In this SBIR Phase I proposal, Quantum NanoStim will develop a Closed Loop Omnidirectional Neuromodulation with Electromagnetic fields (CLONE) system to provide improved pain relief with greater specificity for those suffering from chronic neuropathic pain and opioid dependence. Chronic neck and low back pain accounts for the third highest amount of US health care spending (estimated $88 billion). Spinal cord stimulation (SCS) has provided pain relief for 60% of those with chronic pain and eliminated opioid use entirely in more than 50%. One of the leading barriers to the traditional SCS is encapsulation of the electrodes by glial cells, referred to as glial encapsulation or glial scar (gliosis). Several studies have shown advantages of magnetic-based neuromodulation relative to traditional electrical stimulation, including: (a) the magnetic field is not affected by glial encapsulation, (b) depolarization of the targeted neurons can occur from a greater distance more consistently, (c) magnetic stimulation affords high orientation specificity, and (d) increased battery life due to decreased implantable pulse generator (IPG) energy consumption. Magnetic stimulation can be used in combination with traditional SCS to form new hybrid waveforms. However, there are no current commercial devices that utilize this form of treatment. This modality is needed to advance the field of neuromodulation. The CLONE array will provide an ultra-thin and conformal blanket of stimulation contacts across the entire width of the dorsal spinal surface. A novel Active-Lead Controller Implantable Pulse Generator (AL-IPG) powers the chip safely, synchronizes with the active-lead electronics, configures the 10 programmable “therapy groups”, and ensures therapy pulses are delivered to the tissue. The CLONE system is a novel solution for the treatment of patients suffering from chronic pain and opioids. In this Phase I we will perform key development steps and demonstrate safety and feasibility, positioning us for completion of development and verification and validation during Phase II.

This phase 1 SBIR seeks to develop CLONE, a hybrid spinal cord stimulation (SCS) therapy for treating chronic neuropathic pain. The device development in Phase 1, will demonstrate safety and feasibility to inform final device design. The proposal will motivate further development and productization of an SCS therapy which can reduce pain and remove the dependence upon chronic opioids.