Project History and Clinical Research

One of the key early innovations for BrainGate came from Dr. Donald Humphrey of Emory University. In the late 1990s, Dr. Humphrey invented a method for brain-computer interfaces, later patented, that became the basis of this technology. Shortly thereafter, a Brown University affiliate called Cyberkinetics acquired the rights to the Emory intellectual property and launched a set of clinical trials for the first generation neural interface system at Brown. The result was the BrainGate Neural Interface System, a brain-implantable sensor on a bionic computer chip smaller than the size of a penny to monitor brain activity in patients and convert the intention of the user into commands.

In 2004, the US Food and Drug Administration granted Cyberkinetics 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 trial and four participants with tetraplegia (decreased ability to use the arms and legs) were enrolled in the study. The results were positive and the knowledge from the trials further helped in developing the BrainGate device.

In mid-2008, a new clinical trial was developed to continue this important research, currently being performed principally by Brown University and Massachusetts General Hospital under the guidance of Dr. Leigh Hochberg. In May 2009, the FDA provided a second Investigational Device Exemption for a clinical trial whose primary purpose is to investigate wireless control of thought. BrainGate, Inc. acquired the intellectual property for the BrainGate technology from Cyberkinetics.

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 University’s Department of Neuroscience, School of Engineering, and Carney Institute for Brain Science, and the VA RR&D Center for Neurorestoration and Neurotechnology of the U.S. Department of Veteran’s Affairs at the VA Providence Healthcare System. Additionally, Stanford University, Case Western Reserve University, Emory University and University of California, Davis joined the BrainGate consortium. 

The BrainGate Research Team -- comprised of neurologists, neuroscientists, engineers, computer scientists, neurosurgeons, mathematicians, and other researchers from the above named institutions -- focuses on developing brain-computer interface (BCI) technologies to restore the communication, mobility, and independence of people with neurologic disease, injury, or limb loss. Their research is focused not only on improving the ability to operate a computer, but also on providing people with ALS, spinal cord injury, and stroke with reliable, constant control over their environment.

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