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

Project Summary Worldwidetens of millions are afflicted with chronic migraineCMa highly debilitating neurological disorderWhile abortive and preventative therapies existthere are still nearlymillion peopleM in the US alonewho do not respond adequately to these therapies and suffer from Intractable Chronic MigraineICMThose patients are highly disabled by their disease and are faced with a significantly lowered productivity and quality of life with few options for reliefThese patients who are unresponsive to most all preventive therapies including Botox and steroid injections typically progress to more invasive therapies such as occipital nerve stimulationONSONS has been used for two decades to treat a variety of headache disorders such as CMTrigeminal 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 thegold standardpreventative treatmentsUnfortunatelythis 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 StimulationSCSsystemsThe SCS hardware has not been designed for ONS application and the device implant technique has not been standardizedThe common adverse events seen when SCS hardware is used for ONS applications include lead migrationsurgical discomfortinfectionskin erosionlead breakage and disconnectionNeoGenesis 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 headabove the neck joint and closer to the target stimulation tissueIn this PhaseSBIRwe propose a research effort to define key design inputsdesign the form factor of the microIPG system and develop repeatable and reproducible interventional techniques that will enable improved ONS stimulation reliabilitySpecific AimModel the target anatomical areas for implantation and stimulation Specific AimDesign microIPG and lead form factor concepts and fabricate prototypes Specific AimEvaluate and refine designs in simulated models and surgical environments Specific AimValidate the final design in vivoProject Narrative Chronic Migraine is a seriouspainful and debilitating neurological disorder afflicting millions of AmericansThis disease imparts a great cost to patients and their families by robbing them of their quality of lifethere is also a great cost to society due to their reduced productivityIn this Phase I SBIR NeoGenesis proposes the development of an innovative implantable microstimulator to treat patients with severe forms of Chronic Migraine and allowing them to have normal lives and returning to work