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

Trials. 2015 Dec 3;16:548. doi: 10.1186/s13063-015-1069-3.

Abstract

Background: 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.

Design: 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.

Discussion: 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.

Trial registration: ISRCTN14329415 . Date of registration: 23 July 2015.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anorexia Nervosa / diagnosis
  • Anorexia Nervosa / physiopathology
  • Anorexia Nervosa / psychology
  • Anorexia Nervosa / therapy*
  • Body Mass Index
  • Brain / physiopathology*
  • Clinical Protocols
  • Double-Blind Method
  • Feasibility Studies
  • Feeding Behavior*
  • Female
  • Humans
  • Interviews as Topic
  • London
  • Male
  • Neuroimaging / methods
  • Patient Satisfaction
  • Psychiatric Status Rating Scales
  • Quality of Life
  • Research Design
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Time Factors
  • Transcranial Direct Current Stimulation* / adverse effects
  • Treatment Outcome

Associated data

  • ISRCTN/ISRCTN14329415