James D. Guest, MD, PhD, FAANS
Professor, Department of Neurological Surgery and The Miami Project to Cure Paralysis
Miller School of Medicine, Miami, FL
Abstract
Up-LIFT Pivotal Trial Read Out
The Up-LIFT study was a prospective, single-arm pivotal study designed to evaluate the safety and effectiveness of the ARC-EX System to treat upper extremity functional deficits in people with chronic tetraplegia. ARC-EX Therapy is external, programmed electrical stimulation that targets the spinal cord non-invasively and is designed to aid in functional recovery after SCI. The global study was conducted with 65 participants at 14 leading SCI centers in the United States, Europe, and Canada.
The study achieved all primary safety and effectiveness endpoints, and ARC-EX Therapy demonstrated significant improvements in upper limb strength, function, and sensation among people with chronic tetraplegia due to cervical SCI. At the end of the trial, 72% of trial participants were considered responders to non-invasive ARC-EX Therapy based on a conservative definition requiring responders to meet improvement criteria in both strength and functional domains vs. functional task practice rehabilitation alone. Notably, the number of responders increased to 90% when the definition included participants with improvements in at least one strength or functional outcome.
Study participants also reported reduced spasm frequency, improved sleep, and improved upper body sensation, including the sense of touch. 87% of participants reported that ARC-EX Therapy delivered improvements in overall quality of life. Self-care, a key component of independence after SCI, also improved significantly.
The results from our Up-LIFT pivotal study were published in Nature Medicine: Moritz, Chet, et al. “Non-invasive spinal cord stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.” Nature Medicine. 2024.
Bio
Dr. Guest is a neurosurgeon scientist with a multi-disciplinary interest in spinal cord medicine, especially spinal cord injury and myelopathy. Recovery-targeted therapeutics have tested repair, neuroprotection, and neuromodulation. Programs have been translated from in vitro and preclinical studies through Phase 1-3. Dr. Guest has been developing clinical trials with both academic and industry sponsors, writing applications for regulatory submission, patents, and providing guidance to several organizations.
In clinical practice, Dr. Guest has a strong interest in neurophysiology as a tool to assess spontaneous and therapeutics- promoted recovery. Dr. Guest enjoys serving as a member of the grants review panel for the California Institute for Regenerative Medicine because of the diversity of medical conditions and exciting evolution of stem cell, gene editing, and gene therapy applications that are reviewed.
