A collaborative effort between the University of Louisville and Medtronic to apply epidural stimulation therapy to people with spinal cord injuries was spurred by a $ 7.8 million grant from the National Institute of Neurological Disorders and Stroke .
University researchers made world news in 2018 when two people diagnosed with complete spinal cord injury regained the ability to walk through epidural stimulation for experimental use.
However, despite these findings, the use of epidural stimulation outside of a research lab to restore function in people with spinal cord injury has so far been hampered by a myriad of limitations, including the use of a technology designed for patients with intractable pain — not those with a spinal cord injury.
The $ 7.8 million recently announced by the National Institute of Neurological Disorders and Stroke – one of the National Institutes of Health (NIH) – will fund work at the Kentucky Spinal Cord Injury Research Center (KSCIRC) at UofL in collaboration with Medtronic to develop and test software applications. specially designed for spinal cord injuries that work in conjunction with Medtronic’s commercially available device, Intellis, which is indicated as a spinal cord stimulator for chronic pain.
The five-year project, funded by the NIH BRAIN initiative, focuses on integrating technology to improve control of locomotor and bladder function using epidural stimulation.
Claudia Angeli, Epidural Stimulation Program Director at KSCIRC, said: “We have seen great results with epidural stimulation in the laboratory, but these technological system improvements will greatly facilitate the implementation of this therapy in the community.
“The integration of multiple systems will allow people with chronic spinal cord injury to benefit from daily stimulation by reducing the need to manually monitor and revise stimulation parameters.”
Medtronic epidural stimulators were first used for spinal cord injury in 2009 as part of an investigational device exemption with the FDA in research at UofL led by Susan Harkema, professor of surgery neurologist and associate scientific director of KSCIRC. Epidural stimulation therapy involves implanting a neurostimulator under the skin of patients and implanting electrodes into the epidural space of the lower spinal cord, which together deliver mild electrical impulses to the spine.
Although epidural stimulation has been proven to provide effective relief from chronic pain, there are functionality limitations when treating people with spinal cord injury. For example, the stimulation settings that allow people with a spinal cord injury to stand are different from the settings that allow them to walk, while a third set-up is needed to help bladder function. In addition, the devices researchers use today must be manually programmed for each individual function.
The goal of the new project is to develop integrated closed-loop programming for multiple systems, particularly locomotion and bladder function, using wireless sensors to monitor user condition and adjust pacemaker parameters according to needs. In collaboration with Medtronic, researchers at UofL will develop learning programs for the closed-loop system and integrate programming with commercially available epidural stimulators, on an experimental basis.
Charlie Covert, vice president and general manager of Pain Therapies, which is part of Medtronic’s neuromodulation business unit, added, “Medtronic is delighted to collaborate with the University of Louisville on research related to the use of stimulation of the spinal cord to improve the function of individuals. with a spinal cord injury.
“Collaboration is key to innovation in this space in order to meet the needs of this large patient population. “