Florida International University (FIU) researchers have received an investigational device exemption from the U.S. Food and Drug Administration (FDA) to conduct the first-in-human trial of an advanced upper-limb prosthetic system that is designed to restore sensation. The system was developed at FIU by Ranu Jung, PhD, interim dean of the College of Engineering and Computing and a Wallace H. Coulter Eminent Scholars Chair in biomedical engineering, and her Adaptive Neural Systems Laboratory team. The work reflects an almost decade-long collaborative team effort.
“The system is intended to restore the sense of touch and hand opening, which would allow users to precisely differentiate the size and fragility of various objects,” said Jung.
Jung’s technology, a neural-enabled prosthetic hand system (NEPH), delivers electrical pulses that stimulate nerves in the residual limb to provide sensation as the person is using the prosthetic hand. The prosthetic system has the first fully implantable, wirelessly controlled Class III device with electrodes that can be surgically implanted within the nerves. Wires as thin as a hair strand are placed within nerve bundles in the arm and connected to an electrical stimulator. Sensors embedded in the prosthetic hand send signals wirelessly to the implanted stimulator, which then elicits sensation by delivering weak electrical pulses via the implanted electrodes. Thus, the person should be able to sense the hand opening position and grip items when the prosthetic hand encounters an object.
Trial participants will be able to use the system outside of the laboratory, and researchers will be able to assess the long-term clinical impact of its use in real-world environments, said Jung. The NEPH system is not approved by the FDA for U.S. commercial distribution, but if the trial is successful, Jung and her team plan to continue testing through larger clinical trials and eventually seek such approval.
The system may interface with several different advanced prosthetic hands that are currently being developed commercially or under government support. The trial is being supported by the Hand Proprioception and Touch Interfaces (HAPTIX) program of the Defense Advanced Research Projects Agency (DARPA). FIU, with Jung as principal investigator, will receive up to $2.2 million in support.
The system and studies have been developed in collaboration with James Abbas, PhD, a professor at the School of Biological and Health Systems Engineering at Arizona State University. Industry partners include Cochlear, Sydney, Australia; Motion Control, Salt Lake City, Utah; Nikao, Weston, Florida; and clinical teams from the Miami Hand & Upper Extremity Institute, Florida, and Ortho Pro Associates, Miami.
Editor’s note: This story was adapted from materials provided by FIU.