Real vs. sham rTMS in severe and enduring AN
Research type
Research Study
Full title
A sham-controlled randomised feasibility study of repetitive transcranial magnetic stimulation (rTMS) as an adjunct to treatment as usual (TAU) in adults with severe and enduring anorexia nervosa (SE-AN)
IRAS ID
168254
Contact name
Ulrike Schmidt
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Anorexia nervosa (AN) is a disabling and deadly disorder. After about 3-5 years duration, AN can be considered as enduring and difficult to change. Most adults with AN have an enduring form of the illness and, only 10-30% of adults treated with best available treatments make a full recovery. Treatment innovations are urgently needed.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation method which has been used successfully to treat psychiatric disorders, such as depression. A key mechanism of action of rTMS is that it appears to increase neuroplasticity, i.e. the ability of the brain to form new nerve connections, and hence it is thought to be of value in chronic or treatment-resistant mental disorders. We have shown in proof-of-concept studies in eating disorders that in the short-term rTMS reduces core symptoms (Claudino et al., 2011; McClelland et al., 2013a; Van den Eynde et al., 2011; Van den Eynde et al., 2010). We have also treated four cases of very severe, enduring and treatment-resistant AN with 20 sessions of rTMS, with all individuals showing marked reductions in eating disorder symptoms and mood at end of treatment and follow-up (McClelland et al., 2013b). Here, we propose to conduct a feasibility study (i.e. with the aim of assessing the practicalities of our study design) in adults with severe and enduring AN and previous unsuccessful treatment. Participants will be allocated by chance to receive either 20 sessions of real rTMS or a sham version of this treatment in addition to their usual treatment. We will measure participants’ weight, their eating disorders symptoms, mood and other outcomes, before, during and after treatment to assess treatment success. We will also ask participants about their experience of this treatment. This will give us important information to help us design a large-scale clinical trial which compares real rTMS with sham treatment, as an add-on to usual treatment in this patient group. Lastly, we will use a number of neuroimaging measures to explore the neural mechanisms underlying the treatment effect of rTMS.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/0196
Date of REC Opinion
17 Mar 2015
REC opinion
Further Information Favourable Opinion