## Protocol Section
### Identification Module
**NCT ID:** NCT01717079

**Acronym:** STIMOREX

**Brief Title:** rTMS and Body Shape Perception

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

#### Organization Study ID Info
**ID:** 2011/122/HP
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Rouen
### Status Module
#### Completion Date
**Date:** 2017-12-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2018-05-25

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2017-12-15

**Type:** ACTUAL

#### Start Date
**Date:** 2013-05

**Type:** ACTUAL

**Status Verified Date:** 2018-05

#### Study First Post Date
**Date:** 2012-10-30
**Type:** ESTIMATED
**Study First Submit Date:** 2012-09-24
**Study First Submit QC Date:** 2012-10-29
**Why Stopped:** Protocol stopped for safety reason
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Rouen

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Anorexia Nervosa

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 22

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Effective coil

**Intervention Names:**

- Procedure: rTMS

**Label:** Effective arm

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Placebo coil

**Intervention Names:**

- Procedure: Sham rTMS

**Label:** Placebo arm

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Placebo arm

**Description:** 120 pulses 0.2Hz

**Name:** Sham rTMS

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Effective arm

**Description:** 120 pulses 0.2Hz

**Name:** rTMS

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** BSQ-34 scale (Body Shape Questionnaire)

**Time Frame:** Just after rTMS

#### Secondary Outcomes

**Measure:** EAT-40 scale (eating attitude test)

**Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS

**Measure:** BULIT scale (bulimia test)

**Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS

**Measure:** EDI-2 scale (eating disorder inventory)

**Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS

**Measure:** Hamilton scale

**Time Frame:** 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

**Measure:** Quality of Life Scale, MOS 36 Item Short-Form Health Survey or SF-36

**Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS

**Measure:** The body mass index

**Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS

**Measure:** body composition analysis using dual energy X-ray absorptiometry

**Time Frame:** Before rTMS and 3 months after rTMS

**Measure:** autoantibodies against alpha-melanocyte stimulating hormone

**Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS

**Measure:** The adverse effects

**Time Frame:** After rTMS

**Measure:** Weight

**Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS

**Measure:** BSQ-34 scale (Body Shape Questionnaire)

**Time Frame:** Before rTMS, 15 days after rTMS and 3 months after rTMS

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rouen

**Country:** France

**Facility:** Rouen University Hospital

**Zip:** 76031

#### Overall Officials

**Official 1:**

**Affiliation:** UH Rouen

**Name:** Nathalie CHASTAN, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000001068

- Term: Feeding and Eating Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M4181

- Name: Anorexia

- Relevance: HIGH

- As Found: Anorexia

- ID: M4182

- Name: Anorexia Nervosa

- Relevance: HIGH

- As Found: Anorexia Nervosa

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M4380

- Name: Feeding and Eating Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000855

- Term: Anorexia

- ID: D000000856

- Term: Anorexia Nervosa

### Misc Info Module

- Version Holder: 2024-05-24
