A rat model for assessing the long-term safety and performance of peripheral nerve electrode arrays

High-resolution peripheral nerve interfaces (PNIs) can provide amputees with intuitive motor control and sensory feedback. Current PNIs are limited by early device failure and suboptimal long-term stability. The present study aims to incorporate functional assessment into an in vivo test platform to assess the long-term safety and performance of PNIs for recording and stimulation.

Utah electrode arrays (EA) were implanted in the rat sciatic nerve along with electromyography wires in the gastrocnemius and tibialis anterior. Cranial EEG screws were implanted in the somatosensory cortex for 12 weeks. Spontaneous neural activity was recorded using the implanted EA and stimulation-induced activity was monitored throughout the experiment. The impedance of each electrode was measured, and nerve function tests were conducted throughout the EA lifetime. Post-hoc safety assessments included scanning electron microscopy (SEM) of the EA and nerve histomorphometric analysis.

EA recordings were stable, and stimulation with EA elicited somatosensory evoked potentials and muscle contractions. Motor and sensory function tests indicated minimal deficits. Histomorphometric analysis indicated changes in nerve microstructure. SEM indicated EA-tip fracture, while lead wire breakage primarily caused device failure.

We improved our prior platform with the addition of functional assessments of sensory pathways, a robust EMG array design to increase device longevity, and quantitative analysis of nerve microstructure.

We present a test platform for long-term assessment of peripheral nerve interfaces for stimulation and recording. Using this platform, we demonstrate recording and stimulation with minimal impact on nerve function, while EA lead wire breakage and tip fracture could limit long-term device use.