February 23, 2023

Personalized Epidural Electrical Stimulation of the Lumbar Spinal Cord for Clinically Applicable Therapy to Restore Mobility After Paralyzing Spinal Cord Injury

7th Call, PM / PH Research

Short Summary

A prototype of our “STIMO” therapy, based on the stimulation of the lumbar spinal cord, restored walking to nine people that were wheelchair bound for years due to spinal cord injury. While these breakthroughs brought hope to people paralyzed by spinal cord injury, this prototype relies on unfit-for-purpose medical devices and experts that tune the therapy for weeks to make it effective. We recently developed “ARCIM” devices designed specifically for spinal stimulation that offer a wide range of personalization options. In addition, artificial intelligence techniques have the potential to substantially increase the effectiveness of our STIMO therapy. In this project, we will develop procedures that use artificial intelligence techniques to personalize and automatize STIMO therapy based on ARCIM devices. These procedures will remove the main obstacle towards widespread use of the STIMO therapy, which has the potential to drastically improve the lives of people paralyzed by spinal cord injury.

Goals

We will develop and clinically validate procedures to achieve the most effective and clinically applicable STIMO therapy. These procedures will allow: 1. Selection of the lead out of several available that is most suited to the anatomy of each user. 2. Ensuring the placement of the lead in the most effective location for each user. 3. Designing the stimulation protocols that enable the most effective leg movements for each user individually. We will design these procedures to be used by treating physicians though a web-based portal with little or no expert supervision. The high level of usability and automation will enable widespread use of the STIMO therapy.

Significance

About 2.5 million people cannot walk due to paralyzing spinal cord injury. This condition has no cure and results in permanently reduced quality of life, high emotional burden and life-long social and financial costs. Lifetime direct costs of this condition for each affected person are estimated to $2.3 million with indirect costs up to six times higher. Our revolutionary STIMO therapy is capable of restoring mobility to people with spinal cord injury. In this project, we will develop tools that exploit the personalization opportunities of the new ARCIM STIMO devices to both considerably advance the effectiveness of the therapy and remove or completely abolish its reliance on experts. Success of this project will open a clear path towards its widespread use in clinical practice. As a commercial partner in the consortium, ONWARD Medical will directly pursue the next steps towards regulatory approval and worldwide distribution of the personalized STIMO therapy, thereby ensuring that our work transforms the lives of many people paralyzed by spinal cord injury and decrease the overwhelming societal and economic burden of this condition.

Background

Our STIMO therapy uses an implanted stimulator connected to a 16-electrode paddle lead that is surgically inserted within the spinal column that protects the spinal cord. A control computer sends wireless commands to the implanted stimulator to deliver small electrical stimulation pulses that restore the ability of the spinal cord to move the leg muscles. By controlling the location and time of the stimulation, the computer synchronizes the evoked movement with the movement intentions of the user. New ARCIM stimulator and paddle leads are specifically designed to stimulate the spinal cord to restore walking and allow high level of personalization.

Publications

Lorach, H., Galvez, A., Spagnolo, V. et al. Walking naturally after spinal cord injury using a brain–spine interface. Nature 618, 126–133 (2023). https://doi.org/10.1038/s41586-023-06094-5