Over the past few years, there has been substantial scientific and medical progress toward designing powerful restorative neural interfaces for people with paralysis or limb loss. Much of this progress has resulted from decades of fundamental research, funded almost entirely by federal sources, including the National Institutes of Health, the Department of Veterans Affairs, and the Department of Defense, with critical help from philanthropic foundations.

In the late 1990s, the initial translation of fundamental neuroengineering research from bench to bedside that is, to pilot clinical testing would require a level of financial commitment ($10s of millions) available only from private sources. In 2002, a Brown University spin-off/startup medical device company, Cyberkinetics, Inc. (later, Cyberkinetics Neurotechnology Systems, Inc.) was formed to collect the regulatory permissions and financial resources required to launch pilot clinical trials of a first-generation neural interface system. The companys efforts and substantial initial capital investment led to the translation of the preclinical research at Brown University to an initial human device, the BrainGate Neural Interface System [Caution: Investigational Device. Limited by Federal Law to Investigational Use]. The BrainGate system uses a brain-implantable sensor to detect neural signals that are then decoded to provide control signals for assistive technologies. In 2004, Cyberkinetics received from the U.S. Food and Drug Administration (FDA) the first of two Investigational Device Exemptions (IDEs) to perform this research. Hospitals in Rhode Island, Massachusetts, and Illinois were established as clinical sites for the pilot clinical trial run by Cyberkinetics. Four trial participants with tetraplegia (decreased ability to use the arms and legs) were enrolled in the study and further helped to develop the BrainGate device. Initial results from these trials have been published or presented.

While scientific progress towards the creation of this promising technology wassteady and encouraging, Cyberkinetics financial sponsorship of the BrainGate research - without which the research could not have been started - began to wane. In 2007, in response to business pressures and changes in the capital markets, Cyberkinetics turned its focus to other medical devices. Although Cyberkinetics own funds became unavailable for BrainGate research, the research continued through grants and subcontracts from federal sources. By early 2008 it became clear that Cyberkinetics would eventually need to withdraw completely from directing the pilot clinical trials of the BrainGate device. Also in 2008, Cyberkinetics spun off its device manufacturing to new ownership, Blackrock Microsystems, Inc., which produces and is further developing research products as well as clinically-validated (510(k)-cleared) implantable neural recording devices.

Beginning in mid 2008, with the agreement of Cyberkinetics, a new, fully academically-based IDE application (for the BrainGate2 Neural Interface System) was developed to continue this important research. In May 2009, the FDA provided a new IDE for the BrainGate2 pilot clinical trial. The BrainGate2 pilot clinical trial is directed by faculty in the Department of Neurology at Massachusetts General Hospital, a teaching affiliate of Harvard Medical School; the research is performed in close scientific collaboration with Brown Universitys Department of Neuroscience, School of Engineering, and Brown Institute for Brain Sciences, and the VA RR&D Center for Neurorestoration and Neurotechnologyof the U.S. Department of Veterans Affairs at the Providence VA Medical Center. Additionally, in 2011 and 2013, Stanford University and Case Western Reserve University, respectively, joined the BrainGate Research Team as clinical sites and scientific sites. As was true of the decades of fundamental, preclinical research that provided the basis for the recent clinical studies, funding for BrainGate research is now entirely from federal and philanthropic sources.

The BrainGate Research Team at Brown University, Massachusetts General Hospital, Stanford University, Case Western Reserve University, and Providence VA Medical Center comprises clinicians, scientists, and engineers working together to advance understanding of human brain function and to develop neurotechnologies for people with neurologic disease, injury, or limb loss. We hope that these technologies will become a powerful means to restore communication, mobility, and independence to people with paralysis. The teams investigator-initiated research is focused on advancing the science and medicine of restorative neural interfaces.

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