At age 16, Alexander “Avi” Davidson fell 35 feet from the top of a telephone pole, an accident that left him paralyzed from the waist down and led to the amputation of his left arm below the elbow. Today, 17 years later, Davidson is taking part in a first-of-its-kind clinical trial as the inaugural participant to use the Luke Skywalker-inspired bionic arm developed at the University of Utah.
Powered by a direct nerve interface, called the BIOS Controller, the neural interface technology allows Davidson to control the bionic prosthesis with his thoughts while restoring a sense of touch so that it feels similar to using his own hand. Within days of using it at home, he was able to carry out routine tasks that many take for granted, from writing and playing cards to making a tuna sandwich and holding his wife’s hand.
“The ability to have a return of sensation to my previously dominant hand is a life-altering experience, as I never imagined feeling any part of that hand in my lifetime, let alone for it to feel so authentic,” said Davidson, who lives in Tampa, Florida. “The ability to recognize how much pressure I’m putting on my wife’s hand and to feel hers back in mine is a wild idea to internalize. This technology has the potential to reconnect so many individuals to a reality they did not believe possible.”
The trial will follow Davidson as he uses the technology at home for one year, with the possibility of an extension. It will provide a rare look at whether nerve-connected prosthetic technology enhances daily life for people with limb loss. Davidson is documenting the journey on his Instagram.
Davidson is a therapist, photographer, activist and husband with an interest in technology. He has tested other robotic prosthetics but says that none have the range of movement, fine control, sensory feedback and ease of use that the thought-controlled prosthetic has.
Clinical trial participants are experiencing the world in a whole new way that really shapes and encourages our research and development and inspires us to keep working on this technology, The goal is to ultimately transform the standard of life and quality of care for individuals with limb loss.”
Jacob A. George, Director, NeuroRobotics Lab, University of Utah
From science fiction to reality
Robotic prosthetics have long been a science-fiction staple, but their real-world counterparts have yet to live up to those promises. Despite recent technological advances, many amputees still prefer a Civil War-era technology–body-powered hooks–owing to robotic arms’ cumbersome controls.
Direct nerve interfaces are poised to fundamentally change this dynamic. With such a device implanted in the residual limb, a user can control a “neuroprosthetic” arm with their thoughts. What’s more, the interface can send information from the robotic limb to the user’s brain, restoring a sense of touch.
“Because of the presence of sensation, it allows that access to do more things in a different context that wouldn’t be possible with other prosthetic devices,” said Leanne Seckinger, an occupational therapist at University of Utah Health who has been helping Davidson integrate his use of the neuroprosthesis into daily life.
George has been developing Utah’s Skywalker-style bionic arm since 2015. Based on the LUKE Arm, a commercially available advanced robotic prosthesis made by DEKA, the Utah arm incorporates the BIOS direct nerve interface to make it a true neuroprosthesis. Now, for the first time as part of the clinical trial, Davidson is using it in his own home.
A partnership with spin-out Biologic Input Output Systems (BIOS) is supporting the U’s ongoing Investigational Device Exception Early Feasibility Study, allowing for the recruitment of this participant.
Research moves outside the lab
The U’s research team is led by George, the Solzbacher-Chen Endowed Professor in the John and Marcia Price College of Engineering’s Department of Electrical & Computer Engineering and the Spencer Fox Eccles School of Medicine’s Department of Physical Medicine & Rehabilitation and Marshall Trout, a researcher in his lab and a OneU Responsible AI Initiative postdoctoral fellow at the U’s Scientific Computing and Imaging Institute. George also serves as chief scientist for BIOS. In 2022, BIOS executed a licensing agreement with the University of Utah for the technology behind the neuroprosthesis and continues to evolve the technology toward commercialization.
Davidson is the ninth participant to be involved in this type of research at the University of Utah. Prior participants were under the supervision of Gregory Clark, professor emeritus in biomedical engineering, and Douglas Hutchinson, orthopedic professor and surgeon. Under Clark and Hutchinson, and with support from the Defense Advanced Research Projects Agency and the National Science Foundation, the patients helped test the interface’s increasing array of capabilities, including the ability to provide bionic arm users with a sense of touch. Until now, testing has remained largely limited to laboratory settings.
The overwhelmingly positive results of this technology to date earned the BIOS direct nerve interface a Breakthrough Devices Program designation from the FDA in March 2024, as well as admission into its Total Product Lifecycle Advisory Program. The FDA uses these programs to fast-track promising experimental medical devices toward everyday use.
Each of the previous patients used the device under the supervision of engineers and clinicians on the University of Utah’s campus. But the latest iteration of the technology’s software and AI allows for more life-like sensation, increased dexterity and more intuitive control, making unsupervised, everyday use feasible for the first time. The home trial explores how well the neuroprosthetic meets the demands of daily life and whether it is useful and intuitive enough for participants to want to keep using it long term.
The BIOS direct nerve interface can also be integrated with other technology, like other robots, virtual reality systems or phones/computers, so that individuals can seamlessly control and feel from their devices with just their thoughts.
“The possibilities truly are endless,” George said. “With this technology, we can create an inclusive world for everyone, regardless of their physical capabilities.”
Sept. 18 press conference announcing a clinical trial for the first in-home use of the Luke arm. Video Credit: University of Utah
This article was originally published on news-medical