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The Effects of Closed-Loop Brain Implants on Autonomy and Deliberation: What are the Risks of Being Kept in the Loop?

  • FREDERIC GILBERT, TERENCE O’BRIEN and MARK COOK

Abstract:

A new generation of implantable brain–computer interfaces (BCI) devices have been tested for the first time in a human clinical trial, with significant success. These intelligent implants detect specific neuronal activity patterns, such as an epileptic seizure, and provide information to help patients to respond to the upcoming neuronal events. By forecasting a seizure, the technology keeps patients in the decisional loop; the device gives control to patients on how to respond and decide on a therapeutic course ahead of time. Being kept in the decisional loop can positively increase patients’ quality of life; however, doing so does not come free of ethical concerns. There is currently a lack of evidence concerning the various impacts of closed-loop system BCIs on patients’ decisionmaking processes, especially how being in the decisional loop impacts patients’ sense of autonomy. This article addresses these gaps by providing data that we obtained from a first-in-human clinical trial involving patients implanted with advisory brain devices. This article explores ethical issues related to the risks involved in being kept in the decisional loop.

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Notes

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2. Please refer to “Food and Drug Administration” approval letter “p100026a.” The approval letter can be found through the FDA search engine located on their website fda.com. Simply search for “p100026a” in the search engine to access the approval letter. http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100026a.pdf (last accessed 13 Oct 2017).

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7. See note 5, Kellmeyer et al. 2016.

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9. See note 5, Kellmeyer et al. 2016.

10. See note 6, Goering et al. 2017.

11. In theory, this generation of BCI devices could be used to automate drug delivery so as to avoid unwanted outcomes. See notes 12–14.

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15. See note 3, Cook et al. 2013.

16. See note 5, Kellmeyer et al. 2016.

17. See note 6, Goering et al. 2017.

18. This study was conducted in accordance with Tasmanian Human Research Ethics Committee regulations. Patient Consent and Minimal Risk Ethics Application Approval, entitled “(H0013883) Implantable Seizure Advisory Brain Devices: Ethical Implications” is in compliance with the Tasmanian Human Research Ethics Committee regulations. Initial ethics approval was obtained in March 2013, and an amendment was approved in November 2014.

19. Interviews consisted in following a semi-structured script with a duration average of 45 minutes per patient. Open questions such as: “how was it to live with/out the device” or “how did you experienced device prediction” were asked. Following patients’ answers, we followed up on some key themes or concepts introduced by patients. This qualitative approach allowed us to capture first-personal perspectives that are not identified by standardized questionnaires and scales.

20. See note 3, Cook et al. 2013.

21. Here, Kermit the frog is an aura. An aura is a physiological phenomenon experienced by some patients, which announces an upcoming epileptic seizure.

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23. See note 3, Cook et al. 2013.

24. We discuss further the phenomenology of postoperative malaise in the references cited in notes 25 and 26.

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30. See note 29, Gilbert 2015.

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40. See note 29, Gilbert 2015.

41. See note 32, Palacios-Gonzalez 2015.

42. See note 33, Brown 2015.

43. See note 34, Klein 2015.

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Neuroethics Now welcomes articles addressing the ethical application of neuroscience in research and patient care, as well as its impact on society.

This work was supported by grants from the Australian Research Council (DECRA award project number DE150101390) and the National Science Foundation (NSF Award #EEC-1028725). Funding from the Australian Research Council Centre of Excellence Scheme (Project Number CE 140100012) is gratefully acknowledged. In addition, we thank the Cambridge Quarterly of Healthcare Ethics editor and reviewers, Tim Krahn, and the neuroethics team at the University of Washington for their valuable comments. Dr. Gilbert’s ORCID number is 0000-0003-0524-8649.

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