Research Project
8057777
DESCRIPTION (provided by applicant): Deep Brain Stimulation (DBS) devices - 'brain pacemakers'- have emerged as a revolutionary new approach to the treatment of neurological disorders. DBS therapy uses controllable electrical stimulation delivered to specific deep brain structures through an implantable lead having multiple electrode contacts. DBS is currently the treatment of choice for late-stage Parkinson's Disease and is approved for essential tremor, dystonia, and obsessive-compulsive disorder. It is under investigation for depression, chronic vegetative state, obesity, and dementia. There is a clinical need-and significant commercial opportunity-for innovative DBS leads and next-generation DBS systems that provide enhanced targeting, stimulation selectivity and tuning, and MR- safety. NeuroNexus has previously developed and demonstrated feasibility of an innovative MR-safe DBS lead (the Deep Brain Stimulation Array, or DBSA) for precise, selective, and tunable therapeutic electrical stimulation of deep brain targets. The proposed Phase II SBIR project is directed at further development of the DBSA to a fully validated, clinical-grade DBS lead that, at the end of this project, will be positioned for clinical evaluation and then commercialization. This project will be directed by NeuroNexus with pre-clinical testing conducted at MPI Research, Inc. and the University of Michigan. The project structure follows a standard product development process for clinical products to comply with regulatory requirements for design controls and testing. The explicit goal of this project is to complete all development, verification, and validation stages that are required to prepare an IDE submission to gain FDA permission to commence the initial clinical trial for the DBSA. The technical innovation of the project centers on the use of advanced microfabricated electrode technology to create an advanced clinical DBS lead that has increased capabilities for delivering therapeutic stimulation patterns to deep brain targets in a safe and efficacious manner. This project will result in an innovative, clinical-grade DBS lead that will be positioned for commercialization as part of a next-generation DBS system, as well as an innovative research product for neuroscience research. In so doing, this project will increase the impact of leading-edge neurotechnology on improving and advancing treatments of significant neurological disorders in the US and global markets. PUBLIC HEALTH RELEVANCE: Deep brain stimulation (DBS) devices - 'brain pacemakers'- have recently emerged as an exciting novel neurotechnology for treating severe movement disorders, such as Parkinson's disease and Essential Tremor. This project will develop a 2nd-generation DBS electrode system that will provide significant performance improvements over the current clinically approved DBS electrode system. There is expected to be a significant societal benefit of this project through improved care and quality of life for patients receiving DBS therapies.
