Abstract
BackgroundAnorexia 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.DesignForty-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.DiscussionThe 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.Trial registrationISRCTN14329415. Date of registration: 23 July 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1069-3) contains supplementary material, which is available to authorized users.
Highlights
Anorexia nervosa (AN) is a serious mental disorder with multiple comorbidities and complications
Results from this study will provide a preliminary indication of the efficacy of repetitive transcranial magnetic stimulation (rTMS) treatment for AN, the neural correlates of the illness, and potential biomarkers of clinical response
Improvements in self-regulatory control abilities will be associated with changes in task-based neural activity and connectivity between the dorsolateral prefrontal cortex (DLPFC) and the inhibitory control network and areas implicated in reward processing; (3)alter neural activity in the DLPFC at rest and during task performance during functional magnetic resonance imaging, which will be correlated with symptom improvement; and (4)be considered by patients as an acceptable and useful treatment adjunct for AN
Summary
Treatment outcomes for psychotherapies are modest for adults with AN, and there is currently no gold-standard treatment [103]. Providing participants who were randomised to receive sham rTMS with the opportunity to receive real rTMS after they have completed the study is thought to be critical in encouraging recruitment and participant retention Addressing these challenges will be useful in informing the development of future large-scale RCT of rTMS in EDs. In summary, research into novel treatments for SEEDAN is essential. RTMS is a promising neuromodulatory technique that has shown preliminary benefit in AN, including individuals with SEED-AN This innovative feasibility RCT will be the first to systematically assess the acceptability, efficacy and neural correlates of this promising treatment in comparison to an active control condition. All authors contributed to the design and conception of the study, were involved in drafting, critiquing and approving of the manuscript, and accept responsibility for the accuracy and integrity of this work
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