Next Generation Treatments
FDA Pre-Approved Trials
Research and Studies
The United States Food and Drug Administration (USFDA) has approved the University of Louisville Kentucky School of Medicine (U of L) to study the effect of Epidural Stimulation on 36 Spinal Cord Injury patients. This clinical study is led by Dr. Susan Harkema from the university’s Spinal Cord Injury Research Center.
The University of British Columbia’s research team has documented positive results seen in Isaac Darrel, (Canadian C7 Spinal Cord Injury patient) who received Epidural Stimulation with Unique Access Medical. This study was led by Dr. Andrei Krassioukov who is the Chair of Autonomic Standards Committee for the American Spinal Injury Association (ASIA) and the International Spinal Cord Society (ISCoS).
JAMA Neurology (an online medical journal run by the American Medical Association), published the treatment result of the Epidural Stimulation Procedure recently. This study is one of the first to demonstrate the cardiovascular benefits gained from Epidural Stimulation for Spinal Cord Injury patients.
JAMA Neurology (an online medical journal run by the American Medical Association), published the treatment result of the Epidural Stimulation Procedure recently. This study is one of the first to demonstrate the cardiovascular benefits gained from Epidural Stimulation for Spinal Cord Injury patients. The Lancet medical journal published the effect of Epidural Stimulation on voluntary movement, standing and assisted stepping for paraplegic patients. This study was led by Susan Harkema from the University of Louisville.
University of California Los Angeles (UCLA)-led team of scientists managed an Epidural Stimulation procedure that yielded substantial improvements to six Spinal Cord Injury patients. The improvements seen are not only limited to regaining voluntary movements, but also in blood pressure, bladder function, and cardiovascular function. This research was conducted by Dr. V. Reggie Edgerton, a distinguished professor at UCLA since 1968, and his team.
Researchers at the University of Minnesota Neurosurgery Department’s E-STAND Program (Epidural-Stimulation After Neurologic Damage) has successfully implanted Epidural Stimulation in six patients. As one of the members of the team, Ann Parr MD. PhD., an expert in Spinal Cord Injury Research, believes this study has the potential to be groundbreaking.
The Origin of
In 2014 a fascinating study was published in “Brain-Journal of Neurology.” The study written by Claudia A. Angeli, V. Reggie Edgerton, Yury P. Gerasimenko and Susan J. Harkema demonstrates the ability of four individuals with chronic complete paralysis to execute voluntary tasks with a selectivity of appropriate motor pools in the presence of Epidural Stimulation. In three of four individuals, they observed the recovery of voluntary movement with Epidural Stimulation soon after implantation, two of whom had complete loss of both motor and sensory function. This shows that by neuromodulating the spinal circuitry at sub-threshold motor levels with epidural stimulation, chronically complete paralysed individuals can process conceptual, auditory, and visual input to regain specific voluntary control of paralysed muscles. The team has uncovered a fundamentally new intervention strategy that can dramatically affect recovery of voluntary movement in individuals with complete paralysis even years after injury. An epidural spinal cord stimulation unit (Medtronics, RestoreAdvanced) and a 16-electrode array was implanted at vertebrae T11-T12 over spinal cord segments L1-S1 in four individuals with motor complete spinal cord injury. Four individuals diagnosed with clinically motor complete paralysis and implanted with an epidural stimulator at least 2.2 years post injury were able to execute intentional movements of the legs in response to verbal command.