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Subject and Family Perspectives from the Central Thalamic Deep Brain Stimulation for Traumatic Brain Injury Study: Part I

Published online by Cambridge University Press:  18 November 2022

Joseph J. Fins Open the ORCID record for Joseph J. Fins [Opens in a new window] ,
Megan S. Wright ,
Jaimie M. Henderson  and
Nicholas D. Schiff
Joseph J. Fins*
Affiliation:
Division of Medical Ethics, Weill Cornell Medical College, New York, New York 10021, USA Solomon Center for Health Law & Policy, Yale Law School, New Haven, Connecticut 06511, USA
Megan S. Wright
Affiliation:
Division of Medical Ethics, Weill Cornell Medical College, New York, New York 10021, USA Pennsylvania State University, Penn State Law, University Park, Pennsylvania 16802, USA
Jaimie M. Henderson
Affiliation:
Department of Neurosurgery, Stanford School of Medicine, Stanford, California 94305, USA
Nicholas D. Schiff
Affiliation:
Division of Medical Ethics, Weill Cornell Medical College, New York, New York 10021, USA Feill Family Brain and Mind Research Institute, Weill Cornell Medical College, New York, New York 10065, USA
*
*Corresponding author. Email: jjfins@med.cornell.edu
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Abstract

This is the first article in a two-part series describing subject and family perspectives from the central thalamic deep brain stimulation for the treatment of traumatic brain injury using the Medtronic PC + S first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury, with subjects who were deemed capable of providing voluntary informed consent. In this article, we report on interviews conducted prior to surgery wherein we asked participants about their experiences recovering from brain injury and their perspectives on study enrollment and participation. We asked how risks and benefits were weighed, what their expectations and fears were, and how decisions were reached about trial participation. We found that informed consent and enrollment decisions are fraught. Subjects and families were often split, with subjects more focused on putative benefits and families concerned about incremental risk. Both subjects and families viewed brain injury as disruptive to personal identity and relationships. As decisions were made about study enrollment, families struggled with recognizing the re-emergent agency of subjects and ceding decision-making authority to subjects who had previously been dependent upon them for protection and guidance. Subjects and family members reported a hope for the relief of cognitive disabilities, improved quality of life, normalization of interpersonal interactions, and a return to work or school as reasons for study participation, along with altruism and a desire to advance science. Despite these aspirations, both subjects and families appreciated the risks of the intervention and did not suffer from a therapeutic misconception. A second essay to be published in the next issue of Cambridge Quarterly of Healthcare Ethics—Clinical Neuroethics will describe interviews conducted after surgery, the effects of cognitive restoration for subjects, families, and challenges presented to the social structures they will call upon to support them through recovery. This subsequent article will be available online prior to its formal publication in October 2023.

Keywords

brain injurydeep brain stimulationcognitive restorationnarrativesneuroethicsdisability rights
Type
Research Article
Information
Cambridge Quarterly of Healthcare Ethics , Volume 31 , Issue 4 , October 2022 , pp. 419 - 443
Copyright
© The Author(s), 2022. Published by Cambridge University Press

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References

Notes

1. Hammond, FM, Malec, JF, Corrigan, JD, Whiteneck, GG, Hart, T, Dams-O’Connor, K, et al. Patterns of functional change five to ten years after moderate-severe traumatic brain injury. Journal of Neurotrauma 2021;38(11):1526–34.CrossRefGoogle ScholarPubMed

2. Dikmen, SS, Machamer, JE, Powell, JM, Temkin, NR. Outcome 3 to 5 years after moderate to severe traumatic brain injury. Archives of Physical Medicine and Rehabilitation 2003;84(10):1449–57CrossRefGoogle ScholarPubMed.

3. National Academies of Sciences, Engineering, and Medicine. Traumatic Brain Injury: A Roadmap for Accelerating Progress. Washington, DC: The National Academies Press; 2022; available at https://www.nap.edu/catalog/25394 (last accessed 2 Jun 2022).

4. Schiff ND, Giacino JT, Butson CR, Baker JL, Bergin M, Bronte-Stewart HM, et al. Central thalamic brain stimulation improves executive function and fatigue in patients with severe to moderate traumatic brain injury; in preparation.

5. Wong JK, Deuschl G, Wolke R, Bergman H, Muthuraman M, Groppa S, et al. Proceedings of the ninth annual deep brain stimulation think tank: Advances in cutting edge technologies, artificial intelligence, neuromodulation, neuroethics, pain, interventional psychiatry, epilepsy, and traumatic brain injury. Frontiers in Human Neuroscience 2022;16:813387.

6. Appelbaum, PS, Roth, LH, Lidz, C. The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry 1982;5:319–29CrossRefGoogle ScholarPubMed.

7. All participants who consented to be interviewed are human subjects in our IRB approved study. For the sake of clarity, we will designate participants who were implanted with deep stimulators as “subjects” and others as “family members.” We define “family member” as both biological and chosen, including for one subject a close friend. We have deleted respondent names and placed a substitute pronoun in brackets.

8. Fox, RC. The Sociology of Medicine: A Participant Observer’s View. Englewood Cliffs, NJ: Prentice Hall; 1989 Google Scholar.

9. Fins JJ. Omicron, the legacy of Renée Fox, and the uncertain practice of medicine. Hastings Center Bioethics Forum; 2021 Dec 1; available at https://www.thehastingscenter.org/omicron-and-uncertainty-in-medicine/ (last accessed 15 Apr 2022).

10. Fox RC. Moving bioethics towards its better self. Perspectives in Biology and Medicine 2016;59(1):46–54.

11. Parens, E. Shaping Our Selves: On Technology, Flourishing and a Habit of Thinking. Oxford: Oxford University Press; 2015 Google Scholar.

12. Fins JJ, Wright MS. The dignity of risk, reemergent agency, and the central thalamic stimulation trial for moderate to severe brain injury. Invited submission, Perspectives in Biology and Medicine; in press.

13. Benabid, AL, Pollak, P, Louveau, , Henry, S, de Rougemont, J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Applied Neurophysiology 1987;50(1–6):344–6Google ScholarPubMed.

14. Gildenberg, Philip L. The history of surgery for movement disorders. Neurosurgery Clinics of North America 1998;9(2):283–94Google ScholarPubMed. PMID: 9495891.

15. DeLong, M, Benabid, AL. Discovery of high-frequency deep brain stimulation for treatment of Parkinson’s Disease: 2014 Lasker Award. JAMA 2014;312(11):1093–4Google ScholarPubMed.

16. Mayberg, HS, Lozano, AM, Voon, V, McNeely, HE, Seminowicz, D, Hamani, C, et al. Deep brain stimulation for treatment-resistant depression. Neuron 2005;45(5):651–60CrossRefGoogle ScholarPubMed.

17. Nuttin, B, Cosyns, P, Demeulemeester, H, Gybels, J, Meyerson, B. Electrical stimulation in anterior limbs of internal capsules in patients with obsessive–compulsive disorder. Lancet 1999;354(9189):1526 CrossRefGoogle ScholarPubMed.

18. Schiff, ND, Giacino, JT, Kalmar, K, Victor, JD, Baker, K, Gerber, M, et al. Behavioral improvements with thalamic stimulation after severe traumatic brain injury. Nature 2007;448(7153):600–3CrossRefGoogle ScholarPubMed.

19. Giacino, JT, Ashwal, S, Childs, N, Cranford, R, Jennett, B, Katz, DI, et al. The minimally conscious state: definition and diagnostic criteria. Neurology 2002;58(3):349–53CrossRefGoogle ScholarPubMed.

20. Schiff, ND. Recovery of consciousness after brain injury: A mesocircuit hypothesis Trends in Neuroscience 2010;33(1):1–9 CrossRefGoogle Scholar.

21. See note 18, Schiff et al. 2007.

22. Schiff, ND, Fins, JJ. Deep brain stimulation and cognition: Moving from animal to patient. Current Opinion in Neurology 2007;20(6):638–42CrossRefGoogle ScholarPubMed.

23. Fins, JJ. Rights Come to Mind: Brain Injury, Ethics, and the Struggle for Consciousness. New York: Cambridge University Press; 2015 CrossRefGoogle Scholar.

24. See note 23, Fins 2015.

25. Dubiel, H. Deep in the Brain: Living with Parkinson’s Disease. Schmitz, P, Translator. New York: Europa Editions; 2009 Google Scholar.

26. de Haan, S, Rietveld, E, Stokhof, M, Denys, D. Effects of deep brain stimulation on the lived experience of obsessive–compulsive disorder patients: In-depth interviews with 18 Patients. PLoS One 2015;10(8):e0135524CrossRefGoogle ScholarPubMed.

27. Kraemer, F. Me, myself and my brain implant: Deep brain stimulation raises questions of personal authenticity and alienation. Neuroethics 2013;6:483–97CrossRefGoogle ScholarPubMed.

28. Leykin, Y, Christopher, PP, Holtzheimer, PE, Appelbaum, PS, Mayberg, HS, Lisanby, SH, et al. Participants’ perceptions of deep brain stimulation research for treatment-resistant depression: Risks, benefits, and therapeutic misconception. AJOB Primary Research 2011;2(4):33–41 CrossRefGoogle ScholarPubMed.

29. Nyholm, S, O’Neill, E. Deep brain stimulation, continuity over time, and the true self. Cambridge Quarterly of Healthcare Ethics 2016;25(4):647–58CrossRefGoogle ScholarPubMed.

30. See note 23, Fins 2015.

31. Madden, R. Being Ethnographic: A Guide to the Theory and Practice of Ethnography. Thousand Oaks, CA: Sage; 2010 Google Scholar.

32. Becker, HS. The epistemology of qualitative research. In: Emerson, RM, ed. Contemporary Field Research: Perspectives and Formulations. 2nd ed. Long Grove, IL: Waveland Press; 2001:317–30Google Scholar.

33. ATLAS.ti. Version 7.5 [Computer software] (2016) Berlin, Scientific Software Development.

34. Fielding, NG, Lee, RM. Computer Analysis and Qualitative Research. London: SAGE; 1998 Google Scholar.

35. Charmaz, K. Grounded theory. In: Emerson, RM, ed. Contemporary Field Research: Perspectives and Formulations. 2nd ed. Long Grove, IL: Waveland Press; 2001:335–52Google Scholar.

36. Lonkila, M. Grounded theory as an emerging paradigm for computer-assisted qualitative data analysis. In: Kelle, U, ed. Computer-Aided Qualitative Data Analysis: Theory, Methods, and Practice. 2nd ed. Thousand Oaks, CA: Sage; 1998:41–51 Google Scholar.

37. Strauss, AL, Corbin, J. Basics of Qualitative Research: Grounded Theory Procedures and Techniques. Thousand Oaks, CA: Sage; 1990 Google Scholar.

38. See note 23, Fins 2015.

39. Clark, ME. No more apologies. JAMA 2012;308(19):1983–4CrossRefGoogle ScholarPubMed.

40. Fins, JJ, Hersh, J. Solitary advocates: The severely brain injured and their surrogates. In Hoffman, B, Tomes, N, Schlessinger, M, Grob, R, eds. Transforming Health Care from Below: Patients as Actors in U.S. Health Policy. New Brunswick, NJ: Rutgers University Press; 2011:21–42 Google Scholar.

41. See note 23, Fins 2015.

42. See note 23, Fins 2015.

43. Giovannetti, AM, Černiauskaitė, M, Leonardi, M, Sattin, D, Covelli, V. Informal caregivers of patients with disorders of consciousness: Experience of ambiguous loss. Brain Injury 2015;29(4):473–80Google ScholarPubMed.

44. Braine, ME. The experience of living with a family member with challenging behavior post acquired brain injury. Journal Neuroscience Nursing 2011;43(3):156–64CrossRefGoogle ScholarPubMed.

45. Goodwin, E, Chappell, B, Kreutzer, J. Relationships after TBI: A grounded research study. Brain Injury 2014;28(4):398–413 CrossRefGoogle Scholar.

46. See note 12, Fins & Wright, in press.

47. Fins, JJ. Disorders of consciousness and disordered care: Families, caregivers and narratives of necessity. Archives of Physical Medicine and Rehabilitation 2013;94(10):1934–9CrossRefGoogle ScholarPubMed.

48. See note 23, Fins 2015.

49. Cloute, K, Mitchell, A, Yates, P. Traumatic brain injury and the construction of identity: A discursive approach. Neuropsychological Rehabilitation 2008;18(5–6):651–70CrossRefGoogle ScholarPubMed.

50. Levack, WM, Boland, P, Taylor, WJ, Siegert, RJ, Kayes, NM, Fadyl, JK, et al. Establishing a person-centred framework of self-identity after traumatic brain injury: A grounded theory study to inform measure development. BMJ Open 2014;4(5):e004630CrossRefGoogle ScholarPubMed.

51. All interviews are denoted as [P###] when quoting a subject or family member dyad/triad. Names and some content have been redacted to ensure privacy and maintain confidentiality.

52. Carey B. Doctors use electrical implant to aid brain-damaged woman. The New York Times 2019 Apr 13; available at https://www.nytimes.com/2019/04/13/health/implant-brain-injury.html (last accessed 18 Apr 2022).

53. Schiff ND, Giacino JT, Butson CR, Baker JL, Bergin M, Bronte-Stewart HM, et al. In Fifth Annual Brain Initiative. Investigators Meeting Abstract Book [abstract S-124]. 250 (National Institute of Mental Health, 2019).

54. See note 52, Carey 2019.

55. Leykin, Y, Christopher, PP, Holtzheimer, PE, Appelbaum, PS, Mayberg, HS, Lisanby, SH, et al. Participants’ perceptions of deep brain stimulation research for treatment-resistant depression: Risks, benefits, and therapeutic misconception. AJOB Primary Research 2011;2(4):33–41 CrossRefGoogle ScholarPubMed.

56. Outram S, Muñoz KA, Kostick-Quenet K, Sanchez CE, Kalwani L, Lavingia R, et al. Patient, caregiver, and decliner perspectives on whether to enroll in adaptive deep brain stimulation research. Frontiers in Neuroscience 2021;15:734182.

57. Thomson CJ, Segrave RA, Fitzgerald PB, Richardson KE, Racine E, Carter A. “Nothing to lose, absolutely everything to gain”: Patient and caregiver expectations and subjective outcomes of deep brain stimulation for treatment-resistant depression. Frontiers in Human Neuroscience 2021;15:755276.

58. Kubu, CS, Ford, PJ. Clinical ethics in the context of deep brain stimulation for movement disorders. Archives of Clinical Neuropsychology 2017;32(7):829–39CrossRefGoogle ScholarPubMed.

59. Christopher, PP, Leykin, Y, Appelbaum, PS, Holtzheimer, PE, Mayberg, HS, Dunn, LB. Enrolling in deep brain stimulation research for depression: Influences on potential subjects’ decision making. Depression and Anxiety 2012;29(2):139–46CrossRefGoogle ScholarPubMed.

60. See note 55, Leykin et al. 2011.

61. Fisher, CE, Dunn, LB, Christopher, PP, Holtzheimer, PE, Leykin, Y, Mayberg, HS, et al. The ethics of research on deep brain stimulation for depression: Decisional capacity and therapeutic misconception. Annals New York Academy of Sciences 2012;1265:69–79 CrossRefGoogle ScholarPubMed.

62. See note 52, Carey 2019.

63. Fins, JJ. Mosaic decisionmaking and reemergent agency following severe brain injury. Cambridge Quarterly of Health Care Ethics 2018;27(1):163–74CrossRefGoogle Scholar.

64. Fins, JJ, Pohl, BR. Guardianship and the injured brain: Representation and the rights of patients and families. In: Sinnott-Armstrong, W, ed. Finding Consciousness: The Neuroscience, Ethics, and Law of Severe Brain Injury. New York: Oxford University Press; 2016:246–59CrossRefGoogle ScholarPubMed.

65. See note 52, Carey 2019.

66. See note 22, Fins and Wright. in press.

67. See note 56, Outram et al. 2021.

68. See note 57, Thomson et al. 2021.

69. Wright, MS, Fins, JJ. Regulating post-trial access to in-dwelling class III neural devices. In: Glenn Cohen, I, Minussen, T, Nicholson Price II W, Robertson, C, Shachar, C, eds. The Future of Medical Device Regulation: Innovation and Protection. New York: Cambridge University Press; 2022Google Scholar.

70. Shapiro ZE, Rabkin Golden A, Antill GE, Deb C, Fang K, Clarke E, et al. Designing an Americans with abilities act: Consciousness, capabilities, and civil rights. Boston College Law Review; in press.

71. See note 27, Kraemer et al. 2013 and See note 29, Nyholm and O’Neill 2016 and above discussion on personal identity.