FDA Approves Study of Efficacy of Epidural Stimulation Treatment on Spinal Cord Injuries

The University of Louisville School of Medicine received exciting news this past December that the FDA had approved its plans to formally study a groundbreaking spinal cord injury treatment called Epidural Stimulation.

The university is currently looking for 36 participants who have suffered paralysis due to a spinal cord injury (SCI). They will conduct a feasibility study intended to determine the life-enhancing results epidural stimulation has on individuals suffering from SCI.

The potential impact of the study, especially if it proves epidural stimulation to be a successful and safe treatment, is enormous.

What Is Epidural Stimulation?

Epidural Stimulation is an innovative spinal cord injury treatment that uses a surgically implanted device to connect with and stimulate the nerve system through electrical current. The device has two parts: a neuro-stimulator (the power source) and a lead (a set of electrodes) that sits over the posterior portion of the lumbar spine.  

The epidural stimulator, when activated, delivers continual electrical current to the spinal cord, stimulating locomotor-like activity. As the nerve system is stimulated, the body begins to re-learn feeling, sensation, and movement.

Once implanted, the device is controlled by a remote. A highly experienced therapist uses the remote during the 30-40-day rehabilitation process to “map” the patient’s movements in response to the stimulation and helps the patient, their brain, nerves, and muscles relearn how to move voluntarily.

The treatment can be used on patients suffering both complete and incomplete spinal cord injuries.

Where Has It Been Practiced Before?

Epidural Stimulation is a relatively new and groundbreaking treatment. 

Patients have literally traveled the world to get access to the treatment. Now that the FDA has approved a formal medical study of significant size to put the treatment to the test, there is hope that in the United States, the treatment may become a recognised as a standard clinical treatment option. This would make Epidural Stimulation a much more accessible and, eventually, affordable treatment option to pursue.

What Will the Testing Accomplish?

With the treatment gaining recognition abroad, and with the support of the Christopher and Dana Reeve Foundation, the Kentucky Spinal Cord Injury Research Center at the University of Louisville School of Medicine has taken on the task of testing the efficacy and safety of this revolutionary spinal cord injury treatment.  

The goal of the study is to definitively demonstrate the effectiveness and validity of epidural stimulation as a clinical treatment. If that can be done, the treatment will become more widely available in the States.

The reason they have chosen to work with participants suffering the most severe form of spinal cord injuries – paralysis – is based on the assumption that if they can help those with the most severe damage, they will certainly be able to help those with lesser spinal cord damage.

The specific goals of the study are to see whether, and to what degree, epidural stimulation can enable patients to:

• Voluntarily control leg movements below the point of injury
• Stand on their own
• Improve cardiovascular function
• Improve blood pressure

It will be the largest and most significant study performed on epidural stimulation in the world. The study will run for a six-year period, with each participant enrolling for two years. The hope is to sufficiently prove the efficacy and safety of epidural stimulation as a legitimate treatment for spinal cord injuries.

This undertaking by the University of Louisville School of Medicine will play a major role in determining the future of the treatment and whether or not it becomes a standard treatment option in the long run. If successful, the study could significantly expedite the availability of the treatment to those who need it most.

More About the Study

The new study is being financed by the Christopher & Dana Reeve Foundation as a part of it’s the Big Idea campaign. The foundation was inspired to fund this study after groundbreaking success in a much smaller study they funded, which was published in 2014.

In that study, epidural stimulation was tested on only four men diagnosed with total spinal cord injuries, but each participant saw significant improvement, including gaining the capability to stand, flex their hips, legs, and toes, and improved ability to control their bowel, bladder and sexual function.

After such encouraging success for patients suffering the most sever forms of spinal cord injuries, the foundation was eager to support a study taking the testing to the next level.

Successes with Epidural Stimulation

Besides the success and hints of great potential that the Christopher & Dana Reeve Foundation witnessed through the 2014 study, epidural stimulation has earned a legitimate track record of success abroad.

Unique Access Medical, a private medical institution in Asia facilitating access to progressive healthcare methods, has helped numerous spinal cord injury patients to be able to receive this breakthrough treatment. They have seen many success stories, including the world’s very first T5 SCI patient to take steps after suffering paralysis.

One of the first patients to receive the treatment, Andrew Bell, suffered complete paralysis from the waist down after a motorcycle accident. Refusing to accept the prognosis that he would never walk again, Andrew did his research and discovered Epidural Stimulation. He traveled to Unique Access Medical and after the initial implant of the stimulator and first round of therapy, he saw more progress than was ever expected.

Those suffering from spinal cord injuries across the globe should know that this groundbreaking treatment is available now. The progress being made in the U.S., as indicated by the FDA’s recent approval of the University of Louisville study, is exciting to see and brings hope that soon this revolutionary treatment will be more accessible. But if you have been waiting long enough, check out Andrew Bell and other patients’ stories out to learn more about what you can do to get on the road to recovery from your injury.