Illinois Institute of Technology Chicago United States
This project is to perform translational research tasks needed to prepare an intracortical visual prosthesis ICVP for testing in a human. No human trialtesting of the prosthesis will occur under the funded work. Preparatory tasks include final maturation of the implantable hardware, pre FDA IDE testing of the ICVP in non-human primates, reliability and biocompatibility testing, development of a human testing protocol, development of a human volunteer selection and assessment protocol, preparation of an investigation device exemption application IDE to the FDA. Progress to-date has been somewhat hampered by delayed approval of the psychology testing protocols human subjects, and the animal testing protocols non-human primates, by the USARMYMC. However, all protocol approvals have now been obtained. This delay has also slowed the spending of funds for these areas within the first year. The work focused on technology maturation has been highly productive. Sample stimulator units have been subjected to brutal environmental testing with 100 survival. Larger numbers of stimulator units are in the process of being constructed to provide statistical power for the environmental testing. Following the human protocol acceptances, work has commenced at both IIT and Johns Hopkins for the development of the testing and assessment protocols. A graduate student from IIT has initiated work within the laboratory of Dr. Dagnelie at JHU. Analysis of interview data from the earlier Dobelle visual prosthesis recipients has already yielded valuable insight about the volunteer recruitment and participation process. Sixteen publications and presentations have resulted from the funded work, and several publications are in preparation. While the project is projected for a 1-year no-cost extension request, due to the slow start-up, it is anticipated that by the end of the project all parts of the SOW will be complete, with the ICVP ready for clinical testing in a human trial.