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Jnnp-2013-306580.Full.Pdf JNNP Online First, published on January 20, 2014 as 10.1136/jnnp-2013-306580 Neurosurgery J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp-2013-306580 on 20 January 2014. Downloaded from RESEARCH PAPER Consensus on guidelines for stereotactic neurosurgery for psychiatric disorders Bart Nuttin,1,2,3,4 Hemmings Wu,1 Helen Mayberg,3,5 Marwan Hariz,4,6 Loes Gabriëls,4,7 Thorsten Galert,3,8 Reinhard Merkel,3,9 Cynthia Kubu,3,10 Osvaldo Vilela-Filho,4,11 Keith Matthews,4,12 Takaomi Taira,13 Andres M Lozano,14 Gastón Schechtmann,4,15 Paresh Doshi,4,16 Giovanni Broggi,4,17 Jean Régis,4,18 Ahmed Alkhani,4,19 Bomin Sun,4,20 Sam Eljamel,4,21 Michael Schulder,22 Michael Kaplitt,23 Emad Eskandar,24 Ali Rezai,25 Joachim K Krauss,26 Paulien Hilven,27 Rick Schuurman,28 Pedro Ruiz,29 Jin Woo Chang,4,30 Paul Cosyns,31 Nir Lipsman,4,32 Juergen Voges,4,33 Rees Cosgrove,4,34 Yongjie Li,35 Thomas Schlaepfer3,36 For numbered affiliations see ABSTRACT some cases, more technical interventions such as end of article. Background For patients with psychiatric illnesses electroconvulsive therapy. These evidence-based ‘ ’ Correspondence to remaining refractory to standard therapies, treatments may be used either alone or in combin- Dr Bart Nuttin, Department of neurosurgical procedures may be considered. Guidelines ation. However, a substantial minority of patients Neurosurgery, UZ Leuven, KU for safe and ethical conduct of such procedures have either does not respond, fails to sustain response or Leuven, Herestraat 49, 3000 previously and independently been proposed by various experiences unacceptable adverse effects. It is for Leuven Belgium; bart.nuttin@ local and regional expert groups. these patients, who are even more at risk with non- kuleuven.be Methods To expand on these earlier documents, treatment, that the use of neurosurgical procedures BN and HW contributed representative members of continental and international such as stereotactic focal ablative surgery or deep copyright. equally to this study. psychiatric and neurosurgical societies, joined efforts to brain stimulation (DBS) may be considered.12Case further elaborate and adopt a pragmatic worldwide set reports, case series and small-scale clinical trials of From the World Society for Stereotactic and Functional of guidelines. These are intended to address a broad neurosurgical interventions have been reported in Neurosurgery (WSSFN), the range of neuropsychiatric disorders, brain targets and patients with obsessive-compulsive disorder (OCD), Working Group ‘Deep Brain neurosurgical techniques, taking into account cultural major depressive disorder (MDD), substance abuse/ Stimulation in Psychiatry: and social heterogeneities of healthcare environments. addiction and anorexia nervosa, among others. Guidance for Responsible Findings The proposed consensus document highlights The published experience of DBS for these con- Research and Application’, the European Society for that, while stereotactic ablative procedures such as ditions would appear to have intuitive appeal since Stereotactic and Functional cingulotomy and capsulotomy for depression and DBS is both adjustable and in most cases reversible Neurosurgery (ESSFN), the obsessive-compulsive disorder are considered in contrast to stereotactic ablative techniques. DBS American Society for ‘ ’ established in some countries, they still lack level I nonetheless requires an invasive implantation of a http://jnnp.bmj.com/ Stereotactic and Functional Neurosurgery (ASSFN), the evidence. Further, it is noted that deep brain stimulation permanent device in the brain, with the inherent Latin American Society for in any brain target hitherto tried, and for any psychiatric risks of the surgical procedure and the burden of Stereotactic and Functional or behavioural disorder, still remains at an investigational managing, maintaining and replacing the device. Neurosurgery (SLANFE), the stage. Researchers are encouraged to design randomised Until scientifically proven otherwise, DBS is not Asian- Australasian Society for controlled trials, based on scientific and data-driven superior to ablative surgery for psychiatric disor- Stereotactic and Functional fi Neurosurgery (AASSFN) and rationales for disease and brain target selection. ders. Clinical studies in this eld may provide an the World Psychiatric Experienced multidisciplinary teams are a mandatory unprecedented opportunity for fundamental work on September 24, 2021 by guest. Protected Association (WPA) requirement for the safe and ethical conduct of any with regard to examining disease pathophysiology psychiatric neurosurgery, ensuring documented and the mechanisms of action of these therapies.3 Received 25 September 2013 Revised 30 November 2013 refractoriness of patients, proper consent procedures that Accepted 18 December 2013 respect patient’s capacity and autonomy, multifaceted preoperative as well as postoperative long-term follow- METHODS up evaluation, and reporting of effects and side effects The Committee for Neurosurgery for Psychiatric for all patients. Disorders, as part of the World Society for Interpretation This consensus document on ethical Stereotactic and Functional Neurosurgery (WSSFN) and scientific conduct of psychiatric surgery worldwide is and the European Society for Stereotactic and designed to enhance patient safety. Functional Neurosurgery (ESSFN), partnering with the Working Group ‘Deep Brain Stimulation in To cite: Nuttin B, Wu H, Psychiatry: Guidance for Responsible Research and Mayberg H, et al. J Neurol Application’, along with the Psychiatric Neurosurg Psychiatry Published Online First: BACKGROUND Neurosurgery Committee of the American Society [please include Day Month The majority of patients affected by psychiatric dis- for Stereotactic and Functional Neurosurgery Year] doi:10.1136/jnnp- orders can be managed effectively by means of (ASSFN), the Latin American Society for Stereotactic 2013-306580 pharmacological therapies, psychotherapy and in and Functional Neurosurgery (SLANFE), the NuttinCopyright B, et al. J Neurol Article Neurosurg author Psychiatry (or2014; their0:1– 6.employer) doi:10.1136/jnnp-2013-306580 2014. Produced by BMJ Publishing Group Ltd under licence. 1 Neurosurgery J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp-2013-306580 on 20 January 2014. Downloaded from Asian-Australasian Society for Stereotactic and Functional anterior cingulotomy for MDD and OCD in the USA, Scotland, Neurosurgery (AASSFN) and the World Psychiatric Association South Korea and elsewhere), the nature of these and many other (WPA), propose an expanded set of guidelines to articulate a con- procedures in neurosurgery, including DBS for psychiatric disor- sensus summary of clinical research standards that are applicable ders, remains at a ‘proof-of-principle’ investigational stage of to testing of DBS and ablative neurosurgery in addition to other development.4 emerging neurosurgical interventions for neuropsychiatric Current practised stereotactic ablative procedures do not have disorders. level I evidence with randomised controlled trials, but their The need for such consensus of guidelines was first identified safety and efficacy are supported by level II evidence in by the Committee for Neurosurgery for Psychiatric Disorders treatment-refractory MDD and OCD. However, this degree of (WSSFN) in early 2011. Then the first text was drafted and evidence is not yet available for ‘new’ lesioning methods such as revised by HW and BN, respectively, based on literature review. gamma knife and stereotactic-focused ultrasound. MH provided an important part of the references. This text was In this delicate field of neurosurgery for psychiatric disorders, presented by BN to the Working Group ‘Deep Brain it seems reasonable to state the following requirement before Stimulation in Psychiatry: Guidance for Responsible Research the surgical intervention can be stated as ‘approved therapy’.At and Application’ for further in-depth discussion, leading to a least two blinded (if possible) randomised controlled clinical very extensively modified version of the previous text. trials from two different groups of researchers need to be pub- Afterwards, it was distributed internally by BN among represen- lished, both showing an acceptable risk–benefit ratio, at least tatives of different international societies (WSSFN, ESSFN, comparable with other existing therapies. ASSFN, SLANFE, AASSFN and WPA), from whom remarks Furthermore, there is a resurgence of ablative procedures in were received, leading to an optimised consensus text, which resource-poor contexts, where access to medication, psychother- was finally approved and endorsed by the representatives of the apy and more expensive neurosurgical interventions like DBS is different societies in late 2011/early 2012. limited. Ablative surgery also becomes an alternative in cases The guidelines for neurosurgery for psychiatric disorders pre- where a DBS procedure has failed to control the patient’s symp- sented in this document recognise the Declaration of Helsinki, toms or where DBS or other neuromodulatory strategies are issued by the World Medical Association in 1964, amended inappropriate or impractical. several times, as the fundamental document in the field of ethics We encourage researchers to design independent, randomised in biomedical research. and blinded (where possible) controlled trials, with the least The following guidelines are built directly upon the core ele- possible conflict of interest and bias, to strive
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