First-in-human implementation of a bidirectional somatosensory neuroprosthetic system with wireless communication.

Abstract

Background: Limitations in upper limb prosthesis function and lack of sensory feedback are major contributors to high prosthesis abandonment rates. Peripheral nerve stimulation and intramuscular recording can restore touch and relay motor intentions for individuals with upper limb loss. Percutaneous systems have enabled significant progress in implanted neural interfaces but require chronic lead maintenance and unwieldy external equipment. Fully implanted sensorimotor systems without percutaneous leads are crucial for advancing implanted neuroprosthetic technologies to long-term community use and commercialization.

Methods: We present the first-in-human technical performance of the implanted Somatosensory Electrical Neurostimulation and Sensing (iSens®) system-an implanted, high-channel count myoelectric sensing and nerve stimulation system that uses wireless communication for advanced prosthetic systems. Two individuals with unilateral transradial amputations received iSens® with four 16-channel composite Flat Interface Nerve Electrodes (C-FINEs) and four Tetra Intramuscular (TIM) electrodes. This study achieved two key objectives to demonstrate system feasibility prior to long-term community use: (1) evaluating the chronic stability of extraneural cuff electrodes, intramuscular electrodes, and active implantable devices in a wirelessly connected system and (2) assessing the impacts of peripheral nerve stimulation on three degree-of-freedom controller performance in a wirelessly connected system to validate iSens® as a bidirectional interface.

Results: Similar to prior percutaneous systems, we demonstrate chronically stable extraneural cuff electrodes and intramuscular electrodes in a wirelessly connected implanted system for more than two years in one participant and four months in the second participant, whose iSens® system was explanted due to an infection of unknown origin. Using an artificial neural network controller trained on implanted electromyographic data collected during known hand movements, one participant commanded a virtual hand and sensorized prosthesis in 3 degrees-of-freedom. The iSens® system simultaneously produced stimulation for sensation while recording high resolution muscle activity for real-time control. Although restored sensation did not significantly improve initial trials of prosthetic controller performance, the participant reported that sensation was helpful for functional tasks.

Conclusions: This case series describes a wirelessly connected, bidirectional neuroprosthetic system with somatosensory feedback and advanced myoelectric prosthetic control that is ready for implementation in long-term home use clinical trials.

Trial registration: ClinicalTrials.gov ID: NCT04430218, 2020-06-30.