Restoring sensation with a neural-enabled prosthetic hand system for home use: a first-in-human study
Abstract
As we use a hand to manipulate an object, high quality control is enabled by sensors in the hand. TodayÕs motorized upper limb prostheses do not afford amputees with high quality control due to the lack of critical information such as contact force and hand opening, which results in an increased reliance on visual feedback and high attentional demands. It follows that there is a large population of individuals with amputation whose needs are not being fully met by current prosthetic hand technology, which results in reduced quality of life. The limitations of existing technology negatively impact the lives of those who have lost one hand, but the impact is much more profound for those who have lost multiple limbs, as is the case with many Service Members and Veterans. Advanced prosthetic technologies, such as those that provide sensation, have great potential to improve the quality of life for injured warfighters and civilians who have experienced limb loss. Our team has developed an Adaptive Neural Systems-Neural Enabled Prosthetic Hand (ANS-NEPH) system to provide amputees with sensations that are synchronized with sensor-derived signals from the prosthesis. The system includes an implantable neural stimulation device and a prosthetic hand with embedded sensors to continuously measure hand opening and grip force. It communicates information from the embedded sensors to the implanted stimulator through a wireless link. The neurostimulaor excites nerves via fine-wire longitudinal intrafascicular electrodes (LIFEs) implanted in peripheral nerves of the residual limb to elicit sensations that are referred to the phantom hand. The system has been designed for ease-of-use and the procedures required for daily use are comparable to those required for todayÕs commercially-available prostheses. In the project, the clinical safety and functionality of the ANS-NEPH system will be evaluated in a first-in-human clinical trial. Two subjects will be enrolled in a staged manner to participate in this long-term (2-years) study. Each subject will have the implanted components surgically installed, be fitted with the external components of the system, be trained in the use of the system, participate in an extensive series of experiments designed to assess long-term viability of our approach, and use it on a regular basis as their primary prosthetic hand. Laboratory-based studies will monitor system viability, characterize the sensations elicited by stimulation, and assess the impact of stimulation on the userÕs ability to control the prosthesis. Use in real-world environments will provide data to understand the potential utility of a sensory-enabled prosthesis for routine tasks. In this project, the original version of the system will be upgraded to enable home use monitoring, which will be used to monitor and document usage of the system outside the laboratory. At the conclusion of their participation in the protocol, the subjects will have the option to keep the system. To the best of our knowledge, this is the first wirelessly-controlled, neural-enabled prosthetic hand that provides sensation and is suitable for daily use at home and in other settings. With regular use in real-world environments, this study will present challenges to the robustness and versality of the system that will help to characterize its utility and identify areas for improvement. In addition, this study will enable investigations of the effects of regular use on sensations elicited by electrical stimulation. We anticipate that regular stimulation that is associated with prosthetic hand use may improve the quality and usefulness of the sensations and may alter the userÕs perception of the phantom hand. These investigations with the initial two subjects in this first-in-human clinical trial will inform future developments of the system and may suggest modifications to the procedures for system deployment and assessment in larger clinical trials.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Apr 01, 2019
- Source ID
- W911NF1710022
Entities
People
- Ranu Jung
Organizations
- Army Contracting Command
- Defense Advanced Research Projects Agency
- Florida International University