Anorexia nervosa Mental and Behavioural Disorders Anorexia nervosa
Conditions
Interventions
In the RCT, 64 participants will be randomised to receive real or sham rTMS in a parallel group double blind design. Ten participants from the RCT will do the feasibility study of 20 sessions of real
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female participants who are aged 18 to 40 2. Body mass index (BMI) between 14 and 18.5 kg/m2 3. Current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSMIV) diagnosis of AN Restricting type (ANR), AN Binge/purging type (ANBP) or EDNOS anorexia type (EDNOSAN) (EDNOS: Eating Disorder Not Otherwise Specified)
Exclusion criteria
Exclusion criteria: 1. Having a history of head or eye injury 2. Having a history of a neurological disease including previous seizures of any kind 3. Having metallic implants in the head 4. Being dominantly left-handed 5. Being on a dose of any psychotropic medication that has not been stable for at least 14 days prior to participation in the study 6. Taking antipsychotic medication 7. Taking anticonvulsive medication 8. Being pregnant 9. Smoking more than 10 cigarettes /day 10. Having a current other major psychiatric disorder (e.g. major depressive disorder, substance dependence, schizophrenia or bipolar disorder) needing treatment in its own right 11. Severe abnormalities in their blood test during the month prior to the study 12. An rTMS safety questionnaire will also be administered and if considered not safe to deliver rTMS, people will subsequently be excluded on this basis
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary aims of the RCT is to investigate the effects of rTMS on a) performance in neuropsychological tasks, b) stress levels as measured by cortisol (a stress hormone that can be measured in saliva). In addition, we will investigate the acceptability and tolerability of rTMS in people with AN. The secondary outcome measures used to asses these are a computerised delayed discounting task, salivettes which collect saliva samples when chewed and VAS which asses tolerance and acceptability of rTMS. | — |
Primary
| Measure | Time frame |
|---|---|
| The specific aim of both the RCT and the case series is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on preoccupation with food, eating, weight and shape in people with Anorexia Nervosa (AN). The primary outcome measures used to asses this are Visual Analogue Scale (VAS) measuring levels of stress, anxiety, urge restrict, urge exercise, feeling fullness and feeling fat. In addition, the Depression Anxiety Stress Scale (DASS) and Eating Disorders Examination Questionnaire (EDE-Q) will be primary outcome measures in the feasibility case series study. | — |
Countries
United Kingdom
Outcome results
None listed