Epidural Stimulation for SCI receives major clearance from FDA

We wrote about this earlier this summer and just this past week, the Reeve Foundation, the major sponsor of the Epidural Stimulation for Spinal Cord Injury, announced that the FDA has now approved the feasibility study involving this innovative research.

download.png

Researcher will measure the extent to which epidural stimulation will facilitate the ability to stand and voluntarily control leg movements below the injury level, and will improve cardiovascular function in 36 chronic, complete participants.  This work was commonly referred to as The Big Idea project.  In the initial study back in 2014, 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 Reeve Foundation has developed a great Q&A section addressing the various questions one might have about this research work.  CLICK HERE.

Researchers are now 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.

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.