Restoring Sensation with a Neural-Enabled Prosthetic Hand System for Daily Use: A Multisite Clinical Trial
Abstract
As we use a hand to manipulate an object, high-quality control is enabled by a multitude of sensors in the skin, muscles, and joints that provide us with the ability to successfully locate the object, pick it up, and manipulate it without ever looking at it. Using the sensory information from the hand, we can easily discern the difference between a paper cup and a ceramic cup or a golf ball and a tennis ball. Today’s motorized upper limb prostheses do not afford high-quality control, in part because the user must rely on visual feedback that does not convey critical information such as contact force and incurs high attentional demands to monitor hand movements. Advances in prosthetic technology have allowed American Veterans and Service members to live more comfortable lives; however, there is still high incidence of dissatisfaction and prosthesis abandonment. Prior work by our group and others has shown that electrical stimulation delivered by electrodes implanted in or near nerves in the remaining portion of the limb can elicit sensations that the individual perceives as coming from the missing hand. If the electrical stimulation is driven by information derived from sensors in the prosthetic hand, the user would receive task-related sensations that may increase their proficiency in performing tasks and therefore may allow them to participate in a greater range of Service-related, employment, and leisure activities. We have developed the Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system, which uses signals derived from sensors on the prosthetic hand to elicit sensations by delivering stimulation via fine wires implanted in nerves of the residual limb. External electronics embedded in the prosthesis frame send stimulation commands across the skin using a wireless link to electronics implanted in the arm. The ANS-NEPH system is simple to don/doff and operate. It is lightweight, with its external components all incorporated into the prosthesis, and it is suitable for daily long-term use in real-world environments. We have deployed our system in one individual who is currently using the system at home regularly. By using it on a daily basis, we anticipate that the user may learn to perform new tasks with the prosthesis, perform tasks with more confidence, and/or perform tasks more efficiently. In the proposed trial, we will recruit additional subjects to assess system safety, viability, and the impact of daily system use as they perform activities that matter to them. Specifically, the proposed work seeks to improve the quality of life of wounded Service members who have experienced limb amputation by enhancing their ability to perform duty-related activities, increasing their efficiency in performing routine tasks, and enriching their experience when utilizing prosthetic technology. This work therefore directly addresses the objectives of Joint Program Committee 8: Clinical and Rehabilitative Medicine Research Program (CRMRP) with a focus on Neuromusculoskeletal Injury Rehabilitation. A total of eight subjects with upper-limb amputation will be recruited and enrolled in this multi-site trial: six with amputation on one side at the level of the forearm and two with amputation on both arms but at least one side at the level of the forearm. Subjects will be enrolled at two sites: Florida International University (FIU) and the Uniformed Services University of the Health Sciences (USUHS)/Walter Reed National Military Medical Center (WRNMMC). Each subject will undergo surgery to receive the implanted components of the ANS-NEPH system, get fitted with the external (prosthesis-mounted) components, and participate in an extensive series of experiments over a 2-year period to assess system safety and to address specific research hypotheses. For the individuals who choose to enroll in the study, the primary set of risks would be those associated with implantation and use of a neural stimu
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Nov 19, 2019
- Source ID
- W81XWH1910839
Entities
People
- Ranu Jung
Organizations
- Florida International University
- United States Army