Significant milestones for The Big Idea

Over the past year, the Christopher & Dana Reeve Foundation has shared a cascade of new research on epidural stimulation and its potential life-changing impact for individuals living with chronic, complete spinal cord injury. This includes significant milestones for The Big Idea. We are proud to announce that we are now implanting participants in The Big Idea.

When The Big Idea received unconditional FDA approval, the research team at the University of Louisville began to enroll participants into the study. As of today, seven people have been implanted, including one woman and six men who were injured for 2.5-10-years and ranged in age from 19 to 60 at the time of receiving the device. Another five participants are scheduled for implantation from now through June 2019.

The Big Idea is further investigating the positive effects of epidural stimulation in 36 people with chronic, complete spinal cord injury. The study will explore the application of a continuous electrical current -- at varying frequencies and intensities -- to specific locations on the lower part of the spinal cord. The study requires the implantation of a device over the dura that activates nerve circuits in the spinal cord.

Each participant undergoes a series of experiments following implantation in which data is recorded and analyzed to better understand the full power and potential of this technology. Epidural stimulation continues to expand our knowledge of how individuals who were completely paralyzed for years can recover vital functions once thought to be lost forever.

This new knowledge includes groundbreaking publications unveiled last year that documented how epidural stimulation enabled individuals who were completely paralyzed for years to take steps with limited assistance.

Here is an overview of the 2018 epidural stimulation publications:
Dr. Reggie Edgerton, along with researchers from the Mayo Clinic and UCLA unveiled new research in the scientific journal Nature Medicine. Through the application of epidural stimulation in combination with task-specific training, a young man living with chronic complete paraplegia recovered the ability to step over ground while using a front-wheeled walker with trainers providing only sporadic assistance. Additionally, he was able to take bilateral steps on a treadmill. Not only is this discovery unprecedented, it was deemed impossible only a few years ago by many prominent leaders in the field.

At the same time, Dr. Susan Harkema and Dr. Claudia Angeli at the Kentucky Spinal Cord Injury Research Center at the University of Louisville have published two groundbreaking papers. The New England Journal of Medicine (NEJM) paper details how epidural stimulation can foster greater brain-to-spine connectivity in individuals with chronic complete paralysis. As a result of that connection, two of the four research participants featured in the paper are able to walk over ground with a walker and no physical assistance. In addition, all four participants achieved independent standing and trunk stability while maintaining their mental focus, which is defined as purposefully wanting to pick up their foot or leg to take steps. However, these small steps may very well redefine the recovery expectations following a complete injury.

In addition, the Journal of the American Medical Association (JAMA) reported another four research participants, all living with chronic cervical spinal cord injuries, at the University of Louisville had experienced improved cardiovascular function as a result of epidural stimulation, including blood pressure and heart rate regulation. Cardiovascular dysfunction cannot only diminish quality of life, but it can also be very dangerous and even deadly as people often gasp for air and lose consciousness.

Soon after the publications on stepping were released, a group at the Swiss Federal Institute of Technology published similar results in Nature featuring three young men with incomplete injuries who achieved independent stepping. Having three independent studies achieve stepping and replicate similar outcomes across the SCI patient population is truly groundbreaking.

The Big Idea dives deeper into our understanding of epidural stimulation, testing this potential therapy on a larger, more diverse patient group with the hope of fast-tracking this technology to the clinic.

Potential research participants have been identified from the University of Louisville's Victory Over Paralysis research database. The process to identify and enroll a participant into The Big Idea is (1) pre-screening; (2) screening; (3) consenting into usual care; (4) pre-implant assessments; (5) consenting into the study, followed by implantation. As this process continues, those candidates completing usual care will return to the University of Louisville for pre-implant assessments, final consent into the study, and implantation.

Progress in research comes with a tremendous cost, especially when entering human trials and advancing scientific findings from the lab to the community. That is why we are incredibly grateful for our global network of supporters for their continued generosity and advocacy as we work to usher this remarkable therapy from bench to bedside.

We have entered a new era of innovation in which no one questions if cures for spinal cord injury exist, it is simply a matter of how fast we can get them to our community. It is our hope, starting with The Big Idea, that we will advance epidural stimulation to the forefront of care as the first standard treatment option for chronic spinal cord injury

Together, let's get The Big Idea to the finish line.

Peter T. Wilderotter
President and CEO
Christopher & Dana Reeve Foundation