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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003888
Receipt No. R000004680
Scientific Title Investigation of cognitive change using MRI and neuropsychological measurements
Date of disclosure of the study information 2010/07/08
Last modified on 2014/08/29

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Basic information
Public title Investigation of cognitive change using MRI and neuropsychological measurements
Acronym Investigation of cognitive change using MRI
Scientific Title Investigation of cognitive change using MRI and neuropsychological measurements
Scientific Title:Acronym Investigation of cognitive change using MRI
Region
Japan

Condition
Condition Healthy individuals
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate neural mechanism of cognitive change.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BOLD signals related to cognitive change
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 Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 functional MRI
structural MRI
neuropsychological measurements
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
40 years-old >
Gender Male and Female
Key inclusion criteria Healthy individuals who have the ability to provide informed concent.
Key exclusion criteria Individuals who have histories of psychiatric disorders including drug dependence and/or serious medical illness.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Obata
Organization National Institute of Radiological Sciences
Division name Biophysics group, Molecular Imaging Center
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba, 265-8555, Japan
TEL 043-206-3406
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Matsuzawa
Organization Graduate School of Medicine, Chiba University
Division name Department of Cognitive Behavioral Physiology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-226-2027
Homepage URL
Email

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 913
Org. issuing International ID_1 Graduate School of Medicine, Chiba University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 08 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 Completed
Date of protocol fixation
2010 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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
2010 Year 07 Month 08 Day
Last modified on
2014 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004680

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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