A Randomised Controlled Trial of Neuronavigated Repetitive Transcranial Magnetic Stimulation (rTMS) in Anorexia Nervosa

IntroductionWhile multiple pharmacological and non-pharmacological interventions treating chronic non-specific low back pain (CLBP) are available, they have been shown to produce at best modest effects. Interventions such as repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, have exhibited promising results to alleviate chronic pain. However, evidence on the effectiveness of rTMS for CLBP is scarce due to limited rigorous clinical trials. Combining rTMS with motor control exercises (MCE) may help to address both central and nociceptive factors contributing to the persistence of LBP. The primary aim of this randomised controlled trial is to compare the effectiveness of a combination of rTMS and MCE to repeated rTMS sessions alone, sham rTMS and a combination of sham rTMS and MCE on pain intensity.Methods and analysisOne hundred and forty participants (35/group) with CLBP will be randomised into four groups (active rTMS+MCE, sham rTMS+MCE, active rTMS and sham rTMS) to receive 10 sessions of their allocated intervention. The primary outcome will be the pain intensity, assessed at baseline, 4, 8, 12 and 24 weeks. Secondary outcomes will include disability, fear of movement, quality of life and patient global rating of change.Ethics and disseminationEthics approval was obtained from the Comité d’éthique de la recherche sectoriel en réadaptation et intégration sociale, CIUSS de la Capitale Nationale in June 2019 (#2020–1844 – CER CIUSSS-CN). The results of the study will be submitted to a peer-reviewed journal and scientific meetings.Trial registration numberNCT04555278.

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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

BMJ Open ◽

10.1136/bmjopen-2018-021531 ◽

2018 ◽

Vol 8 (7) ◽

pp. e021531 ◽

Cited By ~ 19

Author(s):

Bethan Dalton ◽

Savani Bartholdy ◽

Jessica McClelland ◽

Maria Kekic ◽

Samantha J Rennalls ◽

...

Keyword(s):

Quality Of Life ◽

Anorexia Nervosa ◽

Eating Disorder ◽

Magnetic Stimulation ◽

Repetitive Transcranial Magnetic Stimulation ◽

Controlled Trial ◽

Eating Disorder Symptoms ◽

Randomised Controlled

ObjectiveTreatment 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.DesignDouble-blind, parallel group, two-arm, sham-controlled trial.SettingSpecialist eating disorders centre.ParticipantsCommunity-dwelling people with anorexia nervosa, an illness duration of ≥3 years and at least one previous completed treatment.InterventionsParticipants 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.OutcomesPrimary 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).ResultsThirty-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.ConclusionsThe 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 numberISRCTN14329415; Pre-results.

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