A new, first-of-its-kind clinical trial will examine how the brain adapts to advanced, bionic arms in children born without a limb, with the ultimate goal of improving children’s control of their prosthetic.

The work, which starts this spring, will be led by Limbitless Solutions, a nonprofit, direct support organization at the University of Central Florida, Wolfson Children’s Hospital of Jacksonville and Nemours Children’s Health, Jacksonville. The joint effort brings together expertise from pediatric research, neuroradiology, and bionics.

Approximately four babies in every 10,000 are born missing a limb, according to the U.S. Centers for Disease Control and Prevention. Prosthetics can be a supportive tool for children to perform everyday activities, but little is known about how the brain responds to the addition of an artificial limb.

“Limited research has been conducted on how the brain’s motor cortex structure changes from congenital limb loss and subsequent use of a prosthetic,” says Albert Manero, ’12 ’14MS ’16PhD, executive director and co-founder of Limbitless Solutions.

The four-month clinical trial will examine if Limbitless’ prosthetic — paired with its custom training video game — will impact the motor control center of the brain. Researchers will closely monitor any changes in the signals the brain sends to the muscle groups that direct the bionics’ movement.

They will do this using advanced functional magnetic resonance imaging techniques before and after prosthetic use and training. Additionally, researchers will use a method known as tractography — where MRI scans visualize the nerve pathways — to identify new or more robust pathways resulting from the training.

The study is unique because it combines advanced imaging techniques with novel prosthetics and video-game-based training to evaluate motor cortex engagement.

“It may provide new insight to how the brain’s motor cortex adapts to learning how to use our organic, or robotic, limbs,” Manero says.

Manero will lead the research study on the Limbitless side as the investigator along with other UCF staff and faculty. Chetan Shah, chair of radiology at Nemours Children’s Health, Jacksonville, Florida, and based at Wolfson Children’s Hospital of Jacksonville, will lead the imaging work.

“This research will help us see how the brain responds to the child’s newly acquired ability to use a prosthetic hand,” Dr. Shah says. “This is a novel way of using existing brain circuits to use an artificial limb, and most importantly, this is a life-changing device for a child both mentally and physically. We are extremely enthusiastic about this research.”

Limbitless Solutions, which Manero co-founded as a graduate student at UCF along with John Sparkman ’13 ’15MS and Dominique Courbin ’18, specializes in developing advanced, muscle-based biosensing technology, such as bionic limbs, to increase accessibility and empower children and adults in the limb-different community.

The customized prosthetics they create are 3D printed and can be paired with a parent’s smart phone. The devices even charge like a cell phone, via USB type C.

The exteriors of the devices are artistically designed and customized, with input from each participant. Existing muscles in the residual part of a limb are used to control their function, which is triggered by a person’s own muscle flex.

In 2016, Limbitless and faculty members Matt Dombrowski ’08MFA with UCF’s School of Visual Arts and Design and Peter Smith ’05MS ’12PhD with UCF’s Nicholson School of Communication and Media created video games to train children’s muscles in anticipation of receiving bionic arms. These video games will be leveraged in the trial to support training for the use of the prosthetic limb.

Limbitless Solutions believes no person with a limb difference should be financially burdened to have a bionic arm and plans to provide prosthetics and training systems for the study free of charge.

To learn more about the program and to submit an application to receive information about the study, families are asked to apply here: trials.limbitless-solutions.org. The study is for children ages 9 to 12, and a maximum of five patients will be enrolled in the pilot study.

About Limbitless Solutions

Limbitless Solutions is a nonprofit and direct support organization at UCF dedicated to increasing accessibility and empowering children and adults in the limb difference community. Through personalized, creative, and expressive bionics, provided without financial burden, the team aims to empower using innovative technology and interdisciplinary collaboration to address accessibility issues. Limbitless develops muscle-based biosensing technology including multi-gesture bionic arms, a hands-free wheelchair control device and interactive video game training.

Founded in 2014, and located in UCF’s Research Park in Orlando, Florida, Limbitless combines engineering and art to promote access and engagement in STEAM learning experiences for a more inclusive future. Undergraduate students from various academic perspectives engage in project-based learning, professional development and research experiences where students put academics into practice in an environment focused on making a difference, as well as professional and technical development.

Previous clinical trials of Limbitless Solutions technology have included examining the functionality of the bionic arms and their effect on quality of life, the effectiveness of video-game-based training, and the ability of a hands-free wheelchair control device to improve independent mobility and quality of life.

Manero received his doctoral degree in mechanical engineering and his master’s and bachelor’s degrees in aerospace engineering from UCF. He joined UCF’s Office of Research in 2017, and holds courtesy research appointments in UCF’s Mechanical and Aerospace Engineering Department in the College of Engineering and Computer Science, Mayo Clinic’s Neurology department, and Veterans Affairs Orlando Healthcare System. He is also a member of UCF’s Biionix research cluster.

About Wolfson Children’s Hospital of Jacksonville

Wolfson Children’s Hospital in Jacksonville, Florida, is a part of Baptist Health, Northeast Florida’s most comprehensive health system serving every stage of life. Wolfson Children’s is the only children’s hospital in Northeast Florida and serves as the pediatric referral center for North Florida, South Georgia and beyond. Staffed 24/7 by pediatric nurses and other healthcare professionals specially trained to work with children, the 216-bed, patient- and family-centered hospital features the latest pediatric medical technology in a welcoming, child-friendly environment. At Wolfson Children’s, nationally recognized pediatric specialists representing nearly every medical and surgical specialty work with pediatricians to provide care for children of all ages with congenital heart conditions, cancer, neurological disorders, diabetes and endocrinology disorders, orthopedic conditions, behavioral health conditions, traumatic injuries, and more. Wolfson Children’s pediatric institutional partners include Nemours Children’s Specialty Care, Jacksonville, UPMC Children’s Hospital of Pittsburgh, the University of Florida College of Medicine — Jacksonville and Mayo Clinic Florida. A Magnet-designated hospital since 2010, Wolfson Children’s Hospital has been named among the U.S. News & World Report 50 Best Children’s Hospitals year after year, and in 2021, was selected as one of only eight children’s hospitals in the country as a Leapfrog Top Children’s Hospital, a recognition of patient quality and safety. For additional information, please visit wolfsonchildrens.com.