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)
Conditions
Interventions
We provide real high-frequency rTMS to the left DLPFC with a Magstim Rapid System(MRS)1000(Magstim Company Ltd,Wales,UK)
We provide sham coil to the left DLPFC.
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants are recruited from the Department of Psychiatry, inpatient unit or outpatient uni,t Chiba University Hospital. Diagnosis is established with the eating disorders, BN, AN or BED, based on DSM-5 criteria. 2. Participants are enrolled if they had at least six binges over the previous 28 days as assessed with the Eating Disorder Examination-Questionnaire (EDE-Q). CGI>=4. 3. Written informed consent is obtained from all the participants. 4. Participants are age between 20 and 48. 5. The criteria for treament-resistance is as follows; 1) BITE severity scores over 5, BITE symptom scores over 15, CGI-C>3, after 12 weeks intervention with sufficient dose of SSRI. 2) BITE severity scores over 5, BITE symptom scores over 15, CGI-C>3, with discontinuance of SSRI because of tolerability. 3)BITE severity scores over 5, BITE symptom scores over 15, CGI-C>3, after 12 weeks with CBT.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactMichiko Nakazato
Chiba University Research Center for Child Mental Development
Outcome results
None listed