Caution: The possible dangers of offshore epidural stimulation treatments

Posted by Reeve Staff in Daily Dose on September 27, 2018 # Research

The Christopher & Dana Reeve Foundation is aware that there are companies and clinics in other parts of the world that offer epidural stimulation alone or in combination with other interventions (i.e. stem cell transplants).

Narratives, advertisements and patient testimonials on their websites and across social media channels suggest that their "therapies" are the equivalent of the epidural stimulation studies being done at the University of Louisville, UCLA, the Mayo Clinic, and other reputable research institutions. These medical treatments are not the same and may pose a significant danger to members of our community.

The Reeve-funded studies that have been conducted on epidural stimulation as well as The Big Idea have US Food and Drug Administration (FDA) approval for a very specific research protocol and patient population. The protocol is a rigorously designed study plan that dictates how the research will be conducted from screening participants to collecting and disseminating data.

The Big Idea builds on several decades of peer-reviewed research and will follow a FDA approved protocol in order to meet the safety and effectiveness requirements needed to gain approval for epidural stimulation as a therapy for spinal cord injury.

While the University of Louisville received approval for The Big Idea, epidural stimulation is not FDA-approved as a therapy for spinal cord injury and is still considered experimental. Only after safety and efficacy are rigorously demonstrated will the FDA approve its use for spinal cord injury. That is what the Reeve Foundation and many reputable research partners are working tirelessly to achieve.

Advertisements asking people to pay to be part of an epidural stimulation trial or to have the device implanted are not to be trusted. These offers are saturating the social media space and they are attempting to prey on our community.

Please be safe. Educate yourself on the right questions to ask and gather all of the information you need before committing to any trial or medical procedure.

This statement is intended to clarify what may be confusing or misleading information in the public domain. The Reeve Foundation is committed to conveying accurate information to our community, donors and all interested parties and to ensuring their safety and well-being.