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

Journal of Neural Engineering
Robert K ShepherdDavid A X Nayagam

Abstract

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. 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. Neural stimulators are active implantable devices that provide therapeutic intervention, sensory feedback or improved motor control via electrical stimulation of neural or neuro-muscular tissue in response to trauma or disease. Because of their complexity, regulatory bodies classify these devices in the highest risk category (Class III), and they are therefore required to go through a rigorous regulatory approval process before progressing to market. The successful development of these devices is achieved through close collaboration across disciplines including engineers, scientists and a surgical/clinical team, and the adherence to clear design principles. Preclinical studies form one of sev...Continue Reading

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Citations

Nov 6, 2018·Nature Reviews. Gastroenterology & Hepatology·Sophie C PayneMartin J Stebbing
Oct 15, 2019·Advanced Materials·Florian FalleggerStéphanie P Lacour
Mar 17, 2020·Advanced Materials·Giuseppe SchiavoneStéphanie P Lacour
Mar 7, 2020·Journal of Neural Engineering·Ashley N DalrympleRobert K Shepherd
Mar 20, 2019·The Analyst·Alexander R HarrisAntonio G Paolini
Sep 12, 2020·Journal of Neural Engineering·Robert K ShepherdJames B Fallon
Feb 6, 2021·Journal of the Mechanical Behavior of Biomedical Materials·Linze LiLuming Li
Feb 16, 2021·Frontiers in Bioengineering and Biotechnology·Weiyang YangWen Li
Feb 13, 2021·Journal of Neural Engineering·Robert K ShepherdJames B Fallon
Oct 30, 2020·Neuron·Giuseppe SchiavoneStéphanie P Lacour
Apr 27, 2021·Advanced Science·Estelle A CuttazRylie A Green
Apr 30, 2021·Frontiers in Neuroscience·Maryam HejaziDavid J Garrett
May 22, 2021·Acta Biomaterialia·Poppy Oldroyd, George Malliaras
Apr 9, 2021·Journal of Neural Engineering·Giuseppe SchiavoneStéphanie P Lacour

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