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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.

Neurology
|January 13, 2023
PubMed
Summary

The BrainGate study shows that brain-computer interfaces (BCIs) implanted in humans are safe for restoring function. This research indicates a favorable risk/benefit for individuals with paralysis using BCI technology.

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Area of Science:

  • Neuroscience
  • Biomedical Engineering
  • Clinical Trials

Background:

  • Brain-computer interfaces (BCIs) aim to restore function for individuals with paralysis.
  • The long-term safety of chronically implanted microelectrode array BCIs in humans remains largely unknown.
  • The BrainGate feasibility study is the largest and longest-running clinical trial of an implanted BCI system.

Purpose of the Study:

  • To evaluate the safety of chronically implanted microelectrode array BCIs in humans.
  • To report safety outcomes from the prospective, open-label, nonrandomized BrainGate feasibility study.
  • To assess the feasibility of the BrainGate system for controlling assistive technologies.

Main Methods:

  • Adults aged 18-75 with quadriparesis were enrolled across 7 US clinical sites.
  • Participants underwent surgical implantation of microelectrode arrays in the motor cortex.
  • The primary safety outcome was device-related serious adverse events (SAEs) within 1 year post-implantation.

Main Results:

  • 14 adults were implanted, with an average implantation duration of 872 days, totaling 12,203 days of safety experience.
  • 68 device-related adverse events occurred, including 6 SAEs; the most common was skin irritation.
  • No safety events required device explantation, intracranial infections, participant deaths, or permanently increased disability related to the device.

Conclusions:

  • The BrainGate Neural Interface system demonstrates a safety profile comparable to other chronically implanted medical devices.
  • These findings suggest a favorable risk/benefit ratio for the BrainGate system in appropriately selected individuals.
  • The data support continued research and development of BCI technology for restoring function.