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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024139
Receipt No. R000027770
Scientific Title Investigation of effect of repetetive transcranial magnetic stimulation for eating disorders assessed with near infrared spectroscopy
Date of disclosure of the study information 2016/10/11
Last modified on 2016/09/23

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Basic information
Public title Investigation of effect of repetetive transcranial magnetic stimulation for eating disorders assessed with near infrared spectroscopy
Acronym Investigation of rTMS effect for eating disorders
Scientific Title Investigation of effect of repetetive transcranial magnetic stimulation for eating disorders assessed with near infrared spectroscopy
Scientific Title:Acronym Investigation of rTMS effect for eating disorders
Region
Japan

Condition
Condition bulimia nervosa
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate pathological mechanism of bulimia nervosa and novel therapeutic approach
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) prefrontal activity assessed with cognitive task and NIRS
2) Food Craving Questionnaire-State Score (FCQS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 repetitive transcranial magnetic
stimulation on the left dorsolateral prefrontal cortex
Interventions/Control_2
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
59 years-old >=
Gender Male and Female
Key inclusion criteria Patients who met the current diagnosis of bulimia nervosa according to the Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition, Text Revision (DSM-IV-TR) criteria.
Key exclusion criteria left-handedness, personal, and close family history of seizure, neurological disorders, brain injury, suicidal ideation, pregnancy, substance abuse, severe depressive disorders, BMI<17.5 kg/m2, and use of medical equipment considered to be subject to the influence of magnetic stimulation (intracranial metal product)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Chiba University
Division name Graduate school of medicine
Zip code
Address 1-8-1 Inohana, Chuo, Chiba, Chiba
TEL 043-226-2146
Email iyom@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, Chiba, Chiba
TEL 043-226-2975
Homepage URL
Email michiko.nakazato@nifty.com

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Scholarship fund
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 23 Day
Last modified on
2016 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027770

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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