rTMS and Body Shape Perception (STIMOREX)

University Hospital, Rouen

Status: Terminated

Conditions: Anorexia Nervosa

Treatments: Procedure: Sham rTMS; Procedure: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT01717079

2011/122/HP

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

22 participants in 2 patient groups, including a placebo group

Effective arm

Active Comparator group

Description:

Effective coil

Treatment:

Procedure: rTMS

Placebo arm

Placebo Comparator group

Description:

Placebo coil

Treatment:

Procedure: Sham rTMS