rTMS and Body Shape Perception

Study Overview
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Brief Summary
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Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being fat even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. Body weight and shape dissatisfaction is linked to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rTMS. The aim of this study was to investigate the effect of excitatory high-frequency rTMS over the hypoactive inferior parietal cortex of 54 patients with AN. This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000 ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rTMS. Assessments will be performed before rTMS and after the last rTMS session (immediately after, at 15 days and three months). The principal criteria for judgement is a body image satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker for eating disorders recently described). Inferior parietal cortex rTMS could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. Also positive results could have direct therapeutic implications with the possibility to complete regular rTMS sessions, or to implant extradural electrodes for chronic parietal cortex stimulation.

Official Title
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Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Procedure: Sham rTMS
* Procedure: rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age above 18 Restrictive anorexia nervosa with a disease duration more than one year and less than three years. Body Mass Index below 16 Patient receiving or having received optimal treatment for anorexia nervosa Right-handed Normal blood ionogramme Previous stable antidepressor treatment for one month and no expected modification in the three following months Patients arriving by car with someone else or by public transportation Exclusion Criteria: Pregnancy Contraindication to transcranial magnetic stimulation i.e. pace-maker, cardiac valve protheses, metallic protheses etc. History of epileptic seizure Cerebral lesion of any etiology (post-traumatic, tumoral, vascular etc.) History of previous rTMS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Effective arm<br>Effective coil | Procedure: rTMS<br>* 120 pulses 0.2Hz<br>|
| Placebo Comparator: Placebo arm<br>Placebo coil | Procedure: Sham rTMS<br>* 120 pulses 0.2Hz<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BSQ-34 scale (Body Shape Questionnaire) |  | Just after rTMS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EAT-40 scale (eating attitude test) |  | Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS | 
| BULIT scale (bulimia test) |  | Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS | 
| EDI-2 scale (eating disorder inventory) |  | Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS | 
| Hamilton scale |  | Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMSBefore rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS | 
| Quality of Life Scale, MOS 36 Item Short-Form Health Survey or SF-36 |  | Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS | 
| The body mass index |  | Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS | 
| body composition analysis using dual energy X-ray absorptiometry |  | Before rTMS and 3 months after rTMS | 
| autoantibodies against alpha-melanocyte stimulating hormone |  | Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS | 
| The adverse effects |  | After rTMS | 
| Weight |  | Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS | 
| BSQ-34 scale (Body Shape Questionnaire) |  | Before rTMS, 15 days after rTMS and 3 months after rTMS |