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• W2321565121 abstract "To the Editor: It was with great interest that we read the recent article by Servello et al1 reporting the utility of deep brain stimulation (DBS) for treatment-refractory Tourette syndrome (TS) among 48 patients. Treatment-refractory TS is a significant concern for health providers, given the potentially physically harmful and impairing nature of some TS symptoms and the modest efficacy of existing treatments,2-6 resulting in a significant number of individuals requiring augmentative approaches. There is a clear need to develop and evaluate novel treatments for this population, and the authors present promising initial data. DBS has shown efficacy for several movement disorders (eg, Parkinson disease),7-12 although research with neuropsychiatric conditions is still in its infancy and with mixed findings.13,14 We wish to raise several conceptual points in relation to this article to clarify results and to highlight some suggestions for future research. The authors report positive results from one of the largest studies of DBS in TS to date. On balance, it is relevant to note that 23% of patients (n = 11) required removal of the device as a result of notable complications and infection (n = 8 [17%]) or poor compliance (n = 3 [6%]). Surgical revision was required in 12 patients (25%) who experienced skin erosions. Although occurring in a minority, tic symptoms worsened after DBS for 2 participants who retained the device (4% of all participants and 5% of completers). Symptoms did not change for another patient and decreased 4% for another. Despite the high rate of complications requiring discontinuation of treatment, completer analyses are reported instead of intent-to-treat analyses (consistent with many other studies in the DBS literature), which can result in misleading conclusions, particularly in the context of an experimental treatment being assessed in an uncontrolled and nonrandomized study. When those who discontinued the treatment are factored in, just over half (60%) experienced at least a 50% reduction in symptoms. Although promising, enthusiasm should be somewhat tempered, given that there was evidence of adverse effects of DBS in up to 29% of patients. The identification of suitable candidates for DBS for TS requires careful consideration. A lower age limit for DBS trials of 18 years has been suggested by an expert group of TS and DBS experts convened by the Tourette Syndrome Association,15 reduced from 25 years in previous recommendations,16 on the basis that the risk of surgical complications and adverse events did not appear to be greater among reported cases in patients <25 years of age who had documented DBS. Servello et al1 included patients 17 to 57 years of age and posed the question of whether DBS should be considered a last-line or bridging treatment for children and adolescents until remission, despite there being only 10 documented cases of DBS in patients <18 years of age.15 Findings in a previous case series (n = 18) suggested that 3 of 4 patients who had DBS implantation before 20 years of age had poor response after 3 to 6 months, including the need for frequent reprogramming.17 Although DBS has generally been well tolerated and effective in youth with dystonia, device removal resulting from infection occurred in 57% of children <10 years of age,18 casting concern about the use of DBS for childhood TS in light of the limited number of cases reported. Given the lack of firmly established efficacy for TS in adults, the rates of documented adverse effects, and the common pattern of symptom remission or reduction during adolescence and young adulthood,19-21 we have concerns about prematurely advocating the use of DBS in young populations. The authors rightly note that severe, unremitting tic symptoms during childhood and adolescence may have a negative impact on normal social development and psychological functioning.22-25 However, it is also important to consider the potential negative impact on psychosocial functioning of multiple invasive surgeries on a child (potentially) with limited improvement, adverse effects, or complications. Given the very early stage of evidence for DBS in TS, we would strongly caution against the use of this treatment among young patients until further data are collected, except perhaps in the context of cases in which the tic itself (eg, whiplash tics) carry a greater risk of harm than DBS.15 If DBS is used in young patients, it is critically important for these results to be published to inform the literature on tolerability and preliminary efficacy. The high rate of untreated severe comorbid psychiatric diagnoses is another important issue to consider for accurate evaluation of DBS candidates. Of the sample, 85% had a moderate to severe comorbid obsessive-compulsive disorder or depressive disorder diagnosis.1 As the authors noted, these conditions can be more impairing that the tic itself. Unfortunately, no information was provided on whether these conditions had also been refractory to evidence-based treatments conducted by an experienced therapist. These comorbidities can greatly influence both the symptom course of tics and the treatment compliance of patients after DBS surgery. As noted by Mink et al,16 attempts need to be made to adequately treat comorbid psychiatric conditions to fully eliminate the potential for tics to be symptomatic of greater disease burden. For patients to be considered for DBS surgery, we would suggest the need for individuals to have trialed therapeutic doses of evidence-based treatments for their TS and for comorbid psychiatric conditions to strengthen the potential for treatment effects to be seen. It is clear that for some patients with refractory TS, DBS may be a promising treatment option that warrants further evaluation. Servello et al1 suggest that DBS “hold[s] a promising future for movement and for behavioral disorders.” However, there is a clear need for further methodologically rigorous studies before any conclusions can be reached. We offer a number of important considerations for future research in this area: First, given encouraging results evident for some patients from case series and several small, double-blind, crossover, and/or controlled trials,26-29 there is a need for larger randomized, double-blind, sham-controlled trials with a priori target selection to systematically assess the efficacy of DBS treatment. Intent-to-treat analyses should be reported to adequately report on efficacy, tolerability, risks, and adverse events. Second, until efficacy is firmly established, larger trials should include only adult patients to ensure that treatment effects can be attributed to DBS rather than maturation. For child and adolescent patients in which all other treatment options have been exhausted, symptoms remain significantly impairing and/or dangerous, and risks have been adequately explained (to the patient and family), we suggest that DBS tolerability and response need to be documented in case reports. Third, an adequate dose of evidence-based treatment for comorbidities needs to be considered before invasive surgical procedures are entertained. This is likely to strengthen the power of DBS trials to be able to detect an effect on tics while reducing the negative impact of comorbidities on postsurgical care and compliance. Fourth, greater specificity for and guidance about DBS target selection and number of electrodes are needed for testing. Case and cohort studies can provide much-needed guidance about this selection; however, a standardized approach to target selection based on symptom phenotypes is needed to methodically assess efficacy and to provide accurate, evidence-based, generalizable results. Without this type of standardization, it is difficult to identify which patients are most likely to benefit from DBS, which sites should be targeted, and the utility of bilateral vs unilateral stimulation of a single target or simultaneous stimulation of multiple targets.30 Fifth, a standardized definition of what constitutes a refractory patient is also needed, at least within randomized trials, and it is critical that patients have failed to respond to habit reversal therapy and a therapeutic dose of pharmacotherapy. Finally, information is needed about the stability of symptom improvement after successful DBS treatment, maintenance, and treatment cessation. The Servello et al1 study represents an important advancement in the DBS literature for refractory TS, reporting one of the largest case series to date. This study also highlights a number of areas that warrant extension in future studies, including the role of comorbidity on efficacy and DBS in youth. There is a clear need to evaluate novel and innovative treatment options for this severe group of TS patients. Although routine reporting of data on TS patients treated with DBS is relevant to aid clinical decision making and to inform future research, methodologically rigorous studies with accurate and conservative reporting of results are also important considerations, especially given the potential for these results to be adopted into clinical practice with vulnerable, desperate, and highly distressed patients. Disclosures Dr Storch has received grant funding from the National Institutes of Health, All Children's Hospital Research Foundation, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, the National Alliance for Research on Schizophrenia and Affective Disorders, the International Obsessive Compulsive Disorder Foundation, the Tourette Syndrome Association, Janssen, and the Foundation for Research on Prader-Willi Syndrome. He receives honoraria from Springer, the American Psychological Association, Wiley, and Lawrence Erlbaum. He has served as an educational consultant for Rogers Memorial Hospital, Prophase, and CroNos. He has served on the speakers' bureau and scientific advisory board for the International Obsessive-Compulsive Disorder Foundation. He has received research support from the All Children's Hospital Guild Endowed Chair. The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article." @default.
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