rTMS and Body Shape Perception

NCT01717079 | Terminated

• 1 other identifier: 2011/122/HP
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• BSQ-34 scale (Body Shape Questionnaire)

  Just after rTMS

Secondary Outcomes (11)

• 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

Study Arms (2)

Effective arm

ACTIVE COMPARATOR

Effective coil

Procedure: rTMS

Placebo arm

PLACEBO COMPARATOR

Placebo coil

Procedure: Sham rTMS

Interventions

Sham rTMS PROCEDURE

120 pulses 0.2Hz

Placebo arm

rTMS PROCEDURE

120 pulses 0.2Hz

Effective arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Nathalie CHASTAN, MD

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: October 30, 2012
• Study Start: May 1, 2013
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

FR (1)