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Clinical Trials - Now Recruiting

The purpose of the first phase of the pilot clinical study of the BrainGate2 Neural Interface System is to obtain preliminary device safety information and to demonstrate the feasibility of people with tetraplegia using the System to control a computer cursor and other assistive devices with their thoughts. Another goal of the study is to determine the participants’ ability to operate communication software, such as e-mail, simply by imagining the movement of their own hand. The study is invasive and requires surgery.

Individuals with limited or no ability to use both hands due to cervical spinal cord injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis (ALS) or other motor neuron diseases are being recruited into a clinical study at Massachusetts General Hospital (MGH) and Stanford University Medical Center. Clinical trial participants must live within a three-hour drive of Boston, MA or Palo Alto, CA. Clinical trial sites at other locations may be opened in the future. The study requires a commitment of 13 months.

For more information about the study, please contact us at:
clinicaltrials@braingate2.org
Telephone: 617-726-4218 (Dr. Hochberg)
View a BrainGate System educational animation by clicking here.

Clinical Investigators in the trial are:

Leigh Hochberg, M.D., Ph.D. (Sponsor-Investigator and Principal Investigator – MGH) -- Dr. Hochberg is the lead clinical investigator for the Feasibility Study of the BrainGate2 Neural Interface System for Persons with Tetraplegia. Dr. Hochberg was a key contributor to the original BrainGate trials, and is a neuroscientist with expertise in motor cortical neurophysiology. He received his M.D. and Ph.D. degrees from Emory University, completed his Neurology residency and was a Chief Resident at Massachusetts General Hospital (MGH) and Brigham & Women’s Hospitals (BWH). Dr. Hochberg is a specialist in stroke/neurocritical care, is on the Neurology staff at MGH and BWH, consults at the Spaulding Rehabilitation Center, and is a Visiting Associate Professor of Neurology at Harvard Medical School. He is also Associate Professor of Engineering at Brown University, and an Investigator in the Center for Restorative and Regenerative Medicine, Rehabilitation Research and Development Service, Department of Veterans Affairs Medical Center, Providence, RI.

Jaimie Henderson, M.D. (Principal Investigator and Surgical Investigator – Stanford University) –- Dr. Henderson is Professor of Neurosurgery, Director of the Stanford program in Stereotactic and Functional Neurosurgery, and Co-Director of the Stanford Neural Prosthetics Translational Laboratory (NPTL). He received his M.D. from Rush Medical College in Chicago, and completed his residency in Neurosurgery and fellowship training in Stereotactic and Functional Neurosurgery at Saint Louis University.

Stephen Mernoff, M.D. (Principal Investigator and Clinical Investigator – Providence VA Medical Center) –- Dr. Mernoff is Chief of the Providence VA Medical Center Neurology Section, Associate Professor of Neurology at The Warren Alpert Medical School of Brown University, and Medical Director of the Neurorehabilitation Program at the Rehabilitation Hospital of Rhode Island. He received his M.D. from the New York University School of Medicine, and completed his residency in Neurology and fellowship training in Memory Disorders at Boston University Medical Center, and additional fellowship training in Neurorehabilitation at Braintree Hospital.

Sydney S. Cash, M.D., Ph.D. (Clinical Co-Investigator – MGH) – Dr. Cash received his M.D. and Ph.D. degrees from Columbia College of Physicians and Surgeons, completed his Neurology residency and was a Chief Resident at MGH and BWH. Dr. Cash is a specialist in epilepsy with research expertise in cortical microphysiology, including research with the NeuroPort/BrainGate array, conducted with Dr. Eskandar. Dr. Cash is on the Neurology staff at MGH, and is an Instructor in Neurology at Harvard Medical School.

Merit E. Cudkowicz, M.D., M.Sc. (Clinical Co-Investigator – MGH) –- Dr. Cudkowicz is an Associate Professor of Neurology at Harvard Medical School. She is trained in Neurology and Experimental Therapeutics with a focus in neurodegenerative disorders, and was a co-investigator for the original BrainGate pilot trials for people with ALS. Dr. Cudkowicz directs the MGH ALS clinic and the Neurology Clinical Trials Unit at MGH. She is co-chair of the Northeast ALS consortium and is leading several multi-center clinical trials in ALS.

Emad N. Eskandar, M.D. (Surgical Investigator – MGH) –- Dr. Eskandar is Associate Professor of Neurosurgery at Harvard Medical School, and the Director of Stereotactic and Functional Neurosurgery at MGH. His research laboratory is focused on brain recording and stimulation to understand the role of the anterior striatum in learning, and the role of subthalamic nucleus and the globus pallidus interna in movement control in Parkinsonian patients undergoing surgery for deep brain stimulation. He has also placed the NeuroPort/BrainGate array in patients with epilepsy in collaborative research with Dr. Cash.

The pilot clinical trial of the BrainGate2 Neural Interface System is registered here at ClinicalTrials.gov.

Last Updated: 3/5/2014



Research supported by:

Rehabilitation R&D Service, Department of Veterans Affairs logo National Institutes of Health logo National Institute for Biomedical Imaging and Bioengineering logo The Eunice Kennedy Shriver National Institute of Child Health and Human Development logo National Institute on Deafness and Other Communication Disorders logo National Institute for Neurological Disorders and Stroke logo National Science Foundation logo Defense Advanced Research Projects Agency logo
Katie Samson Foundation logo Doris Duke Charitable Foundation logo MGH-Deane Institute for Integrated Research on Atrial Fibrillation and Stroke logo
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