rTMS and Body Shape Perception (STIMOREX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01717079
First received: September 24, 2012
Last updated: June 18, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • BSQ-34 scale (Body Shape Questionnaire) [ Time Frame: Just after rTMS ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • BULIT scale (bulimia test) [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ] [ Designated as safety issue: No ]
  • EDI-2 scale (eating disorder inventory) [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The body mass index [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ] [ Designated as safety issue: No ]
  • body composition analysis using dual energy X-ray absorptiometry [ Time Frame: Before rTMS and 3 months after rTMS ] [ Designated as safety issue: No ]
  • autoantibodies against alpha-melanocyte stimulating hormone [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ] [ Designated as safety issue: No ]
  • The adverse effects [ Time Frame: After rTMS ] [ Designated as safety issue: Yes ]
  • Weight [ Time Frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS ] [ Designated as safety issue: No ]
  • BSQ-34 scale (Body Shape Questionnaire) [ Time Frame: Before rTMS, 15 days after rTMS and 3 months after rTMS ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: May 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: May 2016 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01717079     History of Changes
Other Study ID Numbers: 2011/122/HP
Study First Received: September 24, 2012
Last Updated: June 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 22, 2014