Repetitive transcranial magnetic stimulation (rTMS) in treatment resistant eating disorders: a randomised, sham-controlled trial
Phase 2
- Conditions
- patients with a Diagnostic and Statistical Manual for Mental Disorders (DSM-5)diagnosis of Bulimia Nervosa (BN), or Anorexia Nervosa binge-purging type(ANBP), or Binge Eating Disorder (BED)
- Registration Number
- JPRN-UMIN000015979
- Lead Sponsor
- Chiba University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
Past history of brain injury with disturbance of consciousness, with heart pace-maker, pregnancy, nicotine use exceeding the equivalent of >10 cigarettes/ day, substance dependence, mental retardation, personality disorders, severe infection, cancer, physical illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure, administered before and after the rTMS sessions, is the change in a 10-cm visual analogue scale (VAS) of "urge to eat".
- Secondary Outcome Measures
Name Time Method 1. the change in a VAS of urge to binge-eat 2. the change in a VAS of level of hunger 3. the change in a VAS of level of anxiety 4. the change in a VAS of level of tension 5. the change in a VAS of current mood 6. the Food Craving Questionnaire-State (FCQ-S) scores 7. the Bulimic Investigatory Test, Edinburgh (BITE) 8. the Hamilton Depression Rating Scale 9. the Hamilton Anxiety Rating Scale 10. the Clinical Global Impression Scale Severity/Change(CGIS/CGIC) 11. the Global Assessment of Functioning(GAF) 12. the Eating Disorder Examination Questionnaire(EDEQ) 13. the Eating Disorder Inventory2(EDI2) 14. the Hospital Anxiety and Depression Scale(HADS) 15. the Cognitive Flexibility Scale(CSF) 16. neurocognitive tasks(the stroop test, Brixton test,Trail-making test) 17. Serum levels of BDNF, proBDNF 18. Event-related potential(ERP) 19. Skin conductance response(SCR) 20. the State-Trait Anger eXpression Inventory (STAXI)