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• Comments on the recent paper by Lipsman et al., "Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design"
  Tobias Skuban-Eiseler
  Published on: 3 October 2012

• Published on: 3 October 2012

  Comments on the recent paper by Lipsman et al., "Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design"

  • Tobias Skuban-Eiseler, Dr
  • Other Contributors:
    • Prof Kuhn, J

  In their recent paper "Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design",[1] Lipsman et al. discuss important factors that influence informed consent for deep brain stimulation when applied in clinical trials concerning psychiatric diseases. Undoubtedly the issue of informed consent to DBS and its ethical implications hardly can be overest...

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  In their recent paper "Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design",[1] Lipsman et al. discuss important factors that influence informed consent for deep brain stimulation when applied in clinical trials concerning psychiatric diseases. Undoubtedly the issue of informed consent to DBS and its ethical implications hardly can be overestimated, especially in the context of the ambivalent history of deep brain stimulation and psychosurgery.[2] Nevertheless, we would like to take the opportunity and make some comments on the valuable insights unfolded in the paper mentioned.

  It is utterly correct that researchers/therapists must communicate to the patient the experimental character of the procedure (when applied for the treatment of psychiatric diseases); this experimental character arises from, as the authors lined out, its unclear mechanism of action and its to some extent unpredictable outcome. In this context it should also be mentioned that to date there are no studies concerning the impact of a patient's former therapies on the efficacy of DBS. Moreover, although usually regarded as "last resort therapy" when all available other options have failed, there does not exist any scientific rationale why patients might not benefit from DBS if it was applied in an earlier time point of disease progress. A reason to consider DBS as a potentially advantageous therapeutic instrument in earlier stages of a psychiatric disease could possibly be deduced from clinical and pathophysiological experiences from the treatment of Parkinson's disease by DBS. In this context a possible neuroprotective effect which might arise from the stimulation of the subthalamic nucleus should be mentioned.[3, 4, 5] This could serve as a rationale for an application of DBS in early Parkinson stages (compare also the ongoing study "Controlled Trial of Deep Brain Stimulation in Early Patients With Parkinson's Disease", http://clinicaltrials.gov/ct2/show/NCT00354133 ). Maybe, there are similar pathophysiologic mechanisms at work when DBS is used for the therapy of psychiatric diseases. Moreover, in the case of OCD there are hints that the efficacy of cognitive behavioral therapy might be improved by DBS.[6] This could serve as an argument for an application of DBS in early stages of OCD. However, concerning DBS for the treatment of early stages of psychiatric diseases in general would pose even more delicate ethical questions regarding the obtainment of informed consent. A second comment refers to the authors' strong advice to apply DBS (at least with respect to the currently available scientific knowledge) primarily in psychiatric diseases that are ego-dystonic in character, such as OCD or major depression. However, about 5 to 45% of OCD patients have been found to have poor insight into their obsessions and compulsions meaning that they consider their fears to be realistic and their obsessive behaviour actually capable of preventing disastrous consequences.[7-13] In 1994 the OCD subtype ?with poor insight" was included in DSM-IV ,[14] whereas this differentiation is not made in ICD-10. In these cases, the character of a patient's OCD cannot be classified as ego-dystonic in the stricter sense of the word. Moreover, there is a considerable amount of data hinting to an inversely proportional relationship of OCD severity and the level of a patient's insight,[7, 10, 15, 16] which also is in accordance with our own clinical experience. Taken together and following the line of argumentation presented in the authors' paper this would mean, that these patients - at least not first and foremost - should not be treated by DBS. However, OCD with poor insight might pose the greater proportion of therapy-resistant cases. Hence, we suggest OCD with poor insight to be considered as a general exception from the authors' advice regarding the ego-syn- or -dystonic character of psychiatric diseases treated with DBS. However, there is an urgent need for extended and thorough diagnostic efforts to differentiate patients suffering from OCD with poor insight from those with comorbid psychotic illnesses due to the fact (as it is also noted in the paper) that there is no sufficient rationale yet that these patients might benefit from DBS.

  1 Lipsman N, Giacobbe P, Bernstein M, et al. Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design. J Med Ethics 2012;38:107-11. 2 Skuban T, Hardenacke K, Woopen C, et al. Informed consent in deep brain stimulation - ethical considerations in a stress field of pride and prejudice. Front Integr Neurosci 2011;5:7

  3 Benazzouz A, Piallat B, Ni ZG, et al. Implication of the subthalamic nucleus in the pathophysiology and pathogenesis of Parkinson's disease. Cell Transplant 2000;9:215-21

  4 Piallat B, Benazzouz A, Benabid AL. Subthalamic nucleus lesion in rats prevents dopaminergic nigral neuron degeneration after striatal 6- OHDA injection: behavioural and immunohistochemical studies. Eur J Neurosci 1996;8:1408-14

  5 Nakao N, Nakai E, Nakai K, et al. Ablation of the subthalamic nucleus supports the survival of nigral dopaminergic neurons after nigrostriatal lesions induced by the mitochondrial toxin 3-nitropropionic acid. Ann Neurol 1999;45:640-51

  6 Denys D, Mantione M, Figee M, et al. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch Gen Psychiatry 2010;67:1061-8

  7 Catapano F, Perris F, Fabrazzo M, et al. Obsessive-compulsive disorder with poor insight: a three-year prospective study. Prog Neuropsychopharmacol Biol Psychiatry 2010;34:323-30

  8 Eisen JL, Rasmussen SA, Phillips KA, et al. Insight and treatment outcome in obsessive-compulsive disorder. Compr Psychiatry 2001;42:494-7

  9 Foa EB, Kozak MJ, Goodman WK, et al. DSM-IV field trial: obsessive- compulsive disorder. Am J Psychiatry 1995;152:90-6

  10 Ravi Kishore V, Samar R, Janardhan Reddy YC, et al. Clinical characteristics and treatment response in poor and good insight obsessive- compulsive disorder. Eur Psychiatry 2004;19:202-8

  11 Marazziti D, Dell'Osso L, Di Nasso E, et al. Insight in obsessive- compulsive disorder: a study of an Italian sample. Eur Psychiatry 2002;17:407-10

  12 Matsunaga H, Kiriike N, Matsui T, et al. Obsessive-compulsive disorder with poor insight. Compr Psychiatry 2002;43:150-7

  13 Storch EA, Milsom VA, Merlo LJ, et al. Insight in pediatric obsessive-compulsive disorder: associations with clinical presentation. Psychiatry Res 2008;160:212-20

  14 Jakubovski E, Pittenger C, Torres AR, et al. Dimensional correlates of poor insight in obsessive-compulsive disorder. Prog Neuropsychopharmacol Biol Psychiatry 2011;35:1677-81

  15 Solyom L, DiNicola VF, Phil M, et al. Is there an obsessive psychosis? Aetiological and prognostic factors of an atypical form of obsessive-compulsive neurosis. Can J Psychiatry 1985;30:372-80

  16 Turksoy N, Tukel R, Ozdemir O, et al. Comparison of clinical characteristics in good and poor insight obsessive-compulsive disorder. J Anxiety Disord 2002;16:413-23

  Conflict of Interest:

  None declared

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  Conflict of Interest:
  None declared.

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