UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015979 |
|---|---|
| Receipt number | R000018327 |
| Scientific Title | Repetitive transcranial magnetic stimulation (rTMS) in treatment resistant eating disorders: a randomised, sham-controlled trial |
| Date of disclosure of the study information | 2014/12/17 |
| Last modified on | 2019/02/27 21:06:49 |
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Basic information
Public title
Repetitive transcranial magnetic stimulation (rTMS) in treatment resistant eating disorders: a randomised, sham-controlled trial
Acronym
EDTMS-Chiba
Scientific Title
Repetitive transcranial magnetic stimulation (rTMS) in treatment resistant eating disorders: a randomised, sham-controlled trial
Scientific Title:Acronym
EDTMS-Chiba
Region
| Japan |
Condition
Condition
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)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this randomised sham-controlled study is to investigate the therapeutic efficacy of the left dorsolateral prefrontal cortex (DLPFC)in people with treatment resistant eating disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
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".
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We provide real high-frequency rTMS to the left DLPFC with a Magstim Rapid System(MRS)1000(Magstim Company Ltd,Wales,UK)
Interventions/Control_2
We provide sham coil to the left DLPFC.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiko Nakazato |
Organization
Chiba University Graduate School of Medicine
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba
TEL
043-226-2975
nakazato@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Nakazato |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
043-226-2975
Homepage URL
nakazato@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid-for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部付属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018327
