Public Release:  Case Western Reserve University joins BrainGate clinical trial

Experts in muscle stimulation technology and brain-computer interfaces working to restore movement for people with paralysis

Case Western Reserve University

CLEVELAND -- Researchers at Case Western Reserve University and its primary affiliate University Hospitals (UH) Case Medical Center will begin testing the first of two technologies they plan to combine in a new effort to enable people with paralysis to regain some control of their arms and hands.

The physicians and scientists are now enrolling participants in the first part of this effort, a pilot clinical trial to assess the safety and feasibility of recording brain activity for control of assistive devices. The brain activity is recorded as the participants imagine using their arms and hands.

Long-term, the goal is to bypass severed connections between the brain and the paralyzed muscles by using the participants' own brain signals as commands directing electrical impulses to their muscles and generating movement. To do this, the investigational brain recording technology studied in this trial will be combined with CWRU's long-standing expertise in restoring movement to paralyzed individuals using electrical stimulation.

Robert Kirsch, chair of the Case Western Reserve University biomedical engineering department and executive director of the Functional Electrical Stimulation Center of Excellence at the Louis Stokes Cleveland VA Medical Center, has been working with researchers at Brown University and Massachusetts General Hospital for nearly seven years, laying the groundwork for launching the study site in Cleveland.

"When we ask patients with tetraplegia their number one priority, they tell us they want to rub their nose and eyes," Kirsch said. "It's the simple things they can't do. They rely on caregivers for everything, and these technologies could restore some independence."

Kirsch will lead the team in Cleveland with Benjamin Walter, MD, and Jonathan Miller, MD, who are assistant professors at Case Western Reserve Medical School and on staff at UH Case Medical Center. Dr. Walter, principal investigator for the clinical trial in Cleveland, is the medical director of the Deep Brain Stimulation Program and Dr. Miller is the director of Functional and Restorative Neurosurgery at UH Case Medical Center.

To begin this study, called the BrainGate2 pilot clinical trial, Dr. Miller will implant a tiny sensor (about the size of a baby aspirin) containing 96 electrodes to record the activity of neurons in the surface layers of the brain. In people with paralysis, the BrainGate2 study has previously shown that the brain can continue to generate patterns of activity when a person attempts or imagines movement. The system used to record and translate these patterns is called a brain-computer interface.

The Case Western Reserve BrainGate2 site is part of a larger clinical trial assessing the safety and feasibility of the brain-computer interface system in people with paralysis. BrainGate technology was developed in the laboratory of John Donoghue, Ph.D. at Brown University, and the overall trial is directed by Leigh R. Hochberg, MD, Ph.D., of the Massachusetts General Hospital, Brown University, the Center for Neurorestoration and Neurotechnology at Providence VA Medical Center, and Harvard Medical School.

The BrainGate collaboration, recently joined by Stanford University, has used the investigational BrainGate technology to record the patterns of brain activity in people with paralysis. As reported in journals such as Nature and the Journal of Neural Engineering, participants have been able to use the BrainGate system to move a computer cursor or operate an advanced prosthetic arm just by thinking about it.

"By launching a BrainGate trial site with our long-time colleagues at Case Western, we have the opportunity to work toward the long-term dream for this research - to reconnect a disconnected nervous system, and to one day allow someone with cervical spinal cord injury to regain intuitive control over her limb," said Dr. Hochberg. "I'm thrilled that we have the opportunity to bring together such extraordinary researchers, all focused on restoring mobility, communication, and independence for people with paralysis."

"The ultimate goal here in Cleveland is to enable a paralyzed individual to control their own limb," said Dr. Walter. "We have the experience to put the two systems together."

"Being able to map brain activity, at the level of even a few dozen individual neurons, is fundamental to understanding how the brain works," said Donoghue, Director of the Institute for Brain Science at Brown University and the VA Center for Neurorestoration and Neurotechnology. "Even more importantly, our emerging ability to 'decode' this brain activity in real time could eventually restore neurologic functions lost as a result of disease or injury."

Kirsch is among the experts in Cleveland who use functional electrical stimulation (FES) to enable paralyzed individuals to regain some control over their arms and hands. His research group studies how the nervous system normally controls movement and patterns of muscle activation. From that, they have developed computer software and hardware that sends electrical impulses to electrodes implanted in the arm of a patient, stimulating muscles to lift the arm and reach or grasp a cup. FES technology was pioneered in Cleveland over 20 years ago by Hunter Peckham, Distinguished University Professor and Donnell Institute Professor of biomedical engineering at CWRU.

But, in the severest cases, the treatment has yet to restore the function these scientists think is possible. Individuals with profound paralysis have difficulty giving their FES systems commands, which is why the brain recording technology is so enticing to the research team.

To better understand the relationship between brain activity and movement, BrainGate2 users will be asked to learn to control a "virtual arm" by thought. In the planned research, they will attempt to control the virtual arm, developed by Kirsch's research team, to perform simple reaching tasks, or complex activities, such as drinking from a mug or brushing teeth, all within the virtual-reality world displayed on a computer screen.

The researchers will explore how to decode participants' intent from their brain recordings and how to translate these intentions into stimulation commands for the FES system. The goal is to allow participants to use their arms and hands for simple tasks, just by thinking about them.

In addition to Kirsch, Dr. Walter, and Dr. Miller, the Cleveland BrainGate2 team includes co-investigator Bolu Ajiboye, Ph.D., an assistant professor of biomedical engineering at CWRU and FES Center investigator at the Cleveland VA.

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Individuals interested in becoming involved in the Cleveland trial, please call Dr. Walter's office: 216-844-8285 or by emailing braingate2@case.edu. Information about the trial site in Cleveland can be found at braingate2.case.edu .

Information about the research and pilot clinical trial sites in New England and Palo Alto can also be found at www.braingate2.org.

Primary funding for the Cleveland BrainGate2 site is from the National Institutes of Health (the Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Center for Medical Rehabilitation Research), and from the Department of Veterans Affairs Rehabilitation Research and Development Service. In addition to the above, the BrainGate research is also supported in part by the National Institute on Deafness and Other Communication Disorders, the National Institute of Neurological Diseases and Stroke, and the National Institute of Biomedical Imaging and Bioengineering; an interagency agreement between the Defense Advanced Research Projects Agency and the Department of Veterans Affairs; the MGH Deane Institute, the Katie Sampson Foundation, and the Craig H. Neilsen Foundation.

Case Western Reserve University is one of the country's leading private research institutions. Located in Cleveland, we offer a unique combination of forward-thinking educational opportunities in an inspiring cultural setting. Our leading-edge faculty engage in teaching and research in a collaborative, hands-on environment. Our nationally recognized programs include arts and sciences, dental medicine, engineering, law, management, medicine, nursing and social work. About 4,200 undergraduate and 5,600 graduate students comprise our student body. Visit case.edu to see how Case Western Reserve thinks beyond the possible.

About University Hospitals

University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our health system is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University. University Hospitals Case Medical Center is the 2012 recipient of the American Hospital Association - McKesson Quest for Quality Prize for its leadership and innovation in quality improvement and safety.

For more information, go to www.uhhospitals.org

Additional information about BrainGate2 can be accessed at www.braingate2.org. Inquires related to the research can be directed to clinicaltrials@braingate2.org. The BrainGate pilot clinical trial is performed under an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA), and is registered with the National Clinical Trials registry at: http://www.clinicaltrials.gov/ct2/show/NCT00912041

CAUTION: Investigational Device. Limited by Federal Law to Investigational Use.

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $750 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine. In July 2012, MGH moved into the number one spot on the 2012-13 U.S. News & World Report list of "America's Best Hospitals.".

Founded in 1764 and a member of the Ivy League, Brown University is globally acclaimed for its culture of independent thinking and academic excellence. For decades, Brown faculty and students have pursued multidisciplinary research in areas such as brain science, digital humanities, nanoscience, and population studies. Since 2002, under a strategic plan, Brown has invested significantly in research, resulting in a 65 percent gain in external research awards, a 33 percent increase in graduate enrollment and a rise in total faculty of 16 percent.

For more than 85 years, the Veterans Affairs (VA) Research and Development program has been improving the lives of Veterans and all Americans through health care discovery and innovation. The VA Research program is unique because of its focus on health issues that affect Veterans. It is part of an integrated health care system with a state-of-the-art electronic health record and has come to be viewed as a model for superior bench-to-bedside research. To learn more about VA Research, visit www.research.va.gov.

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