The broader impact and commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to treat chronic back and lower limb pain more effectively using a novel stimulation active paddle electrode technology. Lower back pain affects more than 100M Americans. While spinal cord neuromodulation is successful for about 60% of patients, many people remain untreated and suffer from chronic pain. Low-back pain is the most difficult to treat due as conventional electrode technology cannot selectively deliver energy to these fibers due to the bulky paddle electrode volume associated with the legacy manufacturing processes. Furthermore, to achieve maximal pain relief, neurosurgeons must wake the subjects during an operation to verify if the patient senses pain relief as the electrode is positioned. Many subjects undergo multiple operations due to inaccurate electrode alignment or movement of the electrode over time due to physical activity. The proposed active grid electrode technology will double the therapeutic surface area, including providing therapy to low-back fibers which are not accessible by conventional electrodes. The technology will improve low-back pain relief, as well as use wireless programming to alter the therapy in the event of electrode movement, avoiding the need for re-operation.
The proposed project seeks to double the area of the spinal cord which can receive therapeutic benefit, by developing an active stimulation-grid electrode technology. By positioning a tiny electronic circuit within the paddle electrode, we can create a 48 or 96 channel stimulation grid which can be programmed to deliver precision therapy. To accomplish these goals, we will perform three critical tasks including: (1) design of the paddle electrode using electric field simulations to current-steer therapy to low-back pain fibers, (2) develop a prototype of the active stimulation grid lead using a tiny ceramic hermetic package and micro-circuit, and (3) validation of the recruitment of low-back pain fibers in the spinal cord. The goal of the project is to develop proof-of-concept data to show that active-lead technology can improve delivery of therapy to low-back pain fibers. Validation will be performed by recording the evoked potentials across the surface of all dorsal columns while stimulation is selectively applied to lateral electrodes caudal to the recording electrodes. Electromyography control electrodes will be positioned within adjacent muscles to verify that dorsal roots are not activated.
