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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name