rTMS and Body Shape Perception

Anorexia Nervosa Clinical Trial

— STIMOREX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01717079
• Other study ID #: 2011/122/HP
• Status: Terminated
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 15, 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Procedure:
• Sham rTMS
120 pulses 0.2Hz
• rTMS
120 pulses 0.2Hz

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BSQ-34 scale (Body Shape Questionnaire)		Just after rTMS
Secondary	EAT-40 scale (eating attitude test)		Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Secondary	BULIT scale (bulimia test)		Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Secondary	EDI-2 scale (eating disorder inventory)		Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Secondary	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
Secondary	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
Secondary	The body mass index		Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Secondary	body composition analysis using dual energy X-ray absorptiometry		Before rTMS and 3 months after rTMS
Secondary	autoantibodies against alpha-melanocyte stimulating hormone		Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Secondary	The adverse effects		After rTMS
Secondary	Weight		Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Secondary	BSQ-34 scale (Body Shape Questionnaire)		Before rTMS, 15 days after rTMS and 3 months after rTMS