NICOP - Preclinical Validation of First-in-Man Endovascular Brain Machine Interface Device: Stentrode
Abstract
This proposal is submitted in response to Broad Agency Announcement N00014-17-S-B001oflong-range Office of Naval Research scientific projects that was published on Amended on21November 2016.Technical Description: Paralysis afflicts millions of people world-wide" including veterans.There is no cure. Attempts to restore lost motor function through direct, brain machine interfacecontrol of ro""botic prostheses have shown promise, however, risky surgical procedures andelectrode failure are preventing clinical translation ef""forts. To address this unmet need, we havedeveloped a novel brain machine interface technology that overcomes the current hurdles w"iththe use of minimally invasive surgery. Preliminary proof-of-concept trials using our deviceimplanted via a blood vessel have de"monstrated the capacity of our technology to record highfidelity, movement- related neural information in awake and freely moving a""nimals for durationslonger than six months (Oxley 2016). Further, we have demonstrated that these recordings canbe achieved withou"t electrode degradation (Opie 2016a) or vascular occlusion (Opie 2016b)and have developed signal processing algorithms that can translate the acquired neuralinformation into useful computer commands.Relevance: This technology is relevant to ONR Global and DARPA", in that it seeks to solve aproblem that DoD has been investigating for many years. The problem, is with achieving reliablecontro"l of Brain Machine Interfaces (BMIs) to drive dexterous neural prosthetic actuators.Soldiers returning from the field with loss of limb and other neurological injuries have minimalmeans of neurological recovery. The field of BMI technology represents a convergence ofmedicine and engineering and seeks to solve this problem. Our technology is emerging as apromising solution that avoids craniotomy and still achieves high fidelity recordings.US collaborators: We have a relationship with ONR Global via Associate Director" Wu, Pae(ONR Global Office Program Code 600) who has been collaborating with us on a futuredirection and relationship with ONR Glo"bal. We have also have support from DARPA programmanager Doug Weber on this effort.Desired Outcomes: Our multidisciplinary team is now poised to translate our paradigm-shiftingresearch into clinical application. For approval to conduct our first-in-human trial" at the RoyalMelbourne Hospital, Australia, this project aims to complete the preclinical safety testing of ouroptimised, minimall"y invasive neural interface. We will complete the initial safety and efficacytrials required by the FDA to gain early feasibility study (EFS) investigational device exemption(IDE) approval for the conduction of a pivotal clinical trial in the USA. We anticipate severalscientific publications that provide novel knowledge contribution toward the biologicalmechanism of tissue incorporation o"f our highly novel interface, the changes in impedance andthe histopathological response to the device. We have a strong track reco""rd, having alreadypublished in Nature Biotechnology. We anticipate further high-impact publications.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 23, 2018
- Source ID
- N629091812039
Entities
People
- Tom Oxley
Organizations
- Office of Naval Research
- United States Navy
- University of Melbourne