The development of neural stimulators: A review of preclinical safety and efficacy studies

RK Shepherd; J Villalobos; O Burns; DAX Nayagam

Journal article

The development of neural stimulators: A review of preclinical safety and efficacy studies

RK Shepherd, J Villalobos, O Burns, DAX Nayagam

Journal of Neural Engineering | IOP PUBLISHING LTD | Published : 2018

DOI: 10.1088/1741-2552/aac43c

Abstract

Objective. Given the rapid expansion of the field of neural stimulation and the rigorous regulatory approval requirements required before these devices can be applied clinically, it is important that there is clarity around conducting preclinical safety and efficacy studies required for the development of this technology. Approach. The present review examines basic design principles associated with the development of a safe neural stimulator and describes the suite of preclinical safety studies that need to be considered when taking a device to clinical trial. Main results. Neural stimulators are active implantable devices that provide therapeutic intervention, sensory feedback or improved m..

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University of Melbourne Researchers

Robert Shepherd Author

Joel Villalobos Author

David Nayagam Author

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Grants

Awarded by National Institute on Deafness and Other Communication Disorders

Funding Acknowledgements

This work was supported by the following funding agencies for which we are most grateful: NIDCD (R01DC015031), NHMRC (APP1122055, APP1113680 and APP1120664), the Defense Advanced Research Projects Agency (DARPA) BTO under the auspices of Dr Doug Weber and Dr Eric Van Gieson through the Space and Naval Warfare Systems Center (N66001-15-2-4060), and the Garnett Passe and Rodney Williams Memorial Foundation. The Bionics Institute acknowledges the support of the Victorian Government through its Operational Infrastructure Support Program. We thank Jason Leavens, Dr Peter Seligman, Dr Tyler Best, Dr Stuart Cogan and Dr Kip Ludwig for helpful comments on an earlier draft, Mario Huynh and Ceara McGowan for research assistance and Dr Rylie Green, Dr Ulises Aregueta Robels and Dr Laura Poole-Warren for manufacturing the conductive hydrogel electrode used in figure 6.