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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?

Published online by Cambridge University Press:  06 March 2018

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.

Type
Departments and Columns
Copyright
Copyright © Cambridge University Press 2018 

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References

Notes

1. Morrell MJ, RNS System in Epilepsy Study Group. Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology 2011;77(13):1295–304.

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).

3. Cook, M, O’Brien, TJ, Berkovic, SF, Murphy, M, Morokoff, A, Fabinyi, G, et al. Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: A first-in-man study. Lancet Neurology 2013;12(6):563–71.Google Scholar

4. Kingwell, K. Implantable device advises patients with epilepsy of seizure likelihood. Nature Reviews Neurology 2013;9:297.CrossRefGoogle ScholarPubMed

5. Kellmeyer, P, Cohcrane, T, Müller, O, Mitchell, C, Ball, T, Fins, JJ, et al. Effects of closed-loop medical devices on the autonomy and accountability of persons and systems. Cambridge Quarterly of Heathcare Ethics 2016;25(4):623–33.CrossRefGoogle ScholarPubMed

6. Goering, S, Klein, E, Dougherty, D, Wildge, AS. Staying in the loop: Relational agency and identity in next generation DBS for psychiatry. American Journal of Bioethics Neuroscience 2017;8(2):5970.Google Scholar

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

8. Glannon, W, Ineichen, C. Philosophical aspects of closed-loop neuroscience. In: El Hady, A, ed. Closed Loop Neuroscience. London: Elsevier; 2016:259–70.Google Scholar

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.

12. World-first epilepsy treatment delivers promising trial results in Victoria, December 14, 2016; available at http://www.abc.net.au/news/2016-12-15/world-first-trial-for-new-epilepsy-producing-promising-results/8122668 (last accessed 8 Mar 2017).

13. Halliday, AJ, Cook, MJ. Polymer-based drug delivery devices for neurological disorders. CNS and Neurological Disorders Drug Targets 2009;8:205–21.Google Scholar

14. Yue, Z, Moulton, SE, Cook, M, O’Leary, S, Wallace, GG. Controlled delivery for neuro-bionic devices. Advanced Drug Delivery Reviews 2013;65(4):559–69.CrossRefGoogle ScholarPubMed

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.

22. Sullivan, LS, Do implanted brain devices threaten autonomy or the “sense” of autonomy? AJOB Neuroscience 2015;6(4):24–6.CrossRefGoogle Scholar

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.

25. Gilbert F, Deep brain stimulation: inducing self-estrangement. Neuroethics 2017 (Online first May 2017) Available at https://doi.org/10.1007/s12152-017-9334-7 (last accessed 31 Oct 2017).

26. Gilbert, F, Goddard, E, Viaña, JMN, et al. I miss being me: Phenomenological effects of deep brain stimulation. AJOB Neuroscience 2017;8(2):96109.Google Scholar

27. Hainz, T. Broad consent and the implantation of predictive brain technologies. AJOB Neuroscience 2015;6(4):20–2.Google Scholar

28. Klein, E, Goering, S, Gagne, J, et al. Brain-computer interface-based control of closed-loop brain stimulation: Attitudes and ethical considerations. Brain-Computer Interfaces 2016;3(3):19.CrossRefGoogle Scholar

29. Gilbert, F. A Threat to autonomy: The intrusion of predictive brain implants. AJOB Neuroscience 2015;6(4):411.Google Scholar

30. See note 29, Gilbert 2015.

31. Danaher J. The ethics of algorithmic outsourcing: An analysis, 2016; available at http://philosophicaldisquisitions.blogspot.com.au/2016/06/the-ethics-of-algorithmic-outsourcing.html (last accessed 16 Oct 2017).

32. Palacios-Gonzalez C. Epilepsy, decisional vulnerability, and the nature of predictive brain implants, AJOB Neuroscience 2015;6(4):18–20.

33. Brown, T. A relational take on advisory brain implant systems. AJOB Neuroscience 2015;6(4):46–8.CrossRefGoogle Scholar

34. Klein, E. Are brain-computer interface (BCI) devices a form of internal coercion? AJOB Neuroscience 2015;6(4):32–4.CrossRefGoogle Scholar

35. Langston, RF, Ainge, JA, Couey, JJ, Canto, CB, Bjerknes, TL, Witter, MP, et al. Space and direction are already represented in specific neurons when rat pups navigate a location for the first time. Science 2010;328(5985):1576–80.Google Scholar

36. Giordano J. Conditions for consent to the use of neurotechnology: A preparatory neuroethical approach to risk assessment and reduction. AJOB Neuroscience 2015;6(4):12–4.

37. Goering S. Stimulating autonomy: DBS and the prospect of choosing to control ourselves through stimulation. AJOB Neuroscience 2015;6(4):1–3.

38. Gilbert F, Cook M. Are predictive brain implnats an indispensable feature of autonomy? Bioethica Forum 2015;8(4):121–7.

39. Trafimow D. Predictive brain implants are unlikely to decrease patients’ autonomy. AJOB Neuroscience 2015;6(4):22–4.

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.

44. Viaña JMN, Vickers JC, Cook MJ, Gilbert F. Currents of memory: Recent progress, translational challenges, and ethical considerations in fornix deep brain stimulation trials for Alzheimer’s disease. Neurobiology of Aging 2017 [Epub ahead of print].

45. Gilbert F. Self-estrangement and deep brain stimulation: Ethical issues related to forced explantation Neuroethics 2015;8(2):107–14.

46. Viaña JMN, Bittlinger MA, Gilbert F. Ethical considerations for deep brain stimulation trials in patients with early-onset Alzheimer’s disease. Journal of Alzheimer’s Disease 2017;58(2):289–301.

47. Gilbert F. Deep brain stimulation for treatment resistant depression: Postoperative feelings of self-estrangement, suicide attempt and impulsive-aggressive behaviours. Neuroethics 2013;6(3):473–81.

48. Bretzner F, Gilbert F, Baylis F, Brownstone R. Target populations for first-in-human embryonic stem cell research in spinal cord injury, Cell Stem Cell 2011;8:468–75.

49. Gilbert F, Harris A, Kapsa R. Controlling brain cells with light: Ethical considerations for optogenetics trials. AJOB Neuroscience 2014;5(3):3–11.

50. Gilbert F, Vranic A. Pedophilia, invasive brain intervention and punishment. Journal of Bioethical Inquiry 2015;12(3):521–6.

51. Vranic A, Gilbert F. Prognostics implication of preoperative behavior changes in patients with high-grade meningiomas, The Scientific World Journal 2014;Article ID 398295, 5 pages. Available at http://dx.doi.org/10.1155/2014/398295 (last accessed 31 Oct 2017).