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rTMS and Body Shape Perception (STIMOREX)

This study is currently recruiting participants.
Verified December 2016 by University Hospital, Rouen
Sponsor:
ClinicalTrials.gov Identifier:
NCT01717079
First Posted: October 30, 2012
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  Purpose

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.


Condition Intervention
Anorexia Nervosa Procedure: Sham rTMS Procedure: rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • BSQ-34 scale (Body Shape Questionnaire) [ Time Frame: Just after rTMS ]

Secondary Outcome Measures:
  • EAT-40 scale (eating attitude test) [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ]
  • BULIT scale (bulimia test) [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ]
  • EDI-2 scale (eating disorder inventory) [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ]
  • 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 ]
  • 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 ]
  • The body mass index [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ]
  • body composition analysis using dual energy X-ray absorptiometry [ Time Frame: Before rTMS and 3 months after rTMS ]
  • autoantibodies against alpha-melanocyte stimulating hormone [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ]
  • The adverse effects [ Time Frame: After rTMS ]
  • Weight [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ]
  • BSQ-34 scale (Body Shape Questionnaire) [ Time Frame: Before rTMS, 15 days after rTMS and 3 months after rTMS ]

Estimated Enrollment: 54
Study Start Date: May 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717079


Locations
France
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: Nathalie Chastan, MDPHD       nathalie.chastan@chu-rouen.fr   
Principal Investigator: Nathalie Chastan         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Nathalie CHASTAN, MD UH Rouen
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01717079     History of Changes
Other Study ID Numbers: 2011/122/HP
First Submitted: September 24, 2012
First Posted: October 30, 2012
Last Update Posted: December 7, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders