Preparation for the Implantation of an Intracortical Visual Prosthesis in a Human

Abstract

Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing this collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Department of Defense, Washington Headquarters Services, Directorate for Information ABSTRACTThis project is to perform translational research tasks needed to prepare an intracortical visual prosthesis (ICVP) for testing in a human. No human trial testing 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.

Toward an Energy-Efficient High-Voltage Compliant Visual Intracortical Multichannel Stimulator

“…Table I summarizes the specifications and the performance of this system. A comparison between our design and other microstimulators, reported in [9], [13], [20], [21], and [46], is presented in Tables II and III. The specific reason of anom- developed microstimulator consumes 4.66-mW quiescent power, which is much lower compared with the system in [21].…”

“…The intracortical implant takes into account more diseases to treat, and a high resolution of visual function can be restored, as many microelectrodes can be implanted in the spacious primary visual cortex. Research teams have estimated that 625 [9]-1000 [10]- [13] phosphenes in the visual field are needed to create useful vision. For a wirelessly controlled microstimulator, data rate higher than most neuroprosthetic devices is required to stimulate such a large number of sites.…”