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  • Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study

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Mental health
Research
Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study
  1. Bethan Dalton1,
  2. Savani Bartholdy1,
  3. Jessica McClelland1,
  4. Maria Kekic1,
  5. Samantha J Rennalls2,
  6. Jessica Werthmann1,
  7. Ben Carter3,
  8. Owen G O’Daly2,
  9. Iain C Campbell1,
  10. Anthony S David4,
  11. Danielle Glennon5,
  12. Nikola Kern5,
  13. Ulrike Schmidt1,5
  1. 1 Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK
  2. 2 Department of Neuroimaging, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK
  3. 3 Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK
  4. 4 Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK
  5. 5 Eating Disorders Service, South London and Maudsley NHS Foundation Trust, London, UK
  1. Correspondence to Professor Ulrike Schmidt; ulrike.schmidt{at}kcl.ac.uk

Abstract

Objective Treatment options for severe, enduring anorexia nervosa (SE-AN) are limited. Non-invasive neuromodulation is a promising emerging intervention. Our study is a feasibility randomised controlled trial of repetitive transcranial magnetic stimulation (rTMS) in individuals with SE-AN, which aims to inform the design of a future large-scale trial.

Design Double-blind, parallel group, two-arm, sham-controlled trial.

Setting Specialist eating disorders centre.

Participants Community-dwelling people with anorexia nervosa, an illness duration of ≥3 years and at least one previous completed treatment.

Interventions Participants received 20 sessions (administered over 4 weeks) of MRI-guided real or sham high-frequency rTMS to the left dorsolateral prefrontal cortex in addition to treatment-as-usual.

Outcomes Primary outcomes were recruitment, attendance and retention rates. Secondary outcomes included body mass index (BMI), eating disorder symptoms, mood, quality of life and rTMS safety and tolerability. Assessments were conducted at baseline, post-treatment and follow-up (ie, at 0 month, 1 month and 4 months post-randomisation).

Results Thirty-four participants (17 per group) were randomly allocated to real or sham rTMS. One participant per group was withdrawn prior to the intervention due to safety concerns. Two participants (both receiving sham) did not complete the treatment. rTMS was safe and well tolerated. Between-group effect sizes of change scores (baseline to follow-up) were small for BMI (d=0.2, 95% CI −0.49 to 0.90) and eating disorder symptoms (d=0.1, 95% CI −0.60 to 0.79), medium for quality of life and moderate to large (d=0.61 to 1.0) for mood outcomes, all favouring rTMS over sham.

Conclusions The treatment protocol is feasible and acceptable to participants. Outcomes provide preliminary evidence for the therapeutic potential of rTMS in SE-AN. Largest effects were observed on variables assessing mood. This study supports the need for a larger confirmatory trial to evaluate the effectiveness of multi-session rTMS in SE-AN. Future studies should include a longer follow-up period and an assessment of cost-effectiveness.

Trial registration number ISRCTN14329415; Pre-results.

  • eating disorders
  • neuromodulation
  • anorexia nervosa
  • repetitive transcranial magnetic stimulation (rTMS)

This is an open access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2018-021531

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    Footnotes

    • BD, SB and JM contributed equally.

    • Contributors BD, SB, JM and US drafted the manuscript. BD and SB conducted data analysis, which was supervised by BC and US. OGO’D, ICC, MK, SJR, NK, DG and ASD revised the manuscript critically for important intellectual content. Ethical approval was obtained by SB, JM, MK and US. Funding from National Institute for Health Research (NIHR) was obtained by US, JM and ICC. Funding from the NIHR Biomedical Research Centre (BRC) was obtained by SB, JM, MK, OGO’D, ICC and US. JM, SB and US registered the trial on the International Standard Randomised Controlled Trial Number (ISRCTN) registry. JM, SB, MK, US and BD were involved in participant recruitment. BD, SB, JM, MK, JW and SJR were involved in data collection. rTMS treatment was provided by BD, SB, JM and MK. OGO’D, MK, JW, SJR, SB, JM, ICC and US contributed to the design and conception of the study. All authors were involved in drafting, critiquing and approving of the manuscript and accept responsibility for the accuracy and integrity of this work.

    • Funding This work was supported by a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) grant (RB-PG-1013-32049) and Infrastructure Support for Pilot studies from the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust (SLaM) and King’s College London. This paper presents independent research funded by the NIHR under its RfPB Programme (Grant Reference Number PB-PG-1013-32049).

    • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests OGO receives salary support from an NIHR Infrastructure grant for the Wellcome Trust/KCL Clinical Research Facility. Ulrike Schmidt is supported by an NIHR Senior Investigator Award. US, ASD and ICC receive salary support from the NIHR Mental Health BRC at SLaM NHS Foundation Trust and KCL.

    • Patient consent Obtained.

    • Ethics approval Ethical approval was given by the London – City Road & Hampstead Research Ethics Committee (ref: 15/LO/0196).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.

    • Author note The study protocol was published prior to recruitment.