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Neurosurgical Considerations for the Brain Computer Interface

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Handbook of Neuroengineering

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Abstract

Brain Computer Interface (BCI) devices are being developed to restore or improve the function of people suffering with neurological disabilities such as limb paralysis, sensory loss, blindness, deafness, movement disorders, memory loss, loss of speech and epilepsy. BCI technology is advancing rapidly but major challenges remain, such as biocompatibility, developing micro-electrodes which function effectively for many years, maintenance of device hermeticity, improved wireless functionality and the ability to simultaneously stimulate and record from a neural network of thousands or millions of neurons. Non-invasive devices are attractive but are far less capable compared with the spatial or functional resolution of implanted devices.

Engineers need to collaborate with neurosurgeons to develop devices that significantly benefit the patient, are practical to implant with low and acceptable surgical risks, have a record of long-term safety, and can be safely explanted. Neurosurgeons should be involved in the preclinical (animal) testing of prototype devices and they need to understand the technical capability of the BCI and its experimental results to be able to discuss the BCI with the potential recipients and their families so that they can give informed consent.

This chapter describes the neurosurgery/engineering collaboration necessary to successfully develop test and commercialize BCIs and also presents the full range of BCI applications. The ethical considerations concerning the development and application of BCIs will also be presented.

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Abbreviations

AIMD:

Active Implantable Medical Device

ASIC:

Application Specific Integrated Circuit

BCI:

Brain Computer Interfaces

CE:

Conformité Européenne

COI:

Conflict of Interest

CSF:

Cerebral spinal fluid

CT:

Computed Tomography

DBS:

Deep brain stimulation

ECoG:

Electrocorticography

EEG:

Electroencephalogram

FDA:

Food and Drug Administration

HREC:

Human Research Ethics Committee

LGN:

Lateral geniculate nucleus

MRI:

Magnetic Resonance Imaging

NHMRC:

National Health and Medical Research Council (of Australia)

NHP:

Non-human primates

NMPA:

National Medical Products Administration

OCD:

Obsessive compulsive disorder

PPC:

Posterior Parietal Cortex

SSEPs:

Somatosensory evoked potentials

TGA:

Therapeutic Goods Administration (of Australia)

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Author information

Authors and Affiliations

  1. Department of Neurosurgery, The Alfred Hospital, Melbourne, VIC, Australia

    Jeffrey V. Rosenfeld

  2. Department of Surgery, Monash University, Clayton, VIC, Australia

    Jeffrey V. Rosenfeld

  3. Department of Electrical and Computer Systems Engineering, Monash University, Clayton, VIC, Australia

    Jeffrey V. Rosenfeld & Julian Szlawski

  4. Department of Surgery, F. Edward Hébert School of Medicine, Uniformed Services University of The Health Sciences, Bethesda, MD, USA

    Jeffrey V. Rosenfeld

  5. Monash Institute of Medical Engineering (MIME), Monash University, Melbourne, VIC, Australia

    Jeffrey V. Rosenfeld

  6. Departments of Electrical and Computer Systems Engineering, Department of Physiology, Biomedicine Discovery Institute, Monash University, Clayton, VIC, Australia

    Yan Wong

  7. Alfred Hospital, Melbourne, VIC, Australia

    Matthew Gutman

Authors
  1. Jeffrey V. Rosenfeld
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  2. Yan Wong
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  3. Julian Szlawski
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  4. Matthew Gutman
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Corresponding author

Correspondence to Jeffrey V. Rosenfeld .

Editor information

Editors and Affiliations

  1. Singapore Institute for Neurotechnology, National University of Singapore, Singapore, Singapore

    Nitish V. Thakor

Section Editor information

  1. N.1. Institute for Health, National University of Singapore, Singapore, Singapore

    Andrei Dragomir

  2. Department of Biomedical Engineering, University of Houston, Houston, USA

    Andrei Dragomir

Appendix A

Appendix A

1.1 Ethics Application for the Pilot Study of a Bionic Vision Device

figure a

1.2 General Information and Investigator Declaration

Principal Investigator:

I, [Principal Investigator], agree to conduct this clinical trial according to the declaration of Helsinki (2000), International Conference on Harmonisation Good Clinical Practice (ICH-GCP), and to abide by the protocol [Protocol ID]. [The Institution responsible] will conduct the study in strict compliance with this protocol.

On behalf of [The Institution],

[signature]

[Principal Investigator]

Principal Investigator

Associate investigators

[Associate Investigator]

[Associate Investigator]

[Associate Investigator]

A.3 Notes on Human Ethics Applicaitons

  1. (a)

    This is an example of what information is required by a hospital or institutional Human Research Ethics Committee to conduct a first-in-human clinical study of a new neural prosthesis such as a bionic vision device in the brain.

  2. (b)

    The investigators also must sign a Declaration of Compliance with accepted ethical practices.

  3. (c)

    The investigators must also produce a Plain Language Statement for the trial participants so that they can reflect in their own time what the study involves and raise any further questions of the investigators. It is written in language that the participants would easily be able to understand. Great care should be taken in preparing this document. The ethics committee will ensure that it meets the standards required to achieve informed patient consent. The potential risks must be included and explained very clearly.

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Rosenfeld, J.V., Wong, Y., Szlawski, J., Gutman, M. (2022). Neurosurgical Considerations for the Brain Computer Interface. In: Thakor, N.V. (eds) Handbook of Neuroengineering. Springer, Singapore. https://doi.org/10.1007/978-981-15-2848-4_38-1

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  • DOI: https://doi.org/10.1007/978-981-15-2848-4_38-1

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  • Print ISBN: 978-981-15-2848-4

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