Researchers at the University of Louisville made news around the world in 2018 when two people diagnosed with total spinal injuries were able to walk thanks to an experimental practice called epidural stimulation. The news gave hope to people living with total spinal injuries, a diagnosis that historically meant they were unlikely to regain activity below their injury level.
Despite these important findings, the use of epidural stimulation outside of a research laboratory setting to restore function in people with spinal cord injuries has so far been hampered by a number of limitations, introducing the use of technology designed for patients with chronic, intractable pain – not those with spinal injuries.
Applying this treatment for a spinal injury is a step closer to being used outside of the research lab thanks to a $ 7.8-million grant from the National Institute of Neurological Disorders and Stroke , one of the National Institutes of Health (NIH).
The grant funds work at UofL’s Kentucky Spinal Cord Injury Research Center (KSCIRC) in collaboration with medical device maker Medtronic to develop and test software applications designed specifically for injuries a spinal that works in conjunction with a commercially available Medtronic device, Intellis ™, which is identified as a spinal stimulant device for chronic pain. The five-year project, funded through the NIH BRAIN Initiative, aims to introduce technology to control locomotor and bladder activity using epidural stimulation.
We have seen excellent results with epidural stimulation in the laboratory, but these advances in the technological system make it much easier to implement this treatment in the community. Integrating multiple systems will allow people with spinal cord injuries to benefit from day-to-day stimulation by reducing the need to monitor and review stimulus situations manually. “
Claudia Angeli, Ph.D., Associate Professor of Bioengineering, Jof Speed UofL School of Engineering and Director, KSCIRC Epidural Incentive Program
Angeli and Maxwell Boakye, MD, neurosurgeon and clinical director of KSCIRC, will lead the project.
Medtronic epidural stimulators were first used for spinal cord injuries in 2009 under the FDA-released Research Device during a study at UofL led by Susan Harkema, Ph.D., professor of neurological surgery and co-scientific director -connected for KSCIRC. The epidural stimulation therapy involves the insertion of a neurostimulator under the skin of the patients and the insertion of electrodes into the epidural space of the lower spinal cord, which together deliver movements. calm electricity to the spine.
Although epidural stimulation has been shown to provide effective relief for chronic pain, there are limitations in functionality when treating individuals with spinal injuries. For example, the stimulus options that allow individuals with a spinal injury to stand are different from positions that allow them to walk, while a third adjustment is required to aid bladder function and so on. The tools that researchers use today need to be manually programmed for each individual task.
The aim of the project is to develop integrated, closed-loop programming for multiple systems, especially locomotion and bladder operations, using wireless sensors to monitor the user’s condition and change stimulus positioning 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 a research practice.
“This device will be customized for the needs of individuals with spinal injuries, which require less manual interaction and lead to positive results in locomotion and bladder function, greatly improving time to the advent of neuromodulation for spinal injuries, “said Boakye, head of spinal surgery at UofL School of Medicine, a neurosurgeon with UofL Health – UofL Physicians and a lead neurosurgeon for the device to be inserted.
During the first phase of the study, the researchers will develop learning algorithms and the closed loop system, working with Medtronic’s Intellis Spinal Cord Stimulation (SCS) platform. This level requires that eight individuals receive implanted stimuli and locomotor or bladder interventions to develop learning algorithms, which will later be integrated into closed-loop controls. These data and technical tools are then sent to a second group of eight people who have not received prior training.
“By monitoring multiple systems and enabling the administrator to change incentives without direct input from the user, these enhancements make this tool a powerful tool for development life of people with spinal injuries, “said April Herrity, Ph.D., the researcher on the project.
The 2018 outbreak was the result of years of research by the UofL team, which found that adding electrical stimulation to the lower spinal cord, along with physical therapy, allows for unexpected levels of recovery. the people with total spinal cord injury. Research participants can move voluntarily, stand and take action, as well as experience improvements in blood pressure management, abdominal and bladder function and other common joint health issues. associated with spinal cord injury.
“One of the main obstacles to providing this treatment to patients is the need for special programming for spinal cord injuries,” said Harkema, who is also an investigator of the. this project. “This new work will promote the safe, long-term use of treatment at home and in the community, enabling people with spinal cord injuries to benefit from what we have found over the past two decades. “
“Medtronic is excited to collaborate with the University of Louisville on research related to the use of spinal stimulation to improve function for individuals with spinal cord injuries,” said Charlie Covert, vice president. president and general manager of Pain Therapies, part of the Neuromodulation Operations Unit at Medtronic. “Collaboration is critical to innovation in this area to meet the needs of this important patient population.”