Neural stimulation techniques, generally known as “neuromodulation,” have revealed untapped recovery potential after spinal cord injury (SCI). The Miami Project has been selected, and is currently seeking research participants, as a participating site in the ongoing Up-LIFT ARC Therapy Multi-Center Clinical Study. The non-invasive spinal cord stimulation study has a primary goal of reporting safety of the stimulation device, as well as any changes in upper extremity motor function and performance after completing training with the assistance of the device. The study will include people living with C2-C8 incomplete cervical spinal cord injury.
“We are happy to be one of the sites studying this device. The study will help us answer some important questions, specifically if the device is safe and does it provide benefit to those with chronic cervical SCI. If successful, the device could enter use in post-SCI rehabilitation and inform potentially more effective experimental approaches in combination with other treatments such as neuromodulating drugs,” said Dr. James Guest.
In order for the researchers to ensure that benefits can be directly attributed to the stimulation device, all enrolled participants will first undergo a guided, in-clinic functional task practice program—similar to rehabilitation—lasting approximately two months to help optimize their upper extremity function without applied stimulation. This is a method to provide a subject specific control. After this initial training period, all participants will then commence combined task practice and ARC Therapy stimulation over another period of 2 months.
The ARCex (“ex” for “external”) device will be used to deliver transcutaneous electrical stimulation through electrodes placed on the skin above the spine around the participant’s level of injury. The stimulation is designed to enhance, not replace, the functional task practice will follow established rehabilitation protocols that are specific to the individual subject’s specific needs and capabilities. All training by the individuals will be graded to accommodate any performance improvement over time, thus maximizing any potential benefit to each of the research participants. Each enrolled person will participate in up to twenty in-clinic training sessions per month. At the end of training period, the improvement in upper extremity function will be measured and used to assess the progress.
The primary outcome measures for this important study will include the safety of the device, improvement in upper extremity function, advances in performance, and finally the magnitude of changes that are clinically meaningful.
All performance metrics will be assessed at enrollment, at the completion of the initial training period, and at the end of the ARC Therapy assessment period. All research participants with clinically meaningful gains in multiple performance areas resulting from the stimulation and rehabilitation with Up-LIFT’s ARCex device will be considered positive responders to the study.
The study is sponsored by ONWARD Medical, Inc. The company’s neuromodulation products include the ARCex transcutaneous stimulator and forthcoming ARCim (“im” for “implantable”) epidural stimulator, both intended to improve motor function in individuals with spinal cord injury. James D. Guest, M.D., Ph.D., Clinical Professor, Department of Neurological Surgery and The Miami Project to Cure Paralysis will be the Principal Investigator at the Miller School site. Former Miami Project scientist Edelle Field-Fote, PT, Ph.D., now of the Shepherd Center – Crawford Research Institute, and Chet Moritz, Ph.D. from the University of Washington are leading the overall study. People who meet the criteria and who are Interested in participating with The Miami Project should call 305-243-7108 or email email@example.com.