A collaborative effort between the University of Louisville and Medtronic to apply epidural stimulation therapy to those with spinal cord injury has been given a boost thanks to a US$7.8 million grant from the National Institute of Neurological Disorders and Stroke.
Researchers at the university made global news back in 2018 when two people diagnosed with complete spinal cord injuries recovered the ability to walk thanks to experimental use epidural stimulation.
However, despite these results, use of epidural stimulation outside a research lab setting to restore function for people with spinal cord injury has thus far has been hampered by a myriad of limitations, including the use of a technology that was designed for patients with chronic, intractable pain—not those with spinal cord injury.
The recently announced $7.8 million from the National Institute of Neurological Disorders and Stroke—one of the National Institutes of Health (NIH)— will fund work at UofL’s Kentucky Spinal Cord Injury Research Center (KSCIRC) in collaboration with Medtronic to develop and test software applications specifically designed for spinal cord injury that work in concert with Medtronic’s commercially-available device, Intellis, which is indicated as a spinal cord stimulator for chronic pain.
The five-year project, funded through the NIH BRAIN Initiative, is focused on incorporating technology to improve control of locomotor and bladder function using epidural stimulation.
Claudia Angeli, director of the Epidural Stimulation Program at KSCIRC, said: “We have seen excellent results with epidural stimulation in the lab, but these enhancements to the technology system will make it much easier to implement this therapy out in the community.
“Integrating multiple systems will allow people with chronic spinal cord injuries to benefit from stimulation on a daily basis by reducing the need to monitor and manually revise stimulation settings.”
Medtronic epidural stimulators were first used for spinal cord injury in 2009 under an investigational device exemption with the FDA during research at UofL led by Susan Harkema, professor of neurological surgery and associate scientific director for KSCIRC. The epidural stimulation therapy involves implanting a neurostimulator under the patients’ skin and implanting electrodes in the epidural space of the lower spinal cord, which together deliver mild electrical impulses to the spine.
While epidural stimulation has been proven to provide effective relief for chronic pain, there are limitations in functionality when treating individuals with spinal cord injury. For example, the stimulation settings that allow individuals with spinal cord injury to stand are different from settings that allow them to walk, while a third configuration is required to help with bladder function. Additionally, the devices that researchers use today must be programmed manually for each individual function.
The goal of the new project is to develop integrated, closed-loop programming for multiple systems, specifically locomotion and bladder function, using wireless sensors to monitor the user’s condition and adjust stimulator settings as needed. Working with Medtronic, the UofL researchers will develop learning programs for the closed-loop system and integrate the programming with commercially available epidural stimulators, as an investigational use.
Charlie Covert, vice president and general manager of Pain Therapies, part of the Neuromodulation Operating Unit at Medtronic, added: “Medtronic is excited to be collaborating with the University of Louisville on research related to the use of spinal cord stimulation to improve function for individuals with spinal cord injury.
“Collaboration is vital to innovation in this space in order to meet the needs of this important patient population.”