Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
22 participants
INTERVENTIONAL
2013-05-31
2017-12-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Effective arm
Effective coil
rTMS
120 pulses 0.2Hz
Placebo arm
Placebo coil
Sham rTMS
120 pulses 0.2Hz
Interventions
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Sham rTMS
120 pulses 0.2Hz
rTMS
120 pulses 0.2Hz
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Nathalie CHASTAN, MD
Role: PRINCIPAL_INVESTIGATOR
UH Rouen
Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2011/122/HP
Identifier Type: -
Identifier Source: org_study_id
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