UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of effect of repetetive transcranial magnetic stimulation for eating disorders assessed with near infrared spectroscopy
Title of the study (Brief title)	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	Masaomi Iyo
Organization	Chiba University
Division name	Graduate school of medicine
Address	1-8-1 Inohana, Chuo, Chiba, Chiba
TEL	043-226-2146
Email	iyom@faculty.chiba-u.jp

Public contact
Name of contact person	Michiko Nakazato
Organization	Chiba University
Division name	Research center for child mental development
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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