The University of Louisville School of Medicine has received approval from the U.S. Food & Drug Administration to begin enrolling participants in a feasibility study that will further explore the life-enhancing effects of epidural stimulation on people with spinal cord injury (SCI).
The study, funded by the Christopher & Dana Reeve Foundation through its The Big Idea campaign, will measure the extent to which epidural stimulation will improve cardiovascular function as well as facilitate the ability to stand and voluntarily control leg movements below the injury level in 36 chronic, complete participants.
Researchers led by principal investigator Susan Harkema, PhD, associate director of the University of Louisville’s Kentucky Spinal Cord Injury Research Center and professor of neurosurgery, are seeking to demonstrate – using a significant sample size – the safety and efficacy of epidural stimulation as a treatment for SCI, as well as potentially expedite its availability to individuals who can benefit from it.
This research builds on pilot studies funded by the Craig H. Neilsen Foundation showing promising results for using epidural stimulation to improve cardiovascular function in people with SCI. In addition, it continues groundbreaking epidural stimulation research funded by the Reeve Foundation, the Leona M. and Harry B. Helmsley Charitable Trust, the National Institutes of Health and the Kessler Foundation published in 2014 in the scientific journal Brain. In that study, four young men diagnosed with chronic complete spinal cord injury were implanted with a device called an epidural stimulator on their spine. The men regained the ability to stand, bear their weight, and flex their toes, legs and hips. They have also experienced improved autonomic functions, including bladder, bowel and sexual function.
“The discovery that sparked The Big Idea signaled an unprecedented breakthrough in our pursuit to enhance the independence, health and quality of life for people with paralysis,” said Peter Wilderotter, president and CEO of the Reeve Foundation. “With participant enrollment set to begin, we are closer than ever to bringing a therapy that will effectively transform the lives of individuals living with spinal cord injury and give hope to those who were told that recovery was impossible. As Christopher Reeve said, ‘nothing is impossible’ and The Big Idea will prove that.”
The University of Louisville is currently screening potential candidates for the six-year study. Each participant will be enrolled for two years. Those interested in being considered can add their information to the University’s Victory Over Paralysis database, available online.