Skip to main content

Neurosurgery and Neuroinnovation in the Surgical Suite: The Ethics of Neurostimulation for Severe Obesity

  • Chapter
  • First Online:
Ethics and Clinical Neuroinnovation

Abstract

Innovation has been fundamental to neurosurgical advancements. Neurostimulation as treatment for severe obesity is one such innovation that has garnered much attention and implores several ethical considerations. The first ethical consideration relates to the establishment of trust in the surgeon–patient relationship. As part of this trust-building process, informed consent must be obtained from the patient before any surgical procedure is performed. The patient, however, must have mental capacity. In addition, respect for autonomy makes provisions for circumstances in which a patient may not have capacity to make his or her own medical decisions. Other moral considerations regarding neurostimulation for severe obesity include nonmaleficence, justice, and beneficence. Although the use of surgical instruments inherently causes physical “harm” to patients, religious and cultural considerations may also contribute to a patient’s perception of “harm.” In effort to maximize benefits and minimize harm, distribution of medical resources must be done equitably. Patients with severe obesity who are most in need of neurostimulation oftentimes rely on public or private health insurance to cover their costs. However, most health insurance plans offer coverage to only U.S. Food and Drug Administration-approved indications for neurostimulation. This financial limitation challenges a neurosurgeon’s desire to render care to patients who may benefit most from the therapy. This chapter presents additional ethical considerations pertaining to the use of neurostimulation as treatment for severe obesity—namely, conflict of interest, clinical trial design, implantation of neurostimulation devices in vulnerable populations, preoperative assessments, postoperative tracking, and registries.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 79.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 139.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Goel A, Kothari M. Ethics and neurosurgery. Neurol India. 2006;54(1):11.

    Article  Google Scholar 

  2. Ormond DR, Hadjipanayis CG. The history of neurosurgery and its relation to the development and refinement of the frontotemporal craniotomy. Neurosurg Focus. 2014;36(4):E12.

    Article  Google Scholar 

  3. Rhoton AL Jr. The cerebrum. Anatomy. Neurosurgery. 2007;61(1 Suppl):37–118; discussion 118–9.

    Google Scholar 

  4. Powell MP. Sir Victor Horsley at the birth of neurosurgery. Brain. 2016;139(Pt 2):631–4.

    Article  Google Scholar 

  5. Prestigiacomo CJ. The history of the Journal of Neurosurgery: How the “White Journal” helped in the growth of neurological surgery. J Neurosurg. 2019;131(5):1347–55.

    Google Scholar 

  6. Khan FR, Henderson JM. Deep brain stimulation surgical techniques. Handb Clin Neurol. 2013;116:27–37.

    Article  Google Scholar 

  7. Long DM. Harvey Cushing at Johns Hopkins. Neurosurgery. 1999;45(5):983–9.

    Google Scholar 

  8. Alt KW, Jeunesse C, Buitrago-Téllez CH, Wächter R, Boës E, Pichler SL. Evidence for stone age cranial surgery. Nature. 1997;387(6631):360.

    Article  CAS  Google Scholar 

  9. Barbosa DAN, De Oliveira-Souza R, Monte Santo F, De Oliveira Faria AC, Gorgulho AA, De Salles AAF. The hypothalamus at the crossroads of psychopathology and neurosurgery. Neurosurg Focus. 2017;43(3):E15.

    Article  Google Scholar 

  10. Muzumdar D. Neurosurgery in the past and future: An appraisal. Ann Med Surg. 2012;1:13–5.

    Google Scholar 

  11. Alexander Hughes Bennett (1848–1901): Rickman John Godlee (1849–1925). CA Cancer J Clin. 1974;24(3):169–70.

    Google Scholar 

  12. Wall A, Angelos P, Brown D, Kodner IJ, Keune JD. Ethics in surgery. Curr Probl Surg. 2013;50(3):99–134.

    Article  Google Scholar 

  13. Namm JP, Siegler M, Brander C, Kim TY, Lowe C, Angelos P. History and evolution of surgical ethics: John Gregory to the twenty-first century. World J Surg. 2014;38(7):1568–73.

    Article  Google Scholar 

  14. Marcus HJ, Hughes-Hallett A, Kwasnicki RM, Darzi A, Yang G-Z, Nandi D. Technological innovation in neurosurgery: A quantitative study. J Neurosurg. 2015;123(1):174–81.

    Google Scholar 

  15. Grant RA, Halpern CH, Baltuch GH, O’Reardon JP, Caplan A. Ethical considerations in deep brain stimulation for psychiatric illness. J Clin Neurosci. 2014;21(1):1–5.

    Article  Google Scholar 

  16. Schwalb JM, Hamani C. The history and future of deep brain stimulation. Neurotherapeutics. 2008;5(1):3–13.

    Article  Google Scholar 

  17. Sironi VA. Origin and evolution of deep brain stimulation. Front Integr Neurosci. 2011;5:42.

    Article  Google Scholar 

  18. Pycroft L, Stein J, Aziz T. Deep brain stimulation: An overview of history, methods, and future developments. Brain Neurosci Adv. 2018;2:2398212818816017.

    Google Scholar 

  19. Coffey RJ. Deep brain stimulation devices: A brief technical history and review. Artif Organs. 2009;33(3):208–20.

    Google Scholar 

  20. Gardner J. A history of deep brain stimulation: Technological innovation and the role of clinical assessment tools. Soc Stud Sci. 2013;43(5):707–28.

    Google Scholar 

  21. C.V. de Alim-Louis Benabid (in French). France: Membre de l'Académie des sciences; 2008. https://web.archive.org/web/20131103213212/http://www.academie-sciences.fr/academie/membre/BenabidAL_bio1208.pdf.

  22. Williams R. Alim-Louis Benabid: stimulation and serendipity. Lancet Neurol. 2010;9(12):1152.

    Article  Google Scholar 

  23. FDA. Premarket Approval (PMA) Database: Medtronic Activa Tremor Control System. Silver Spring, MD: U.S. Food and Drug Administration; 2020 [updated April 13, 2020]. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009.

  24. FDA. Humanitarian Device Exemption (HDE) Database: Medtronic Activa Deep Brain Stimulation (DBS) for OCD therapy. Silver Spring, MD: U.S. Food and Drug Administration; 2020 [updated April 13, 2020]. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375533.

  25. FDA. Premarket Approval (PMA) Database: Medtronic Activa Parkinson’s Control System. Silver Spring, MD: U.S. Food and Drug Administration; 2020 [updated April 13, 2020]. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S007.

  26. FDA. Humanitarian Device Exemption (HDE) Database: Medtronic Activa Deep Brain Stimulation (DBS) System for dystonia therapy. Silver Spring, MD: U.S. Food and Drug Administration; 2020 [updated April 13, 2020]. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375511.

  27. Ward ZJ, Bleich SN, Cradock AL, Barrett JL, Giles CM, Flax C, et al. Projected U.S. state-level prevalence of adult obesity and severe obesity. N Engl J Med. 2019;381(25):2440–50.

    Article  Google Scholar 

  28. Andreyeva T, Sturm R, Ringel JS. Moderate and severe obesity have large differences in health care costs. Obes Res. 2004;12(12):1936–43.

    Article  Google Scholar 

  29. Elnahas AI, Jackson TD, Hong D. Management of failed laparoscopic Roux-en-Y gastric bypass. Bariatr Surg Pract Patient Care. 2014;9(1):36–40.

    Google Scholar 

  30. Wu H, Adler S, Azagury DE, Bohon C, Safer DL, Barbosa DAN, et al. Brain-responsive neurostimulation for loss of control eating: Early feasibility study. Neurosurgery. 2020;87(6):1277–88.

    Google Scholar 

  31. Pisapia JM, Halpern CH, Muller UJ, Vinai P, Wolf JA, Whiting DM, et al. Ethical considerations in deep brain stimulation for the treatment of addiction and overeating associated with obesity. AJOB Neurosci. 2013;4(2):35–46.

    Article  Google Scholar 

  32. Halpern CH, Wolf JA, Bale TL, Stunkard AJ, Danish SF, Grossman M, et al. Deep brain stimulation in the treatment of obesity. J Neurosurg. 2008;109(4):625–34.

    Article  Google Scholar 

  33. Ho AL, Sussman ES, Pendharkar AV, Azagury DE, Bohon C, Halpern CH. Deep brain stimulation for obesity: Rationale and approach to trial design. Neurosurg Focus. 2015;38(6):E8.

    Google Scholar 

  34. Formolo DA, Gaspar JM, Melo HM, Eichwald T, Zepeda RJ, Latini A, et al. Deep brain stimulation for obesity: A review and future directions. Front Neurosci. 2019;13:323.

    Google Scholar 

  35. Kumar R, Simpson CV, Froelich CA, Baughman BC, Gienapp AJ, Sillay KA. Obesity and deep brain stimulation: An overview. Ann Neurosci. 2015;22(3):181–8.

    Google Scholar 

  36. Nangunoori RK, Tomycz ND, Oh MY, Whiting DM. Deep brain stimulation for obesity: From a theoretical framework to practical application. Neural Plast. 2016;2016:1–8.

    Google Scholar 

  37. Ferreres AR, Angelos P, Singer EA, Blair PG. Ethical issues in surgical care. Chicago, IL: American College of Surgeons; 2017.

    Google Scholar 

  38. Pellegrini CA, Ferreres A. Surgical Ethics Symposium: Ethical dilemmas in surgical practice. World J Surg. 2014;38(7):1565–6.

    Google Scholar 

  39. ACOG. Ethical considerations for the care of patients with obesity: American College of Obstetricians and Gynecologists (ACOG) Committee Opinion No. 763. Obstet Gynecol. 2019;133(1):e90–e96.

    Google Scholar 

  40. Phelan SM, Burgess DJ, Yeazel MW, Hellerstedt WL, Griffin JM, Van Ryn M. Impact of weight bias and stigma on quality of care and outcomes for patients with obesity. Obes Rev. 2015;16(4):319–26.

    Article  CAS  Google Scholar 

  41. Spahlholz J, Baer N, König H-H, Riedel-Heller SG, Luck-Sikorski C. Obesity and discrimination: A systematic review and meta-analysis of observational studies. Obes Rev. 2016;17(1):43–55.

    Google Scholar 

  42. Wee CC, Davis RB, Huskey KW, Jones DB, Hamel MB. Quality of life among obese patients seeking weight loss surgery: The importance of obesity-related social stigma and functional status. J Gen Intern Med. 2013;28(2):231–8.

    Google Scholar 

  43. Gudzune KA, Beach MC, Roter DL, Cooper LA. Physicians build less rapport with obese patients. Obesity. 2013;21(10):2146–52.

    Article  Google Scholar 

  44. Jaworska A. Advance directives and substitute decision-making: The Stanford Encyclopedia of Philosophy. Stanford, CA: Stanford University; 2009. https://plato.stanford.edu/entries/advance-directives/.

  45. Hanson M, Pitt D. Informed consent for surgery: Risk discussion and documentation. Can J Surg. 2017;60(1):69–70.

    Google Scholar 

  46. Umansky F, Black PL, DiRocco C, Ferrer E, Goel A, Malik GM, et al. Statement of ethics in neurosurgery of the World Federation of Neurosurgical Societies. World Neurosurg. 2011;76(3):239–47.

    Google Scholar 

  47. Hotopf M. The assessment of mental capacity. Clin Med. 2005;5(6):580–4.

    Article  Google Scholar 

  48. Biffl WL, Spain DA, Reitsma AM, Minter RM, Upperman J, Wilson M, et al. Responsible development and application of surgical innovations: A position statement of the Society of University Surgeons. J Am Coll Surg. 2008;206(6):1204–9.

    Google Scholar 

  49. Angelos P. The ethical challenges of surgical innovation for patient care. Lancet. 2010;376(9746):1046–7.

    Article  Google Scholar 

  50. OU. Health management, ethics and research module: 7. Principles of healthcare ethics.: The Open University (OU); n.d. https://www.open.edu/openlearncreate/mod/oucontent/view.php?id=225&printable=1.

  51. Lennerz B, Lennerz JK. Food addiction, high-glycemic-index carbohydrates, and obesity. Clin Chem. 2018;64(1):64–71.

    Article  CAS  Google Scholar 

  52. Beaver JD, Lawrence AD, van Ditzhuijzen J, Davis MH, Woods A, Calder AJ. Individual differences in reward drive predict neural responses to images of food. J Neurosci. 2006;26(19):5160–6.

    Article  CAS  Google Scholar 

  53. Volkow ND, Fowler JS, Wang GJ, Baler R, Telang F. Imaging dopamine's role in drug abuse and addiction. Neuropharmacology. 2009;56:3–8.

    Article  CAS  Google Scholar 

  54. Harat M, Rudaś M, Zieliński P, Birska J, Sokal P. Nucleus accumbens stimulation in pathological obesity. Neurol Neurochir Pol. 2016;50(3):207–10.

    Article  Google Scholar 

  55. Mantione M, van de Brink W, Schuurman PR, Denys D. Smoking cessation and weight loss after chronic deep brain stimulation of the nucleus accumbens: Therapeutic and research implications: Case report. Neurosurgery. 2010;66(1):E218.

    Google Scholar 

  56. Tronnier VM, Rasche D, Thorns V, Alvarez-Fischer D, Münte TF, Zurowski B. Massive weight loss following deep brain stimulation of the nucleus accumbens in a depressed woman. Neurocase. 2018;24(1):49–53.

    Article  Google Scholar 

  57. Halpern CH, Tekriwal A, Santollo J, Keating JG, Wolf JA, Daniels D, et al. Amelioration of binge eating by nucleus accumbens shell deep brain stimulation in mice involves D2 receptor modulation. J Neurosci. 2013;33(17):7122–9.

    Article  CAS  Google Scholar 

  58. Mavridis I. The role of the nucleus accumbens in psychiatric disorders. Psychiatriki. 2015;25(4):282–94.

    CAS  Google Scholar 

  59. Qu L, Ge S, Li N, Wang W, Yang K, Wu P, et al. Clinical evaluation of deep brain stimulation of nucleus accumbens/anterior limb of internal capsule for opioid relapse prevention: Protocol of a multicentre, prospective and double-blinded study. BMJ Open. 2019;9(2):e023516.

    Google Scholar 

  60. Real E, Plans G, Alonso P, Aparicio MA, Segalàs C, Cardoner N, et al. Removing and reimplanting deep brain stimulation therapy devices in resistant OCD (when the patient does not respond): Case report. BMC Psychiatry. 2016;16(1).

    Google Scholar 

  61. Campbell CS, Clark LA, Loy D, Keenan JF, Matthews K, Winograd T, et al. The bodily incorporation of mechanical devices: Ethical and religious issues (part 2). Camb Q Healthc Ethics. 2007;16(3):268–80.

    Google Scholar 

  62. Campbell CS, Clark LA, Loy D, Keenan JF, Matthews K, Winograd T, et al. The bodily incorporation of mechanical devices: Ethical and religious issues (part 1). Camb Q Healthc Ethics. 2007;16(2):229–39.

    Google Scholar 

  63. Okun MS, Zeilman PR, Foundation NP. Parkinson’s disease: Deep brain stimulation a practical guide for patients and families. 2 ed; 2014. https://www.med.upenn.edu/pdmdc/assets/user-content/deep-brain-stimulation-guide-parkinsons.pdf.

  64. Ogden CL, Fakhouri TH, Carroll MD, Hales CM, Fryar CD, Li X, et al. Prevalence of obesity among adults, by household income and education: United States, 2011-2014. MMWR Morb Mortal Wkly Rep. 2017;66(50):1369–73.

    Article  Google Scholar 

  65. Carroll W, Rhoades J. Obesity in America: Estimates for the U.S. civilian noninstitutionalized population age 20 and older, 2009. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2012. https://www.meps.ahrq.gov/data_files/publications/st364/stat364.shtml.

  66. Berchick ER, Barnett JC, Upton RD. Health insurance coverage in the United States: 2018, report number P60–267 (RV). U.S. Department of Commerce. U.S. Census Bureau; 2019. https://www.census.gov/library/publications/2019/demo/p60-267.html.

  67. Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: A 5-year prospective study. Obes Surg. 2008;18(6):648–51.

    Google Scholar 

  68. Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of obesity and severe obesity among adults: United States, 2017–2018. Hyattsville, MD: National Center for Health Statistics (NCHS); 2020. https://www.cdc.gov/nchs/products/databriefs/db360.htm.

    Google Scholar 

  69. HHS. E6(R2) Good clinical practice: Integrated addendum to ICH E6(R1): Guidance for industry. Silver Spring, MD: U.S. Department of Health & Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 2018 [updated March 2018]. https://www.fda.gov/media/93884/download.

  70. WMA. WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects. Helsinki, Finland: World Medical Association (WMA); 1964 [updated October 2013 in Fortaleza, Brazil]. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.

  71. Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of obesity among adults and youth: United States, 2015–2016. NCHS data brief, no 288. Hyattsville, MD: National Center for Health Statistics (NCHS); 2017. https://www.cdc.gov/nchs/data/databriefs/db288.pdf.

  72. NIH. Vulnerable and other populations requiring additional protections. Bethesda, MD: National Institutes of Health; 2019 [updated January 7, 2019]. https://grants.nih.gov/policy/humansubjects/policies-and-regulations/vulnerable-populations.htm.

  73. Snyder AG. Psychological assessment of the patient undergoing bariatric surgery. Ochsner J. 2009;9(3):144–8.

    Google Scholar 

  74. Hubbard VS, Hall WH. Gastrointestinal surgery for severe obesity. Obes Surg. 1991;1(3):257–65.

    CAS  Google Scholar 

  75. Flores CA. Psychological assessment for bariatric surgery: Current practices. ABCD Arquivos Brasileiros de Cirurgia Digestiva (São Paulo). 2014;27(suppl 1):59–62.

    Google Scholar 

  76. Engstrom D. Why is it required to have a psychological evaluation prior to weight-loss surgery? Obesity Action Coalition (OAC); 2006. https://www.obesityaction.org/community/article-library/why-is-it-required-to-have-a-psychological-evaluation-prior-to-weight-loss-surgery/.

  77. Wyatt HR. Update on treatment strategies for obesity. J Clin Endocrinol Metab. 2013;98(4):1299–306.

    Google Scholar 

  78. Karmali S, Johnson Stoklossa C, Sharma A, Stadnyk J, Christiansen S, Cottreau D, et al. Bariatric surgery: A primer. Can Fam Physician. 2010;56(9):873–9.

    Google Scholar 

  79. Wolfe BM, Kvach E, Eckel RH. Treatment of obesity: Weight loss and bariatric surgery. Circ Res. 2016;118(11):1844–55.

    Google Scholar 

  80. HHS-OCR. Summary of the HIPAA privacy rule. Washington, D.C.: U.S. Department of Health & Human Services; 2013 [updated July 26, 2013]. https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html.

Further Reading

  • Halpern CH, Wolf JA, Bale TL, Stunkard AJ, Danish SF, Grossman M, et al. Deep brain stimulation in the treatment of obesity. J Neurosurg. 2008;109(4):625–34.

    Google Scholar 

  • Ho AL, Sussman ES, Pendharkar AV, Azagury DE, Bohon C, Halpern CH. Deep brain stimulation for obesity: Rationale and approach to trial design. Neurosurg Focus. 2015;38(6):E8.

    Google Scholar 

  • Khan FR, Henderson JM. Deep brain stimulation surgical techniques. Handb Clin Neurol. 2013;116:27–37.

    Article  Google Scholar 

  • Lennerz B, Lennerz JK. Food addiction, high-glycemic-index carbohydrates, and obesity. Clin Chem. 2018;64(1):64–71.

    Article  CAS  Google Scholar 

  • Wu H, Adler S, Azagury DE, Bohon C, Safer DL, Barbosa DAN, et al. Brain-responsive neurostimulation for loss of control eating: Early feasibility study. Neurosurgery. 2020;87(6):1277–88.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Casey H. Halpern .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2023 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Ojukwu, D.I., Barbosa, D.A.N., Caplan, A.L., Halpern, C.H. (2023). Neurosurgery and Neuroinnovation in the Surgical Suite: The Ethics of Neurostimulation for Severe Obesity. In: Roberts, L.W. (eds) Ethics and Clinical Neuroinnovation. Springer, Cham. https://doi.org/10.1007/978-3-031-14339-7_7

Download citation

Publish with us

Policies and ethics