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Updated: Aug 14, 2025
An Experimental Platform to Study the Closed-loop Performance of Brain-machine Interfaces
Published on: March 10, 2011
Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System
Daniel B Rubin1, A Bolu Ajiboye2, Laurie Barefoot2
1From the Center for Neurotechnology and Neurorecovery (CNTR) (D.B.R., L.B., S.S.C., C.G., R.M., M.M., L.R.H.), Department of Neurology, and Department of Neurosurgery (Z.M.W.), Massachusetts General Hospital, Boston; Harvard Medical School (D.B.R., S.S.C., L.R.H.), Boston, MA; Department of Biomedical Engineering (A.B.A., R.F.K.), Case Western Reserve University, Cleveland, OH; FES Center of Excellence, Rehab. R&D Service (A.B.A., R.F.K., J.P.M., J.A.S., B.L.W.), Louis Stokes Cleveland Department of Veterans Affairs Medical Center, OH; Center for Neurorestoration and Neurotechnology (CfNN) (M.B., J.P.D., J.D.S., L.R.H.), Rehabilitation R&D Service, Department of Veterans Affairs Medical Center, Providence, RI; Legs and Walking Lab (D.C.), Shirley Ryan AbilityLab, Chicago, IL; Department of Physical Medicine and Rehabilitation (D.C.), Northwestern University Feinberg School of Medicine, Rehabilitation Institute of Chicago, IL; Department of Neuroscience (J.P.D.), Robert J. and Nancy D. Carney Institute for Brain Science (J.P.D., J.D.S., L.R.H.), School of Engineering (J.P.D., J.D.S., L.R.H.), and Department of Rehabilitation Medicine (J.A.M.), Brown University, Providence, RI; Department of Neurological Surgery (E.N.E.), Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; European University of Cyprus (G.F.), Nicosia, Cyprus; Department of Neurosurgery (J.M.H.), Stanford University School of Medicine, CA; Wu Tsai Neurosciences Institute (J.M.H., K.V.S.), Bio-X Institute (J.M.H., K.V.S.), and Departments of Neurobiology (K.V.S.), Electrical Engineering (K.V.S.), and Bioengineering (K.V.S.), Stanford University, CA; Department of Neurological Surgery (R.F.K., J.P.M., J.A.S.), University Hospitals Case Medical Center, Cleveland, OH; Neurology Section (S.T.M.), VA Providence Health Care System, Providence, RI; Department of Neurology (S.T.M.), Alpert Medical School of Brown University, Providence, RI; Sargent Rehabilitation Center (J.A.M.), Warwick, RI; Section of Neurosurgery (R.D.P.), Department of Surgery, University of Chicago; Department of Neurosurgery (R.D.P.), Rush University Medical Center, Chicago, IL; Department of Neurology (J.S.), Barrow Neurological Institute, Phoenix, AZ; Howard Hughes Medical Institute at Stanford University (K.V.S.); Center for Neurological Restoration (B.L.W.), Cleveland Clinic, OH; and Program in Neuroscience (Z.M.W.), Harvard-MIT Program in Health Sciences and Technology, Harvard Medical School, Boston, MA. drubin4@mgh.harvard.edu.
Background And Objectives:
Brain-computer interfaces (BCIs) are being developed to restore mobility, communication, and functional independence to people with paralysis. Though supported by decades of preclinical data, the safety of chronically implanted microelectrode array BCIs in humans is unknown. We report safety results from the prospective, open-label, nonrandomized BrainGate feasibility study (NCT00912041), the largest and longest-running clinical trial of an implanted BCI.
Methods:
Adults aged 18-75 years with quadriparesis from spinal cord injury, brainstem stroke, or motor neuron disease were enrolled through 7 clinical sites in the United States. Participants underwent surgical implantation of 1 or 2 microelectrode arrays in the motor cortex of the dominant cerebral hemisphere. The primary safety outcome was device-related serious adverse events (SAEs) requiring device explantation or resulting in death or permanently increased disability during the 1-year postimplant evaluation period. The secondary outcomes included the type and frequency of other adverse events and the feasibility of the BrainGate system for controlling a computer or other assistive technologies.
Results:
From 2004 to 2021, 14 adults enrolled in the BrainGate trial had devices surgically implanted. The average duration of device implantation was 872 days, yielding 12,203 days of safety experience. There were 68 device-related adverse events, including 6 device-related SAEs. The most common device-related adverse event was skin irritation around the percutaneous pedestal. There were no safety events that required device explantation, no unanticipated adverse device events, no intracranial infections, and no participant deaths or adverse events resulting in permanently increased disability related to the investigational device.
Discussion:
The BrainGate Neural Interface system has a safety record comparable with other chronically implanted medical devices. Given rapid recent advances in this technology and continued performance gains, these data suggest a favorable risk/benefit ratio in appropriately selected individuals to support ongoing research and development.
Trial Registration Information:
ClinicalTrials.gov Identifier: NCT00912041.
Classification Of Evidence:
This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs defined as those requiring device explantation, resulting in death, or resulting in permanently increased disability during the 1-year postimplant period.
