Extrait

Background and study aims Anorexia nervosa (AN) is a disabling and deadly disorder. After about 3-5 years, 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 that has been used successfully to treat psychiatric disorders, such as depression. rTMS appears to increase the brain’s ability to form new nerve connections, and hence it is thought to be of value in chronic or treatment-resistant mental disorders. We have shown that a single session of rTMS can temporarily reduce eating disorder symptoms. We have also treated five cases of enduring and treatment-resistant AN with 20 sessions of rTMS, with all individuals showing sustained improvements in eating disorder symptoms and mood. The proposed study is a randomised control feasibility trial investigating rTMS as an adjunct to treatment for AN. The study will compare the effect of 20 sessions of real vs. sham (placebo) rTMS over a 4 week period in adults with severe and enduring AN, using a number of neuroimaging measures to explore the neural mechanisms underlying the treatment effect. This is a clinical trial of a potential new treatment for AN. As such, although we hope there will be, we do not know whether there will be any benefits to participants in terms of symptom improvement. In the long-term, this research will help us develop improved treatments for AN. Who can participate? Right handed adults (aged at least 18) with a BMI between 14 and 18.5 kg/m2 and diagnosed with AN. What does the study involve? Participants are allocated at random to receive 20 sessions of either real rTMS or a sham version of this treatment in addition to their usual treatment (~1 hr per weekday for 4 weeks). We measure weight, eating disorder symptoms, mood and other outcomes before, during and after treatment and 3-months later to assess treatment success. With the help of two brain scans (one before and one after treatment) we assess how rTMS impacts on brain processes thought to underlie the symptoms of AN. Finally, we also ask participants about their experience of this treatment. Participants assigned to the sham condition are offered real rTMS after they have completed their involvement in the study. What are the possible benefits and risks of participating? Participants may find the procedures slightly uncomfortable. In that case, participants are free to withdraw from the study at any time without the need to justify their decision. If a participant decides to withdraw from the study, this will not affect the treatment they receive. The most common side effect of rTMS is mild discomfort in the head beneath the magnetic coil. Some people suffer a mild headache, which is treatable with simple painkillers such as paracetamol. The most serious side effect, but a very rare one (less than 1% likelihood in healthy people), is an epileptic seizure. None of our previous participants have experienced a seizure during rTMS. We will complete a safety questionnaire to exclude circumstances that would be associated with an increased risk for a seizure. We will also monitor participants' blood electrolyte levels before and during the study, as altered electrolyte levels may increase seizure risk. rTMS might induce a slight change to the structure and/or function of the brain (e.g. hormone levels), and participants may experience a temporary difference in their thoughts and/or mood. We will be checking this by examining changes in their performance on computerised tasks and by comparing brain scans taken before and after receiving rTMS treatment. Lastly, although rTMS is used widely in research and clinical settings, there is still the possibility of some, as yet unknown, side effects of the intervention. We will frequently assess any discomfort participants may experience throughout their involvement in the trial. MRI scanning is a safe scanning technique. Prior to the scan, participants will complete a screening questionnaire to make sure it is safe for them to go in the scanner. There is the possibility that an abnormality will be found in participants’ brain scan. These are called incidental findings and are found in about 4% of people who have a scan done. A limited assessment of the MRI scans will be performed by a specialist – identification of a major abnormality that requires action will be reported to the participants’ doctor (as specified on their MRI consent form). The study investigators will be informed that the participant’s GP has been contacted, but will not be told the exact nature of the abnormality. In such an event, we will have to withdraw the participant from the study to ensure their safety. Participants will be compensated £10 for their time on the days of their pre-, post-treatment and follow-up testing sessions. They will also be compensated up to £5 for their travel expenses on all study and treatment days. Where is the study run from? Maudsley Hospital, London and Institute of Psychiatry, Psychology and Neuroscience, King's College London (UK) When is the study starting and how long is it expected to run for? August 2015 to June 2017 Who is funding the study? This study is funded by the National Institute of Health Research and the South London and Maudsley NHS FoundationTrust Biomedical Research Centre. Who is the main contact? Savani Bartholdy [email protected]

Critère d'inclusion

• Topic: Mental Health; Subtopic: Eating disorders; Disease: Eating disorders

Liens

• isrctn
• ictrp