Clinical Trials

Clinical Trials 

The purpose 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 investigational BrainGate 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), VA Providence Healthcare System, Stanford University Medical Center, and Emory University School of Medicine. Clinical trial participants must live within a three-hour drive of Boston, MA, Providence, RI, Palo Alto, CA, Atlanta, GA, or Davis, CA. Clinical trial sites at other locations may be opened in the future. The study requires a commitment of 13 months.

BRAINGATE2 CLINICAL TRIAL SITES AND CLINICAL INVESTIGATORS

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

Leigh Hochberg, MD, PhD
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 MD and PhD 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, consults at the Spaulding Rehabilitation Center, and is a Senior Lecturer on Neurology at Harvard Medical School. He is also Professor of Engineering at Brown University, and Director of the Center for Neurorestoration and Neurotechnology, Rehabilitation Research and Development Service, Department of Veterans Affairs Medical Center, Providence, RI.

Sydney S. Cash, MD, PhD
Clinical Co-Investigator – MGH

Dr. Cash received his MD and PhD 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.

Ziv Williams, MD
Surgical Investigator – MGH

Dr. Williams is a neurosurgeon at Massachusetts General Hospital, Associate Professor of Neurosurgery at Harvard Medical School, Faculty at Harvard-MIT Health Sciences and Technology, and Faculty at Harvard Medical School Program in Neuroscience. He received his MD from Stanford University School of Medicine. His research laboratory is focused on investigating the neural computations that underlie complex sensory, motor, and cognitive behavior. His goal is to combine basic neurophysiology with clinical neurosurgery in order to develop novel approaches for treating patients with psycho-social, developmental, and traumatic neurological disorders.

Dan Rubin, MD, PhD
Clinical Co-Investigator – MGH

Dr. Rubin is a neurologist and researcher at Massachusetts General Hospital and an Instructor in Neurology at Harvard Medical School. Dr. Rubin joined the BrainGate team in 2019; his research interests are focused on understanding the dynamics of neural coding to develop electrophysiologic biomarkers and tools to facilitate recovery after acute and chronic neurologic injury. Dan received his MD and PhD in computational neuroscience from Columbia University studying circuit mechanisms of information processing in mammalian cortex and completed his neurology residency and neurocritical care fellowship at Massachusetts General Hospital and Brigham and Women’s Hospital in Boston, MA.

Stephen Mernoff, MD
Principal Investigator and Clinical Investigator – VA Providence Healthcare System

Dr. Mernoff is Chief of the VA Providence Healthcare System 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 MD 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.

Jaimie Henderson, MD
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 MD from Rush Medical College in Chicago, and completed his residency in Neurosurgery and fellowship training in Stereotactic and Functional Neurosurgery at Saint Louis University.

Nicholas Au Yong, MD, PhD
Principal Investigator and Surgical Investigator – Emory University School of Medicine

Dr. Au Yong is an assistant professor in the Department of Neurosurgery at Emory University School of Medicine and Coulter Department of Biomedical Engineering at Emory University and Georgia Tech. He received his MD and PhD degrees from Drexel University College of Medicine, and completed his residency in Neurosurgery at University of California, Los Angeles. Dr. Au Yong’s research program at Emory University is centered on the development of neuromodulation therapies for restoring motor control and homeostatic regulation through leveraging spinal and brain networks. His laboratory applies neuroengineering principles to characterize fundamental physiological mechanisms for neuromodulation applications.

David Brandman, MD, PhD
Principal Investigator and Surgical Investigator – University of California, Davis

Dr. David Brandman is an Assistant Professor of Neurological Surgery at UC Davis. He is a fellowship-trained neurosurgeon who specializes in helping patients with movement disorders, epilepsy, chronic pain, and spasticity. His clinical practice focuses on the use of neuromodulation and minimally invasive approaches that minimize side-effects without compromising effectiveness.
Dr. Brandman’s research focuses on developing restorative neuroprosthetics to help people living with chronic neurological diseases such as stroke, spinal cord injuries, and ALS. His primary focus is on developing brain computer interface technology: devices that record brain signals from people living with paralysis, and translate their brain signals into commands that can be used to control objects in their environment. He is the co-director of the UC Davis Neuroprosthetics Lab (https://neuroprosthetics.faculty.ucdavis.edu), and his research experience spans neurosurgery, computational neuroscience, and neural engineering.

CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.

Partner Institutions

Brown Emory University MGH Stanford School of Medicine University of California, Davis DVA