July 10, 2020. The University of Utah received FDA approval for an Early Feasibility Study Investigational Device Exemption (EFS-IDE) study to test an advanced neuroprosthetic arm system in humans in a take-home trial. The study is part of the Defense Advanced Research Project Agency’s (DARPA’s) Hand Proprioception and Touch Interface (HAPTIX) program.
The University’s role is to attach the subject’s arm nerves and muscles to an advanced, sensorized dexterous prosthetic arm, Luke-Skywalker style, after hand amputation. The team is studying if this allows participants to move the hand in more complex patterns in a more natural and intuitive way, just by thinking about it. In the other direction, the user can also receive biologically realistic feelings of touch and movement back from the arm—ideally helping the volunteers feel whole again, and to improve their ability to perform dexterous tasks with the prosthetic arm.
FDA EFS-IDE approval includes use of the implanted 100-electrode Utah Slanted Electrode Array (USEA) for highly precise, biomimetic nerve stimulation and recording, which is now made by local neurotechnology company Blackrock Microsystems; implanted custom University-of-Michigan/Synapse-Biomedical electromyographic (EMG) electrodes for recording additional muscle signals from remaining hand muscles in the forearm; the DEKA sensorized, dexterous artificial LUKE arm; and the Nomad portable neural information processor, made by local neurotechnology company Ripple Neuro LLC, which allows bidirectional communication between the neuromuscular implants and the arm.
FDA approval of the EFS-IDE study constitutes a critical regulatory step toward a take-home trial with human subjects, in order to provide new first-in-human demonstrations of the HAPTIX system.
The experimental successes and regulatory approvals associated with the HAPTIX system and associated take-home trials may ultimately facilitate progress and approvals for other potential uses of the neural and muscle implant technologies, the associated hardware and algorithms for the signals, and approaches in the field of translational neural interfaces.
That’s beneficial for the broader scientific and engineering neuroengineering fields, for local neurotechnology companies such as Blackrock and Ripple, and most importantly for development of devices that may be used to treat several conditions involving nervous system damage or disease.
Some of these additional potential translational uses are already being explored experimentally. Examples for USEAs in the peripheral nervous system (PNS) include further advances for prosthetic limbs, including integration with bone-implant systems for better attachment of prostheses; extensions to lower limbs; auditory nerve implants to restore hearing; motor nerve stimulation for reanimating paralyzed limbs after spinal cord injury or stroke, or for bladder control; and mitigation of chronic pain. Because peripheral nerves innervate almost every body part and organ system, there are multiple opportunities to provide clinical benefits for a wide variety of disorders or diseases.
The Ripple Nomad portable information processor also has widespread potential applications. Portability is key to bringing these advanced technologies to usability in the real world so as to improve end-users’ quality of daily living.