Extrait

Background and study aims Anorexia Nervosa (AN) is a serious disorder with often devastating consequences. Treatment outcomes are poor with only about 3 out of 10 in remission after one year of specialist treatment. Thus there is a strong need for new treatment strategies. From several studies evidence is emerging that self regulatory ability is weakened in a range of neuropsychiatric disorders, including AN. This could be a consequence of developmental dysfunction in fronto-striatal circuits (neural pathways in brain). High frequency repetitive transcranial stimulation (rTMS) improve self regulatory control and thus symptomatology in disorders that have a fronto-striatal dysfunction, such as bulimia nervosa or obsessive compulsive disorders. The specific aims of this two part study are firstly, to conduct as study to investigate the effects of one session of repetitive transcranial magnetic stimulation (rTMS) compared to sham rTMS in reducing negative emotions and preoccupation toward food and shape. This could increase food intake by increasing self regulatory control over compensatory behaviours such as restriction. This extends our recent findings of increased self-regulatory control as expressed by reduced craving and binge eating in people with a bulimic eating disorder. Secondly, a feasibility case series study will also be conducted in which a small number of individuals with AN will be offered 20 sessions (3 days per week) of rTMS over 6 weeks in order to establish whether a longer, therapeutic delivery of rTMS improves self-regulatory control over eating. Who can participate? In order to be eligible to take part in the study participants must be over the age of 18, right-handed and have a current diagnosis of Anorexia Nervosa or EDNOS-anorexia type (EDNOS: Eating Disorder Not Otherwise Specified). What does the study involve? Participation involves having a MRI brain scan and a real or sham (placebo) rTMS session. In order to detect the effects of rTMS not all participants will receive real rTMS, that is half of the participants will receive a sham (placebo) rTMS stimulation. This will be a random allocation and participants will not be aware of which (real or sham) stimulation they receive, however will be informed upon completion of the study. Participants will also be required to complete a number of questionnaires (assessing mood and eating habits), ratings in relation to different food types and a neuropsychological task (brain puzzle) immediately before and after the stimulation session. We will also collect saliva samples to measure cortisol (this is a stress hormone). What are the possible benefits and risks of participating? The most common side effect of rTMS is a mild discomfort in the scalp beneath the magnetic coil, but some people also referred to a mild headache (easily treated with simple analgesic drugs). The magnetic coil makes loud clicks during treatment that are not loud enough to harm hearing, but patients will be asked to wear earplugs as a precaution. The coil can be changed during the procedure because it may warm up. This would only be slightly above body temperature and would never cause skin or hair damage. An inbuilt safety mechanism in the machine makes it switch off automatically when it has reached 40 degrees Celsius. Although the rTMS is seen as a safe procedure, the most serious side effect reported, though very rare, is a seizure. Regarding cardiac safety of the procedure, we have observed this procedure to be safe in people with bulimic disorders. The rTMS Adult Safety Screen will be done before rTMS and a final evaluation of discomfort with the rTMS procedure will also be done with another VAS (none to extreme discomfort). In addition, a list of side effects that have been reported with rTMS as recommended by the Safety of TMS Consensus Group will be checked. There are no risks associated with the administration of the interviews, neuropsychological tests and other questionnaires or saliva collection. No specific benefit is expected besides a possible reduction in their self regulatory control over behavioural symptoms such as food restriction. Nonetheless, the latter is expected to be relatively brief in duration for individuals participating in the RCT (hours) however slightly longer for those participating in the case series (days/weeks). Where is the study run from? Participants will be recruited from the outpatients eating disorder service at the Maudsley hospital, and via advertisements on the b-eat (national eating disorder charity) website. The testing will be conducted at the Institute of Psychiatry, London. When is the study starting and how long is it expected to run for? We expect to recruit and test participants from February 2013 up until September 2014. Who is funding the study? Eating Disorders Unit, Institute of Psychiatry, King's College London (UK) - Departmental funds Who is the main contact? Ms Jessica McClelland [email protected]

Critère d'inclusion

• Anorexia nervosa

Liens

• ictrp
• isrctn