Abstract
The applications of deep brain stimulation (DBS) are rapidly increasing and now include a large variety of neurological and psychiatric diseases, such as addiction, Alzheimer’s disease, anorexia nervosa, and rare movement disorders. High-quality data about benefit and harm of DBS in these disorders remain rare as many findings rely on small cohorts or single cases, variable methodologies, and differing outcome measures. Collectively, these problems make the field prone to bias and selective reporting, evoke ethical concerns regarding possibly premature expansions to new conditions without appropriate justification and research, and indicate the possibility that media, the public, and institutional review boards might be easily misguided by some reports. Thus, these problems are primarily not of scientific or methodological nature, but of ethical nature. Here, three approaches are suggested on how these problems might be reduced: by an optimization of trial designs, the implementation of standards of reporting, and the creation of a DBS study register which includes in particular single-case studies or case series. Future work has to work out these proposals in more detail and study its effectiveness when implemented in practice.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Agid, Y., Schupbach, M., Gargiulo, M., Mallet, L., Houeto, J. L., Behar, C., & Welter, M. L. (2006). Neurosurgery in Parkinson’s disease: The doctor is happy, the patient less so? Journal of Neural Transmission. Supplementum, 70, 409–414.
Bell, E., Mathieu, G., & Racine, E. (2009). Preparing the ethical future of deep brain stimulation. Surgical Neurology, 72(6), 577–586.
Bewernick, B. H., Hurlemann, R., Matusch, A., Kayser, S., Grubert, C., Hadrysiewicz, B., & Schlaepfer, T. E. (2010). Nucleus accumbens deep brain stimulation decreases ratings of depression and anxiety in treatment-resistant depression. Biological Psychiatry, 67(2), 110–116.
Castelnau, P., Cif, L., Valente, E. M., Vayssiere, N., Hemm, S., Gannau, A., . . . Coubes, P. (2005). Pallidal stimulation improves pantothenate kinase-associated neurodegeneration. Annals of Neurology, 57(5), 738–741. doi:10.1002/ana.20457.
Clausen, J. (2009). Man, machine and in between. Nature, 457(7233), 1080–1081.
Clausen, J. (2010). Ethical brain stimulation – neuroethics of deep brain stimulation in research and clinical practice. The European Journal of Neuroscience, 32, 1152–1162.
Cornu, C., Kassai, B., Fisch, R., Chiron, C., Alberti, C., Guerrini, R., & Nabbout, R. (2013). Experimental designs for small randomised clinical trials: An algorithm for choice. Orphanet Journal of Rare Diseases, 8, 48. doi:10.1186/1750-1172-8-48.
Coultas, D. (2007). Ethical considerations in the interpretation and communication of clinical trial results. Proceedings of the American Thoracic Society, 4(2), 194–198; discussion 198–199.
de Zwaan, M., & Schlaepfer, T. E. (2013). Not too much reason for excitement: Deep Brain Stimulation for Anorexia Nervosa. European Eating Disorders Review. doi:10.1002/erv.2258.
DeAngelis, C. D., Drazen, J. M., Frizelle, F. A., Haug, C., Hoey, J., Horton, R., & Van Der Weyden, M. B. (2004). Clinical trial registration: A statement from the International Committee of Medical Journal Editors. JAMA: The Journal of the American Medical Association, 292(11), 1363–1364.
DeAngelis, C. D., Drazen, J. M., Frizelle, F. A., Haug, C., Hoey, J., Horton, R., & Van Der Weyden, M. B. (2005). Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. JAMA: The Journal of the American Medical Association, 293(23), 2927–2929.
Dickersin, K., & Rennie, D. (2003). Registering clinical trials. JAMA: The Journal of the American Medical Association, 290(4), 516–523.
Dunner, D. L., Rush, A. J., Russell, J. M., Burke, M., Woodard, S., Wingard, P., & Allen, J. (2006). Prospective, long-term, multicenter study of the naturalistic outcomes of patients with treatment-resistant depression. The Journal of Clinical Psychiatry, 67(5), 688–695.
Fins, J. J. (2000). A proposed ethical framework for interventional cognitive neuroscience: A consideration of deep brain stimulation in impaired consciousness. Neurological Research, 22(3), 273–278.
Franzini, A., Marras, C., Ferroli, P., Bugiani, O., & Broggi, G. (2005). Stimulation of the posterior hypothalamus for medically intractable impulsive and violent behavior. Stereotactic and Functional Neurosurgery, 83(2–3), 63–66.
Hamani, C., McAndrews, M. P., Cohn, M., Oh, M., Zumsteg, D., Shapiro, C. M., & Lozano, A. M. (2008). Memory enhancement induced by hypothalamic/fornix deep brain stimulation. Annals of Neurology, 63(1), 119–123.
Hariz, M., Blomstedt, P., & Zrinzo, L. (2013). Future of brain stimulation: New targets, new indications, new technology. Movement Disorders. doi:10.1002/mds.25665.
Hutton, P. (2013). Deep brain stimulation for anorexia nervosa. Lancet, 328, 305–306.
Kuhn, J., Lenartz, D., Huff, W., Lee, S., Koulousakis, A., Klosterkoetter, J., & Sturm, V. (2007). Remission of alcohol dependency following deep brain stimulation of the nucleus accumbens: Valuable therapeutic implications? Journal of Neurology, Neurosurgery, and Psychiatry, 78(10), 1152–1153.
Kuhn, J., Bauer, R., Pohl, S., Lenartz, D., Huff, W., Kim, E. H., & Sturm, V. (2009). Observations on unaided smoking cessation after deep brain stimulation of the nucleus accumbens. European Addiction Research, 15(4), 196–201.
Kupsch, A., Benecke, R., Muller, J., Trottenberg, T., Schneider, G. H., Poewe, W., . . . Volkmann, J. (2006). Pallidal deep-brain stimulation in primary generalized or segmental dystonia. The New England Journal of Medicine, 355(19), 1978–1990.
Laxton, A. W., Tang-Wai, D. F., McAndrews, M. P., Zumsteg, D., Wennberg, R., Keren, R., . . . Lozano, A. M. (2010). A phase I trial of deep brain stimulation of memory circuits in Alzheimer’s disease. Annals of Neurology, 68(4), 521–534.
Li, P., Huang, R., Song, W., Ji, J., Burgunder, J. M., Wang, X., . . . Shang, H. F. (2012). Deep brain stimulation of the globus pallidus internal improves symptoms of chorea-acanthocytosis. Neurological Sciences, 33(2), 269–274. doi:10.1007/s10072-011-0741-y.
Lipsman, N., Woodside, D. B., Giacobbe, P., Hamani, C., Carter, J. C., Norwood, S. J., . . . Lozano, A. M. (2013). Subcallosal cingulate deep brain stimulation for treatment-refractory anorexia nervosa: A phase 1 pilot trial. Lancet, 381(9875), 1361–1370. doi:10.1016/S0140-6736(12)62188-6.
Mallet, L., Polosan, M., Jaafari, N., Baup, N., Welter, M. L., Fontaine, D., . . . Pelissolo, A. (2008). Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. The New England Journal of Medicine, 359(20), 2121–2134.
Mammis, A., Pourfar, M., Feigin, A., & Mogilner, A. Y. (2012). Deep brain stimulation for the treatment of tremor and ataxia associated with abetalipoproteinemia. Tremor and Other Hyperkinetic Movements (New York, N.Y.), 2.
Mayberg, H. S., Lozano, A. M., Voon, V., McNeely, H. E., Seminowicz, D., Hamani, C., & Kennedy, S. H. (2005). Deep brain stimulation for treatment-resistant depression. Neuron, 45(5), 651–660.
Moher, D., Schulz, K. F., & Altman, D. (2001). The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA: The Journal of the American Medical Association, 285(15), 1987–1991.
Muller, U. J., Voges, J., Steiner, J., Galazky, I., Heinze, H. J., Moller, M., & Kuhn, J. (2013). Deep brain stimulation of the nucleus accumbens for the treatment of addiction. Annals of the New York Academy of Sciences, 1282, 119–128. doi:10.1111/j.1749-6632.2012.06834.x.
Okun, M. S., Mann, G., Foote, K. D., Shapira, N. A., Bowers, D., Springer, U., . . . Goodman, W. K. (2007). Deep brain stimulation in the internal capsule and nucleus accumbens region: Responses observed during active and sham programming. Journal of Neurology, Neurosurgery, and Psychiatry, 78(3), 310–314.
Schiff, N. D., Giacino, J. T., Kalmar, K., Victor, J. D., Baker, K., Gerber, M., . . . Rezai, A. R. (2007). Behavioural improvements with thalamic stimulation after severe traumatic brain injury. Nature, 448(7153), 600–603.
Schlaepfer, T. E., & Fins, J. J. (2010). Deep brain stimulation and the neuroethics of responsible publishing: When one is not enough. JAMA: The Journal of the American Medical Association, 303(8), 775–776.
Schlaepfer, T. E., Cohen, M. X., Frick, C., Kosel, M., Brodesser, D., Axmacher, N., . . . Sturm, V. (2008). Deep brain stimulation to reward circuitry alleviates anhedonia in refractory major depression. Neuropsychopharmacology, 33(2), 368–377.
Schupbach, M., Gargiulo, M., Welter, M. L., Mallet, L., Behar, C., Houeto, J. L., . . . Agid, Y. (2006). Neurosurgery in Parkinson disease: A distressed mind in a repaired body? Neurology, 66(12), 1811–1816.
Synofzik, M., & Schlaepfer, T. E. (2008). Stimulating personality: Ethical criteria for deep brain stimulation in psychiatric patients and for enhancement purposes. Biotechnology Journal, 3(12), 1511–1520.
Synofzik, M., & Schlaepfer, T. E. (2010). Neuromodulation – ECT, rTMS, DBS. In H. Helmchen & N. Sartorius (Eds.), Ethics in psychiatry. European contributions (pp. 299–320). Heidelberg: Springer.
Synofzik, M., & Schlaepfer, T. E. (2011). Electrodes in the brain-ethical criteria for research and treatment with deep brain stimulation for neuropsychiatric disorders. Brain Stimulation, 4(1), 7–16.
Synofzik, M., Fins, J. J., & Schlaepfer, T. E. (2012). A neuromodulation experience registry for deep brain stimulation studies in psychiatric research: Rationale and recommendations for implementation. Brain Stimulation, 5(4), 653–655. doi:10.1016/j.brs.2011.10.003.
Warnke, P. (2013). Deep brain stimulation for movement disorders: What counts in the end is the end result. Journal of Neurology, Neurosurgery, and Psychiatry. doi:10.1136/jnnp-2013-305832.
Wu, H., Van Dyck-Lippens, P. J., Santegoeds, R., van Kuyck, K., Gabriels, L., Lin, G., . . . Nuttin, B. (2013). Deep-brain stimulation for anorexia nervosa. World Neurosurgery, 80(3–4), S29 e21-S29 e10. doi:10.1016/j.wneu.2012.06.039.
Zarin, D. A., & Tse, T. (2008). Medicine. Moving toward transparency of clinical trials. Science, 319(5868), 1340–1342.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer Science+Business Media Dordrecht
About this entry
Cite this entry
Synofzik, M. (2015). Deep Brain Stimulation Research Ethics: The Ethical Need for Standardized Reporting, Adequate Trial Designs, and Study Registrations. In: Clausen, J., Levy, N. (eds) Handbook of Neuroethics. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-4707-4_32
Download citation
DOI: https://doi.org/10.1007/978-94-007-4707-4_32
Published:
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-007-4706-7
Online ISBN: 978-94-007-4707-4
eBook Packages: Humanities, Social Sciences and Law