| Literature DB >> 24528900 |
Jennifer L Collinger1, Michael A Kryger, Richard Barbara, Timothy Betler, Kristen Bowsher, Elke H P Brown, Samuel T Clanton, Alan D Degenhart, Stephen T Foldes, Robert A Gaunt, Ferenc E Gyulai, Elizabeth A Harchick, Deborah Harrington, John B Helder, Timothy Hemmes, Matthew S Johannes, Kapil D Katyal, Geoffrey S F Ling, Angus J C McMorland, Karina Palko, Matthew P Para, Janet Scheuermann, Andrew B Schwartz, Elizabeth R Skidmore, Florian Solzbacher, Anita V Srikameswaran, Dennis P Swanson, Scott Swetz, Elizabeth C Tyler-Kabara, Meel Velliste, Wei Wang, Douglas J Weber, Brian Wodlinger, Michael L Boninger.
Abstract
Our research group recently demonstrated that a person with tetraplegia could use a brain-computer interface (BCI) to control a sophisticated anthropomorphic robotic arm with skill and speed approaching that of an able-bodied person. This multiyear study exemplifies important principles in translating research from foundational theory and animal experiments into a clinical study. We present a roadmap that may serve as an example for other areas of clinical device research as well as an update on study results. Prior to conducting a multiyear clinical trial, years of animal research preceded BCI testing in an epilepsy monitoring unit, and then in a short-term (28 days) clinical investigation. Scientists and engineers developed the necessary robotic and surgical hardware, software environment, data analysis techniques, and training paradigms. Coordination among researchers, funding institutes, and regulatory bodies ensured that the study would provide valuable scientific information in a safe environment for the study participant. Finally, clinicians from neurosurgery, anesthesiology, physiatry, psychology, and occupational therapy all worked in a multidisciplinary team along with the other researchers to conduct a multiyear BCI clinical study. This teamwork and coordination can be used as a model for others attempting to translate basic science into real-world clinical situations. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.Entities:
Keywords: brain; clinical trials; methodology; translational research
Mesh:
Year: 2013 PMID: 24528900 PMCID: PMC3929226 DOI: 10.1111/cts.12086
Source DB: PubMed Journal: Clin Transl Sci ISSN: 1752-8054 Impact factor: 4.689