Chronic Nerve Health Following Implantation of Nerve Cuff Electrodes Designed for the Proximal Femoral Nerve

Neurology(2018)

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Abstract
Objective: This is the first in-human, year-long study to quantify the electrodiagnostic consequences in nerve physiology following implantation of a novel nerve cuff electrode (NCE) implanted around the proximal femoral nerves, near the inguinal ligament. Background: Peripheral nerve stimulation with implanted NCEs can modulate the motor, sensory, and autonomic nervous system. Following spinal cord injury, these electrodes can restore standing and stepping function to paraplegic patients. However, there is an absence of clinical data evaluating the chronic impact of NCEs on nerve health in human subjects. Design/Methods: We previously designed directionally-flexible NCEs to accommodate nerve bending and provide gentle nerve reshaping for improved selectivity of fascicular stimulation. Successful animal testing permitted implantation on bilateral femoral nerves, proximal to the branch innervating the sartorius muscle. They were deployed as part of a standing neuroprosthesis in a man with bilateral lower extremity paralysis secondary to long-standing cervical spinal cord injury. Electromyography quantified neurophysiology preoperatively through 1-year postoperatively. Stimulation charge thresholds and evoked knee extension moments quantified neuroprosthesis function. Results: Femoral compound motor unit action potentials increased by 31% in amplitude and 34% in area, while evoked knee extension moments increased significantly (p Conclusions: This is the first human trial reporting acute and chronic neurophysiologic changes following implantation of and stimulation through NCEs. Electrodiagnostics indicated preserved nerve health with increased motor responses following exercise. Temporary electrodiagnostic changes suggest minor nerve irritation perioperatively. Functional results indicated that these NCEs recruited muscles selectively and stabilized function quickly. These year-long outcomes demonstrate the ability to safely implant NCEs near joints. Study Supported by: This research was funded by R01-EB001889 from the National Institute of Biomedical Imaging and Bioengineering of the NIH and by I01-RX001039 from the US Department of Veterans Affairs. This research was supported by NIH training grants T32- EB004314, T32- GM007250, and TL1- TR000441 and with resources provided by the Advanced Platform Technology (APT) Center of Excellence of the Louis Stokes Cleveland VA Medical Center, which is supported by NIH grant I50-RX001871. Disclosure: Dr. Freeberg has nothing to disclose. Dr. Pinault has nothing to disclose. Dr. Tyler has nothing to disclose. Dr. Triolo has nothing to disclose. Dr. Ansari has nothing to disclose.
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Key words
Nerve Transfer,Prosthetic Control
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