Title: Minimally Invasive Spinal Cord Stimulation for chronic pain
Funder: The Academy of Medical Sciences

Abstract: The primary aim of this research proposal is to design and manufacture a prototype of minimally invasive spinal cord stimulator. At the end of the project, the full MI-SCS system will be ready for first-in-human clinical trials. To achieve the primary aim, I will deliver the following objectives in an iterative manner: 1)Design and manufacture MI-SCS prototypes 2)Test and validate MI-SCS prototypes in human cadavers 3)Demonstrate long term stability (in vitro) Chronic pain represents the leading cause of disability worldwide. Existing treatments include pharmacological, non-pharmacological and surgical treatments. Many patients continue to experience pain despite a variety of treatments. Alternative treatment strategies are needed now because chronic pain is a wide-spread condition with suboptimal treatments. Spinal Cord stimulator (SCS) has potential as a treatment for chronic pain, but current technology has several limitations. Several studies have demonstrated superiority of the paddle over the cylindrical SCS. However, the standard paddle electrodes are associated with higher complication rates due to more invasive surgery. I have developed a prototype of minimally invasive SCS (MI-SCS) that replicates the efficacy of the paddle SCS, with the ease of use of the cylindrical version. MI-SCS is an ultra-thin and flexible electrode, thinner than human hair. It has an integrated set of channels, which can be filled with water or air, allowing a controllable change in the shape of the device (i.e., rolled to unrolled). MI-SCS is inserted via simple lumbar puncture technique and then expanded to cover a large area of spinal cord.

Lay abstract: Chronic pain affects more than one-third of the UK population and represents the leading cause of disability worldwide. We propose a solution to face this health crisis and unmet need in the form of a drug free device that can relieve chronic pain with minimal side effects. My invention is a new form of spinal cord stimulation that leverages recent advances in electrical technology to improve patient outcomes. Spinal Cord Stimulators (SCS) are implantable devices used to deliver electrical signals to alter nerve signals in the spinal cord. Existing SCS technology does not fulfil the unmet need, as it cannot offer the highly effective treatment without an unacceptably high rate of complications (5-10%), due to current designs (cylindrical and paddle). While cylindrical electrodes can be implanted percutaneously in day-surgery setting in a simple cost-effective procedure, they tend to be less effective and are often displaced requiring follow-up procedures to reposition them. The paddle is more effective and stable but requires an invasive surgical procedure with increased serious risks. We have developed a paddle-shaped SCS with the same electrode layout of clinically available paddle devices. It can be inserted percutaneously like cylindrical devices. This is made possible by using thin flexible biocompatible materials to create a device that can be rolled into a cylindrical-like structure for insertion and then actively unrolled to cover a larger area once inside the body. This project will focus on the critical steps to finalise our SCS prototype for pre-clinical and clinical trials.

Research activity codes: 5.3 MEDICAL DEVICES
Health categories: NEUROLOGICAL