rTMS and Body Shape Perception (STIMOREX)

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

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.

Study Overview

• Status: Terminated
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Procedure: rTMS; Procedure: Sham rTMS

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • ROUEN university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Effective arm; Effective coil	Procedure: rTMS; 120 pulses 0.2Hz
Placebo Comparator: Placebo arm; Placebo coil	Procedure: Sham rTMS; 120 pulses 0.2Hz

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Nathalie CHASTAN, MD, UH Rouen

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 2011/122/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No