Form factor determination for the Talon microIPG system to treat Chronic Migraine

Neogenesis Technologies, Llc, Moorpark CA

Investigators

Abstract

Project Summary Worldwide, tens of millions are afflicted with chronic migraine (CM), a highly debilitating neurological disorder. While abortive and preventative therapies exist, there are still nearly 4 million people (1M in the US alone) who do not respond adequately to these therapies and suffer from Intractable Chronic Migraine (ICM).17,18 Those patients are highly disabled by their disease and are faced with a significantly lowered productivity and quality of life with few options for relief. These patients who are unresponsive to most all preventive therapies including Botox and steroid injections typically progress to more invasive therapies such as occipital nerve stimulation (ONS). ONS has been used for two decades to treat a variety of headache disorders such as CM, Trigeminal Autonomic Cephalgias and cervicogenic headaches and is an effective treatment for reducing the number of headache days per month with superior efficacy to that of the ?gold standard? preventative treatments.1-15 Unfortunately, this method of ONS is also accompanied by an unacceptable level of device and procedure related adverse events because the therapy is delivered using off-label Spinal Cord Stimulation (SCS) systems. The SCS hardware has not been designed for ONS application and the device implant technique has not been standardized. The common adverse events seen when SCS hardware is used for ONS applications include lead migration, surgical discomfort, infection, skin erosion, lead breakage and disconnection.12 NeoGenesis proposes that the key to success for ONS therapy will be the development of a microIPG system designed for implantation in the back of the head, above the neck joint and closer to the target stimulation tissue. In this Phase 1 SBIR, we propose a research effort to define key design inputs, design the form factor of the microIPG system and develop repeatable and reproducible interventional techniques that will enable improved ONS stimulation reliability. Specific Aim 1 - Model the target anatomical areas for implantation and stimulation Specific Aim 2 ? Design microIPG and lead form factor concepts and fabricate prototypes Specific Aim 3 ? Evaluate and refine designs in simulated models and surgical environments Specific Aim 4 - Validate the final design in-vivo