Research Project
10449736
PROJECT SUMMARY There is a large and growing population of individuals with upper-limb amputation whose needs are not fully met by current prosthetic hand technology. Our work is based on the notion that prosthetic hand technology that provides task-related sensations will increase proficiency in sensorimotor tasks and therefore allow prosthesis users to participate in a greater range of employment and leisure activities. To achieve this, the Adaptive Neural Systems neural-enabled prosthetic hand (ANS-NEPH) system was designed and developed by our lab in collaboration with industrial and clinical partners. The system uses a wirelessly-controlled implanted neurostimulator and fine-wire longitudinal intrafascicular electrodes to elicit sensations based on signals derived from sensors in an instrumented prosthetic hand. We have an investigational device exemption from the FDA to conduct a longitudinal first-in-human clinical trial. The first subject has been enrolled, implanted, fitted with the external components of the system, and has completed a 2-year post-implant follow-up period. At the conclusion of his participation in the study, he opted to keep the system and now, more than three years post-implant, he continues to use the system at home and in the community. In the parent grant, we are continuing the trial to evaluate clinical safety and device functionality in additional subjects. The primary outcome of the trial will be a demonstration of clinical feasibility of a neural-enabled prosthetic hand system for daily use (for greater than one year) at home or at the workplace that uses wirelessly-controlled implantable stimulation technology. While creation of the system and the on-going clinical trial constitute significant contributions to the field, the clinical impact will be severely muted if we do not deploy the technology in the clinic and commercialize it. With support from the C3i Accell program, we plan to address two key challenges beyond those being addressed in the parent grant that will enhance the impact by moving this technology towards clinical deployment and commercialization. The first challenge is to develop software that will enable clinicians to program the stimulation settings of the ANS-NEPH system safely, effectively, and efficiently in a clinical setting. We will initiate development of the clinician software to program the ANS-NEPH system by using a structured Human Factors Engineering approach with interviews of representative users and formative evaluations of a mock-up to produce a robust set of use-related requirements for the clinician-user interface. The second challenge is to develop a business model that will enable us to operate effectively in both the neurotechnology and prosthetic limb commercial ecosystems. For this, we will develop plans for a business framework that will enable successful commercialization. This will include preparation of strategies for regulatory pre-market approval by the FDA and for reimbursement during the pivotal clinical trial and after commercialization. By addressing these challenges, we anticipate that we can greatly increase the likelihood of successful commercialization and thereby amplify the clinical impact of the parent grant and other federal support for this research program.
