title: Rodent model for assessing the long term safety and performance of peripheral nerve recording electrodes.
abstract: In the US alone, there are approximately 185 000 cases of limb amputation annually, which can reduce the quality of life for those individuals. Current prosthesis technology could be improved by access to signals from the nervous system for intuitive prosthesis control. After amputation, residual peripheral nerves continue to convey motor signals and electrical stimulation of these nerves can elicit sensory percepts. However, current technology for extracting information directly from peripheral nerves has limited chronic reliability, and novel approaches must be vetted to ensure safe long-term use. The present study aims to optimize methods to establish a test platform using rodent model to assess the long term safety and performance of electrode interfaces implanted in the peripheral nerves.
  
  
  
  Floating Microelectrode Arrays (FMA, Microprobes for Life Sciences) were implanted into the rodent sciatic nerve. Weekly in vivo recordings and impedance measurements were performed in animals to assess performance and physical integrity of electrodes. Motor (walking track analysis) and sensory (Von Frey) function tests were used to assess change in nerve function due to the implant. Following the terminal recording session, the nerve was explanted and the health of axons, myelin and surrounding tissues were assessed using immunohistochemistry (IHC). The explanted electrodes were visualized under high magnification using scanning electrode microscopy (SEM) to observe any physical damage.
  
  
  
  Recordings of axonal action potentials demonstrated notable session-to-session variability. Impedance of the electrodes increased upon implantation and displayed relative stability until electrode failure. Initial deficits in motor function recovered by 2 weeks, while sensory deficits persisted through 6 weeks of assessment. The primary cause of failure was identified as lead wire breakage in all of animals. IHC indicated myelinated and unmyelinated axons near the implanted electrode shanks, along with dense cellular accumulations near the implant site. Scanning electron microscopy (SEM) showed alterations of the electrode insulation and deformation of electrode shanks.
  
  
  
  We describe a comprehensive testing platform with applicability to electrodes that record from the peripheral nerves. This study assesses the long term safety and performance of electrodes in the peripheral nerves using a rodent model. Under this animal test platform, FMA electrodes record single unit action potentials but have limited chronic reliability due to structural weaknesses. Future work will apply these methods to other commercially-available and novel peripheral electrode technologies.
authors.affiliation: Division of Biomedical Physics, Office of Science and Engineering Laboratory, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Srikanth
authors.initials: S
authors.lastname: Vasudevan
authors.forename: Kunal
authors.initials: K
authors.lastname: Patel
authors.forename: Cristin
authors.initials: C
authors.lastname: Welle
mesh_terms: D000200:Action Potentials / Q000502:physiology*; D000818:Animals; D017097:Electric Impedance; D004567:Electrodes, Implanted / Q000009:adverse effects*; D004568:Electrodiagnosis; D004867:Equipment Design; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D005260:Female; D008137:Longitudinal Studies; D008839:Microelectrodes / Q000009:adverse effects*; D059348:Peripheral Nerve Injuries / Q000209:etiology* / Q000517:prevention & control*; D010525:Peripheral Nerves / Q000502:physiology*; D051381:Rats; D011917:Rats, Inbred Lew