12 Feb FDA Approves Epidural Stimulation Research to be Conducted by University of Louisville
Epidural Stimulation has finally received an approval for testing from the United States Food and Drug Administration. Towards the end of December 2017, the USFDA granted the request of the University of Louisville Kentucky School of Medicine to begin enrollment of participants for a clinical study on Epidural Stimulation’s effects on Spinal Cord Injury (SCI).
For the longest time, Epidural Stimulation has remained on the fringes of conventional medical practice. Its use as a form of Spinal Cord Injury Treatment has grown in recent years. However, it has generally remained outside the realm of conventional medicine as the treatments have yet to be significantly studied by the medical community. This new study may be the first step towards the mainstream application of the treatment.
The University of Louisville Study
The research team, led by Dr. Susan Harkema from U of L’s Kentucky Spinal Cord Injury Research Center will be conducting the study on 36 individuals with chronic, complete paralysis. They intend to measure just how much epidural stimulation is able to facilitate the ability of an SCI patient to regain voluntary leg movement past the point of injury.
Through this neuroscience research, Dr. Harkema’s team is intending to scientifically demonstrate the efficacy and safety of the procedure as a method of treatment for Spinal Cord Injury. The long-term goal is also to make this treatment available to as many individuals who can benefit from it as soon as possible.
Harkema has already previously conducted several earlier studies on Epidural Stimulation. Those initial studies have led her to believe in the potential of Epidural Stimulation as a treatment for paralysis. Some individuals have been able to regain sensation in areas previously affected by Spinal Cord Injury. A number have also been able to stand as well as have regained the ability to control lower-body movement. These patients were also able to improve their cardiovascular fitness and achieve blood pressure levels that are closer to normal.
This study will attempt to recreate the successful applications of epidural stimulation on a much larger sample size. By doing this, researchers will be able to better analyse the numerous variables that relate to the effectiveness of the treatment as well as its limitations.
At present, the researchers are screening potential candidates. The study will proceed over a period of six years. Each individual participant will take part in the study for a period of two years. For interested parties, more information and application details can be found in the Victory Over Paralysis Database of the University.
Dr. Harkema and her team are part of the Kentucky Spinal Cord Injury Research Center at U of L. This facility opened in the year 2001 and has since provided physical therapists, scientists, neurosurgeons, and physicians a venue to come together and work towards the goal of better understanding and eventually curing paralysis.
The Big Idea
In order to fund this research, the proponents secured a grant from the Christopher & Dana Reeve Foundation. The organisation, for several decades, has been actively supporting innovative research for Spinal Cord Injury. Its recent efforts have shifted towards attaining a better understanding of Epidural Stimulation.
The Christopher & Dana Reeve Foundation is funding this research as a follow through on the Epidural Stimulation research funded by the organisation in 2014. The results of that earlier study were published in Brain, a peer-reviewed, scientific journal on neurology. That study introduced an electrical stimulator onto the spines of four men diagnosed with chronic, complete spinal injuries. These four individuals were able to regain control of their legs, ability to stand, as well as flex various muscles on their lower body. The patients also demonstrated improvements in their autonomic functions such as their bladder and bowel movements, as well as sexual function.
The positive results of the first study have led to the organization’s current campaign, “The Big Idea”. For the first time, the medical community glimpsed on the possibility of a significant enhancement in the health and quality of life of individuals diagnosed with complete paralysis. Reeve Foundation President and CEO, Peter Wilderotter, is optimistic about the participant enrollment. He believes that this study brings us closer to the effective transformation of many lives that were affected negatively by Spinal Cord Injuries. This study will give hope to many who have been told that recovery from complete Spinal Cord Injury isn’t possible. Walking after Spinal Cord Injury should be a real possibility.
Epidural Stimulation Procedure with Unique Access Medical
We Know It Works!
The envisioned benefits that this study seeks to explore are regularly experienced by patients who receive the Epidural Stimulation implant with Unique Access Medical (UAM). In fact, we have treated more than 25+ so far (January 2018) and intend to treat nearly 100 patients until the end of the year. We are preparing to release our medical follow up data in the coming months.
We know it is safe, and effective. While others are busy with case studies we have made this treatment available today in Bangkok, Thailand.
With the advancement of medicine and the continued research into Epidural Stimulation, chronic complete paralysis is approaching a universally-accepted treatment protocol.
We applaud the initiative and hope for a positive conclusion of the FDA study in the year 2025 (!) until then UAM remains the best and only place to get the Epidural Stimulation Procedure. For more information about the treatment plan, please contact us and a Patient Representative will get back to you at your earliest convenience.