Not provided
Not provided
Not provided
Not provided
Protocol stopped for safety reason
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effective arm | Active Comparator | Effective coil |
|
| Placebo arm | Placebo Comparator | Placebo coil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham rTMS | Procedure | 120 pulses 0.2Hz |
| |
| rTMS |
| Measure | Description | Time Frame |
|---|---|---|
| BSQ-34 scale (Body Shape Questionnaire) | Just after rTMS |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nathalie CHASTAN, MD | UH Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rouen University Hospital | Rouen | 76031 | France |
Not provided
| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
120 pulses 0.2Hz |
|
| 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 |