rTMS and Body Shape Perception (STIMOREX)
Primary Purpose
Anorexia Nervosa
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sham rTMS
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
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
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Effective arm
Placebo arm
Arm Description
Effective coil
Placebo coil
Outcomes
Primary Outcome Measures
BSQ-34 scale (Body Shape Questionnaire)
Secondary Outcome Measures
EAT-40 scale (eating attitude test)
BULIT scale (bulimia test)
EDI-2 scale (eating disorder inventory)
Hamilton scale
Quality of Life Scale, MOS 36 Item Short-Form Health Survey or SF-36
The body mass index
body composition analysis using dual energy X-ray absorptiometry
autoantibodies against alpha-melanocyte stimulating hormone
The adverse effects
Weight
BSQ-34 scale (Body Shape Questionnaire)
Full Information
NCT ID
NCT01717079
First Posted
September 24, 2012
Last Updated
May 25, 2018
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT01717079
Brief Title
rTMS and Body Shape Perception
Acronym
STIMOREX
Official Title
Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Protocol stopped for safety reason
Study Start Date
May 2013 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Effective arm
Arm Type
Active Comparator
Arm Description
Effective coil
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo coil
Intervention Type
Procedure
Intervention Name(s)
Sham rTMS
Intervention Description
120 pulses 0.2Hz
Intervention Type
Procedure
Intervention Name(s)
rTMS
Intervention Description
120 pulses 0.2Hz
Primary Outcome Measure Information:
Title
BSQ-34 scale (Body Shape Questionnaire)
Time Frame
Just after rTMS
Secondary Outcome Measure Information:
Title
EAT-40 scale (eating attitude test)
Time Frame
Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Title
BULIT scale (bulimia test)
Time Frame
Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Title
EDI-2 scale (eating disorder inventory)
Time Frame
Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Title
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
Title
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
Title
The body mass index
Time Frame
Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Title
body composition analysis using dual energy X-ray absorptiometry
Time Frame
Before rTMS and 3 months after rTMS
Title
autoantibodies against alpha-melanocyte stimulating hormone
Time Frame
Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Title
The adverse effects
Time Frame
After rTMS
Title
Weight
Time Frame
Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Title
BSQ-34 scale (Body Shape Questionnaire)
Time Frame
Before rTMS, 15 days after rTMS and 3 months after rTMS
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie CHASTAN, MD
Organizational Affiliation
UH Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
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rTMS and Body Shape Perception
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