Transcutaneous Stimulation’s Effect on Chronic Spinal Cord Injury
Article Summary
- University of Miami Miller School of Medicine researchers were part of a study that found chronic spinal cord injury patients benefitted from ARCEX therapy.
- The study compared equivalent rehabilitation sessions for study participants, one with ARCEX therapy and one without.
- The ARCEX sessions greater strength and function improvements in the patients’ hands and arms.
In a large, multicenter study published in Nature Medicine, a research collaboration that included University of Miami Miller School of Medicine researchers found 72% of study participants with chronic spinal cord injury experienced meaningful improvements in arm and hand strength and function when undergoing ARCEX therapy.
ARCEX therapy delivers externally applied electrical stimulation over the cervical spinal cord during structured rehabilitation.
Spinal Cord Injury Study Milestone
“This is one of the first, if not the first, pivotal trial to be conducted in spinal cord injury that was successful in most of the participants,” said principal investigator James Guest, M.D., Ph.D., a professor of neurological surgery at the Miller School. “In this study of 65 spinal cord patients, we met the clinical endpoint that this therapy, transcutaneous cervical stimulation, can move forward for FDA approval of a device. If it’s approved, it can begin to be implemented in clinics in North America and hopefully across the world.”
The study findings are significant because they point to a pathway that leads to better quality of life for patients, according to Dr. Guest.
“When you’re dealing with people who have tetraplegia and quadriplegia, they often are dependent upon others for really simple things, like feeding themselves, pushing a button for an elevator or being able to enter a number on a cell phone,” he said. “The gains that people in the study experienced were relevant to those kinds of daily tasks.”
The Up-LIFT study was a worldwide collaboration of researchers, including Miller School and The Miami Project to Cure Paralysis faculty members, former Miami Project member and current Emory University professor of rehabilitation medicine Edelle Filed Fote, Ph.D., and Leslie R. Morse, D.O., professor and chair of physical medicine and rehabilitation at the Miller School. Dr. Morse was at the University of Minnesota School of Medicine at the time of the trial and served as that site’s principal investigator.
“Congratulations to all the dedicated faculty, staff and trainees that helped make this important trial successful,” said W. Dalton Dietrich, Ph.D., scientific director of The Miami Project and professor of neurological surgery, neurology, biomedical engineering and cell biology at the Miller School. “A special thanks to our Miami Project clinical research team in the Christine E. Lynn Rehabilitation Center, who contributed to the completion of this seminal study and the impressive findings,”
ARCEX Gains Superior to Rehabilitation Alone
Researchers found that the neurological status of patients who underwent ARCEX therapy improved significantly compared to a preceding, equivalent period of rehabilitation that didn’t include ARCEX therapy.
Participants also reported a decrease in the frequency and severity of muscle spasms, improved sleep quality and reduced pain after ARCEX therapy, improvements that translated into notable increases in overall well-being.
The therapy does not require any type of implant.
“You can put electrodes on and have this for an hour, three times a week, and the rest of the time you don’t have to deal with any devices being attached to your body,” Dr. Guest said. “It’s one of those things that centers that specialize in spinal cord injury can scale up, which is an issue that we have in the spinal cord injury field. Many of the most impressive things that we can do are not scalable.”
What’s Next?
Dr. Guest and colleagues will soon launch an investigator-initiated study using ARCEX stimulators. The researchers will look beyond the findings of the Nature Medicine study to investigate the therapy’s effects on spasticity and the optimal duration of the treatment.
“People were in the study for four months. They only received stimulation for two months and many people were still improving at the end,” Dr. Guest said. “We’re going to be studying a longer timeframe to try and figure out when people stop showing a recovery benefit.”
Tags: alumni, Dr. James Guest, Dr. Leslie Morse, neurological surgery, rehabilitation medicine, spinal cord injuries, The Miami Project to Cure Paralysis, transcutaneous neuromuscular electrical stimulation