07
2020
entrez:
16
7
2020
pubmed:
16
7
2020
medline:
15
12
2020
Statut:
epublish
Résumé
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. 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. 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. 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. ClinicalTrials.gov NCT01923662 , retrospectively registered August 15, 2013.
Sections du résumé
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.gov NCT01923662 , retrospectively registered August 15, 2013.
Identifiants
pubmed: 32664972
doi: 10.1186/s12984-020-00720-3
pii: 10.1186/s12984-020-00720-3
pmc: PMC7362538
doi:
Banques de données
ClinicalTrials.gov
['NCT01923662']
Types de publication
Case Reports
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
95Subventions
Organisme : NIBIB NIH HHS
ID : R01-EB001889
Pays : United States
Organisme : U.S. Department of Veterans Affairs
ID : I01-RX001039
Pays : International
Organisme : NIBIB NIH HHS
ID : T32 EB004314
Pays : United States
Organisme : NIGMS NIH HHS
ID : T32 GM007250
Pays : United States
Organisme : NCATS NIH HHS
ID : TL1 TR000441
Pays : United States
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