Article Text

Motor neuroprosthesis implanted with neurointerventional surgery improves capacity for activities of daily living tasks in severe paralysis: first in-human experience
  1. Thomas J Oxley1,2,
  2. Peter E Yoo1,2,
  3. Gil S Rind1,2,
  4. Stephen M Ronayne1,2,
  5. C M Sarah Lee3,
  6. Christin Bird1,
  7. Victoria Hampshire2,
  8. Rahul P Sharma4,
  9. Andrew Morokoff1,5,
  10. Daryl L Williams6,
  11. Christopher MacIsaac7,
  12. Mark E Howard8,
  13. Lou Irving9,
  14. Ivan Vrljic10,
  15. Cameron Williams10,
  16. Sam E John1,11,
  17. Frank Weissenborn1,12,
  18. Madeleine Dazenko3,
  19. Anna H Balabanski13,
  20. David Friedenberg14,
  21. Anthony N Burkitt11,
  22. Yan T Wong15,
  23. Katharine J Drummond1,5,
  24. Patricia Desmond1,10,
  25. Douglas Weber16,
  26. Timothy Denison2,17,
  27. Leigh R Hochberg18,
  28. Susan Mathers3,
  29. Terence J O'Brien1,13,
  30. Clive N May12,
  31. J Mocco19,
  32. David B Grayden11,
  33. Bruce C V Campbell20,21,
  34. Peter Mitchell10,
  35. Nicholas L Opie1,2
  1. 1Vascular Bionics Laboratory, Departments of Medicine, Neurology and Surgery, Melbourne Brain Centre at the Royal Melbourne Hospital, The University of Melbourne, Melbourne, Victoria, Australia
  2. 2Synchron, Inc, Campbell, California, USA
  3. 3Neurology, Calvary Health Care Bethlehem, South Caulfield, Victoria, Australia
  4. 4Interventional Cardiology, Cardiovascular Medicine Faculty, Stanford University, Stanford, California, USA
  5. 5Neurosurgery, Melbourne Health, Parkville, Victoria, Australia
  6. 6Anaesthesia, Melbourne Health, Parkville, Victoria, Australia
  7. 7Intensive Care Unit, Melbourne Health, Parkville, Victoria, Australia
  8. 8Institute for Breathing and Sleep, Austin Health, Heidelberg, Victoria, Australia
  9. 9Respiratory Medicine, Melbourne Health, Parkville, Victoria, Australia
  10. 10Radiology, Melbourne Health, Parkville, Victoria, Australia
  11. 11Department of Biomedical Engineering, University of Melbourne, Melbourne, Victoria, Australia
  12. 12Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia
  13. 13Neurology, Melbourne Health, Parkville, Victoria, Australia
  14. 14Battelle Memorial Institute, Columbus, Ohio, USA
  15. 15Department of Electrical and Computer Systems Engineering, Monash University, Clayton, Victoria, Australia
  16. 16Department of Mechanical Engineering and Neuroscience Institute, Carnegie Mellon University, Pittsburgh, Pennsylvania, USA
  17. 17Institute of Biomedical Engineering, Oxford University, Oxford, Oxfordshire, UK
  18. 18Center for Neurotechnology and Neurorecovery, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Harvard University, Cambridge, Massachusetts, USA
  19. 19Neurosurgery, The Mount Sinai Health System, New York, New York, USA
  20. 20Medicine, University of Melbourne, Parkville, Victoria, Australia
  21. 21Neurology, Royal Melbourne Hospital, Melbourne, Victoria, Australia
  1. Correspondence to Dr Thomas J Oxley, Vascular Bionics Laboratory, Departments of Medicine, Neurology and Surgery, Melbourne Brain Centre at the Royal Melbourne Hospital, The University of Melbourne, Melbourne, VIC 3050, Australia; thomas.oxley{at}unimelb.edu.au

Abstract

Background Implantable brain–computer interfaces (BCIs), functioning as motor neuroprostheses, have the potential to restore voluntary motor impulses to control digital devices and improve functional independence in patients with severe paralysis due to brain, spinal cord, peripheral nerve or muscle dysfunction. However, reports to date have had limited clinical translation.

Methods Two participants with amyotrophic lateral sclerosis (ALS) underwent implant in a single-arm, open-label, prospective, early feasibility study. Using a minimally invasive neurointervention procedure, a novel endovascular Stentrode BCI was implanted in the superior sagittal sinus adjacent to primary motor cortex. The participants undertook machine-learning-assisted training to use wirelessly transmitted electrocorticography signal associated with attempted movements to control multiple mouse-click actions, including zoom and left-click. Used in combination with an eye-tracker for cursor navigation, participants achieved Windows 10 operating system control to conduct instrumental activities of daily living (IADL) tasks.

Results Unsupervised home use commenced from day 86 onwards for participant 1, and day 71 for participant 2. Participant 1 achieved a typing task average click selection accuracy of 92.63% (100.00%, 87.50%–100.00%) (trial mean (median, Q1–Q3)) at a rate of 13.81 (13.44, 10.96–16.09) correct characters per minute (CCPM) with predictive text disabled. Participant 2 achieved an average click selection accuracy of 93.18% (100.00%, 88.19%–100.00%) at 20.10 (17.73, 12.27–26.50) CCPM. Completion of IADL tasks including text messaging, online shopping and managing finances independently was demonstrated in both participants.

Conclusion We describe the first-in-human experience of a minimally invasive, fully implanted, wireless, ambulatory motor neuroprosthesis using an endovascular stent-electrode array to transmit electrocorticography signals from the motor cortex for multiple command control of digital devices in two participants with flaccid upper limb paralysis.

  • technology
  • vein
  • intervention
  • device
  • brain
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Footnotes

  • Twitter @tomoxl

  • TJO, PEY and NLO contributed equally.

  • Correction notice This article has been corrected since it was published Online First. The competing interest statement was updated.

  • Contributors Clinical trial screening and recruitment: CB, SL, SM, BC, PM. Neurointervention procedure: PM, AM, DLW, CW, IV. Peri-procedural care: BC, PM, AM, CMSL, DLW, AB, MEH, LI, SW, SMR, KD, PD. Experimental design: TJO, NO, PEY, LH, JM, AM, PM, DLW, SEJ, TD, TO’B, DG, AB, CNM, GR, SRR, VH, RPS. Preclinical data collection: NO, TJO, GR, SRR, PEY, SEJ, PM, AM, FW, CNM. Clinical data collection: PEY, PM, AM, BC, CB, AHB, CMSL, DW, IV. Data analysis: NO, PEY, DF, YW, GR, SMR, TJO, TD, SEJ, DG, AB. Manuscript drafting: PEY, TJO, NO, CB, AB. All authors reviewed and edited the manuscript. Authors TJO, PEY and NO contributed equally to this article.

  • Funding This work was supported by research grants from US Defense Advanced Projects Agency (DARPA) Microsystems Technology Office contract N6601-12-1-4045; Office of Naval Research (ONR) Global N26909-14-1-N020; USA Department of Defense Office of the Congressionally Directed Medical Research Programs (CDMRP), SC160158; Office of the Assistant Secretary of Defense for Health Affairs, Spinal Cord Injury Award Program W81XWH-17-1-0210; National Health and Medical Research Council of Australia (NHMRC) Grants GNT1161108, GNT1062532, GNT1138110; Australia Research Council (ARC) Linkage Grant LP150100038; Australian Federal Government, Department of Industry, Innovation and Science, GIL73654; Motor Neurone Disease Research Institute of Australia, GIA1844, Global Innovation Linkage Program, Australian Federal Government; and Synchron Inc. contributed to device fabrication.

  • Competing interests TJO reports stock options from Synchron, during the conduct of the study; in addition, TJO has a patent sensing or stimulating activity of tissue issued, and a patent sensing or stimulating activity of tissue pending. PEY reports stock options from Synchron, during the conduct of the study; in addition, PEY has a patent sensing or stimulating activity of tissue issued, and a patent sensing or stimulating activity of tissue pending. GSR reports stock options from Synchron, during the conduct of the study; in addition, GSR has a patent sensing or stimulating activity of tissue issued, and a patent sensing or stimulating activity of tissue pending. SMR reports stock options from Synchron, during the conduct of the study; in addition, SMR has a patent sensing or stimulating activity of tissue issued, and a patent sensing or stimulating activity of tissue pending. RPS reports stock options from Synchron, during the conduct of the study. VH reports personal fees from Synchron, during the conduct of the study. LRH reports that The Massachusetts General Hospital (MGH) Translational Research Center (TRC) has clinical research support agreements with Synchron, Paradromics and Neuralink, for which LRH provides consultative input. TD reports personal fees from Synchron, during the conduct of the study. JM reports stock options from Synchron, during the conduct of the study. NLO reports stock options from Synchron, during the conduct of the study; in addition, NLO has a patent sensing or stimulating activity of tissue issued, and a patent sensing or stimulating activity of tissue pending.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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