UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024139 |
|---|---|
| Receipt number | 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 16:21:41 |
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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
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
michiko.nakazato@nifty.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027770
