Clinical Trials

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) Case Western Reserve University, Providence VA Medical Center, and Stanford University Medical Center. Clinical trial participants must live within a three-hour drive of Boston, MA, Cleveland, OH, Palo Alto, CA or Providence, RI. 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.

Emad N. Eskandar, MD
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.

Ben Walter, MD
Principal Investigator – Case Western Reserve University

Dr. Walter is an Assistant Professor of Neurology and Penni and Stephen Weinberg Master Clinician in Brain Health at Case Western Reserve University School of Medicine, Director of the Movement Disorders Division and Medical Director of the Deep Brain Stimulation (DBS) Program at the Movement Disorders Center at University Hospitals - Case Medical Center.

Jonathan Miller, MD
Surgical Investigator – Case Western Reserve University

Dr. Miller is an Associate Professor of Neurological Surgery, Director of the Functional and Restorative Neurosurgery Center, and the George R. and Constance P. Lincoln Endowed Chair at University Hospitals Case Medical Center and Case Western Reserve University School of Medicine. He received his MD from Case Western Reserve University School of Medicine in 2002, where he also completed neurosurgery residency. He completed a fellowship in Functional and Stereotactic Neurosurgery at Oregon Health Science University in 2007.

Jennifer Sweet, MD
Surgical Co-Investigator

Dr. Sweet is an Assistant Professor of Neurological Surgery at Case Western Reserve University School of Medicine and Attending Neurosurgeon at the Department of Neurological Surgery, University Hospitals Case Medical Center. Dr. Sweet received her MD from Georgetown University School of Medicine. She underwent a Neurosurgical residency at George Washington University, followed by a Stereotactic and Functional Neurosurgery Fellowship at University Hospitals Case Medical Center.

Stephen Mernoff, MD
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 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.

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Partner Institutions

Brown Case Western Reserve University MGH Stanford School of Medicine DVA