Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial.
Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial.
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DOI：
10.1186/s13063-015-1069-3
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发表时间：
2015-12-03
期刊：
影响因子：
2.5
通讯作者：
Schmidt U
中科院分区：
文献类型：
--
作者：
Bartholdy S;McClelland J;Kekic M;O'Daly OG;Campbell IC;Werthmann J;Rennalls SJ;Rubia K;David AS;Glennon D;Kern N;Schmidt U
神经性厌食症（AN）是一种严重的精神障碍，具有多种合并症和并发症。在患有严重和持久形式的疾病（SEED-AN）的患者中，治疗反应较差，证据基础有限。因此，需要新的治疗策略。本文介绍了一项可行性随机对照试验（RCT）的理论背景和方案，该试验是在SEED-AN中进行的真实与虚假（安慰剂）治疗性重复经颅磁刺激（rTMS）。本试验的目的是获得指导决策和方案制定的信息，以指导未来在这组患者中进行rTMS的大规模随机对照试验，并评估rTMS治疗的初步疗效和神经相关性。在平行组设计中，来自社区的44名患有DSM-5诊断为AN的成年人，病程100 - 3年，之前的治疗过程不成功，将被随机分配接受20次真实或虚假的rTMS。由于这是一项可行性研究，尚未确定主要结果，将审查广泛的结果变量。这些包括体重/身体质量指数（BMI）、饮食失调精神病理学、其他精神病理学（例如抑郁、焦虑）、生活质量、神经心理学过程（例如自我调节、注意力偏差和食物选择行为）、神经成像测量（即大脑结构或功能的变化）、rTMS的耐受性和可接受性，以及额外的服务利用。开展rTMS大规模随机对照试验的可行性以及rTMS作为SEED-AN治疗方法的适宜性将通过以下方式进行评估：招募和保留率评估、随机分配的可接受性、盲法成功（分配隐藏）、治疗期完成情况和研究评估（基线、治疗后和随访评估）。治疗的可接受性和耐受性将通过半结构化访谈进行评估。该试验产生的效应大小和其他发现将为未来的大规模随机对照试验提供信息，以决定主要结局指标和方案制定的其他方面。此外，本研究的结果将为rTMS治疗AN的疗效、该疾病的神经相关因素和临床反应的潜在生物标志物提供初步指示。ISRCTN14329415。注册日期：2015年7月23日。本文的在线版本（doi:10.1186/s13063-015-1069-3）包含补充材料，可供授权用户使用。
Anorexia nervosa (AN) is a serious mental disorder with multiple comorbidities and complications. In those with a severe and enduring form of the illness (SEED-AN), treatment responsivity is poor and the evidence base limited. Thus, there is a need for novel treatment strategies. This paper describes the theoretical background and protocol of a feasibility randomised controlled trial (RCT) of real versus sham (placebo) therapeutic repetitive transcranial magnetic stimulation (rTMS) in SEED-AN. The aim of this trial is to obtain information that will guide decision making and protocol development in relation to a future large-scale RCT of rTMS in this group of patients, and also to assess the preliminary efficacy and neural correlates of rTMS treatment. Forty-four adults from the community with a DSM-5 diagnosis of AN, an illness duration >3 years and a previous course of unsuccessful treatment will be randomly allocated to receive 20 sessions of either real or sham rTMS, in a parallel group design. As this is a feasibility study, no primary outcome has been defined and a broad range of outcome variables will be examined. These include weight/body mass index (BMI), eating disorder psychopathology, other psychopathology (for example, depression, anxiety), quality of life, neuropsychological processes (such as self-regulation, attentional bias and food choice behaviour), neuroimaging measures (that is, changes in brain structure or function), tolerability and acceptability of rTMS, and additional service utilisation. The feasibility of conducting a large-scale RCT of rTMS and the appropriateness of rTMS as a treatment for SEED-AN will be evaluated through: assessment of recruitment and retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments (baseline, post-treatment and follow-up assessments). The acceptability and tolerability of the treatment will be assessed via semi-structured interviews. The effect sizes generated and other findings from this trial will inform a future large-scale RCT with respect to decisions on primary outcome measures and other aspects of protocol development. Additionally, results from this study will provide a preliminary indication of the efficacy of rTMS treatment for AN, the neural correlates of the illness, and potential biomarkers of clinical response. ISRCTN14329415. Date of registration: 23 July 2015. The online version of this article (doi:10.1186/s13063-015-1069-3) contains supplementary material, which is available to authorized users.