Stanford University, California, researchers are enrolling participants in a study investigating the feasibility of people with paralysis using brain computer interface (BCI) technology that controls computer cursors, robotic arms, and other assistive devices.
Those who may be eligible to enroll in the trial include people with weakness of all four limbs resulting from cervical spinal cord injury (SCI), brainstem stroke, muscular dystrophy (MD), or motor neuron disease, such as amyotrophic lateral sclerosis. The study requires a 13-month commitment.
The pilot clinical trial, known as BrainGate2, is based on technology developed at Brown University (Brown), Providence, Rhode Island, and is led by researchers at Massachusetts General Hospital (MGH), Boston; Brown; and the Providence Veterans Affairs Medical Center (VAMC), Rhode Island. The researchers have now invited the Stanford team to establish the only trial site outside of New England.
Under development since 2002, BrainGate is a combination of hardware and software that directly senses electrical signals in the brain that control movement. The device-a 4x4mm silicon electrode array-is implanted in the cerebral cortex and records its signals; computer algorithms then translate the signals into digital instructions that may allow people with paralysis to control external devices.
“This technology is truly extraordinary, and I’m excited to begin testing it,” said Jaimie Henderson, MD, director of Stanford’s Stereotactic and Functional Neurosurgery program and lead investigator of the Stanford branch of the trial. “One of the biggest contributions that Stanford can offer is our expertise in algorithms to decode what the brain is doing and turn it into action.”
The trial as a whole is directed by Leigh Hochberg, MD, PhD, a critical care neurologist and neuro-engineer who is affiliated MGH, Brown, the Providence VAMC, and Harvard Medical School, Boston, Massachusetts.
Henderson, an associate professor of neurosurgery in Stanford’s School of Medicine, will be conducting the surgeries to implant the device and then evaluating its effects. He is working with Krishna Shenoy, PhD, associate professor in the Departments of Electrical Engineering, Bioengineering (affiliate), and Neurobiology (courtesy), Stanford, School of Engineering. Shenoy’s work focuses on understanding how the brain controls movement, and translating this knowledge to build high-performance neural prosthetic systems using sophisticated software. Henderson and Shenoy co-direct Stanford’s Neural Prosthetics Translational Laboratory. (Editor’s note: To read more about Shenoy’s work, go to www.oandp.com/articles/news_2011-08-22_01.asp )
“Drs. Henderson and Shenoy are leaders in the field of neural interfaces,” Hochberg said. “Our combined Brown-Harvard-MGH-Stanford-VA team of physicians, scientists, and engineers is well-suited not only to explore the possibilities and address the challenges of neural interface research, but simultaneously to make the fundamental discoveries that we hope will yield even greater advances in the development of restorative neurotechnologies for people with paralysis or limb loss.”
BrainGate is based on research and technology developed in the laboratory of John Donoghue, PhD, the Henry Merritt Wriston Professor of Neuroscience and Engineering at Brown, director of the Brown Institute for Brain Science and a senior research career scientist with the Providence VAMC. Donoghue co-directs the overall BrainGate research effort with Hochberg.
The BrainGate team is also engaged in research toward control of advanced prosthetic limbs and toward direct brain-based control of functional electrical stimulation (FES) devices for people with SCI, in collaboration with researchers at the Cleveland Functional Electrical Stimulation Center, Ohio.
Although the BrainGate researchers will record and report how well the technology operates, the primary purpose of this pilot study is to collect initial information about whether the device is safe to use in humans.
Editor’s note: This story has been adapted from materials provided by Stanford University.