Study Rationale: Over the past two decades, we have developed a therapy that restores walking after paralysis due to a spinal cord injury. This therapy uses an implanted neurostimulation prosthesis to modulate the activity of the neurons in the lumbar spinal cord that produce walking. The modulation is synchronized with the intention to execute movement that can be monitored using external sensors attached to the legs. We recently showed that this therapy also alleviates gait impairments and reduces the frequency of freezing of gait episodes in people with Parkinson’s disease (PD).
Hypothesis: Because gait deficits associated with PD and spinal cord injury are due to disruption of the neural signals traveling from the brain to the lumbar spinal cord, we hypothesize that a therapeutic strategy that targets the lumbar spinal cord to restore walking in people with paraplegia will restore gait in people with PD.
Study Design: We previously alleviated gait deficits in two individuals with PD using repurposed medical devices that were originally developed to treat pain. Scaling up this therapy requires medical devices specifically designed for alleviating gait deficits. For this purpose, the company ONWARD medical developed the first implantable platform for real-time control of spinal cord stimulation. Although this platform is optimized for people with spinal cord injury, the versatility of the design enables rapid adaptations of the hardware, firmware and software to meet the specific requirements of PD. Here, we will test this new platform in six people with PD.
Impact on Diagnosis/Treatment of Parkinson’s Disease: This project will validate a new technological solution to alleviate gait deficits and reduce the occurrence of freezing-of-gait in people with PD. This therapy acts synergistically with classically prescribed drugs and deep brain stimulation of the subthalamic nucleus.
Next Steps for Development: Completion of this project will provide a therapy tailored for people with PD and inform the design of a large-scale clinical trial to establish its safety and efficacy to alleviate gait deficits and reduce the occurrence of freezing-of-gait. The goal is to obtain a label from FDA and EU for this therapy within the next 5 years.
Trial Phase: Phase IIa