UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020881 |
|---|---|
| Receipt number | R000024096 |
| Scientific Title | Investigation of neural mechanisms underlying subjective experiences using fMRI |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2016/09/27 09:45:16 |
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Basic information
Public title
Investigation of neural mechanisms underlying subjective experiences using fMRI
Acronym
Investigation of neural mechanisms underlying subjective experiences using fMRI
Scientific Title
Investigation of neural mechanisms underlying subjective experiences using fMRI
Scientific Title:Acronym
Investigation of neural mechanisms underlying subjective experiences using fMRI
Region
| Japan |
Condition
Condition
Only healthy subjects
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate neural mechanisms on subjective experiences using functional MRI and cognitive tasks related subjectivity.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to elucidate neural mechanisms on subjective experiences using functional MRI and cognitive tasks related subjectivity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of BOLD finals in brain regions related to subjective experiences
Key secondary outcomes
Responses in cognitive tasks related to subjective experiences
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
| Other |
Interventions/Control_1
1)functional MRI
once, 60min
2)behavioral tasks
once, 60min
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
1 Subjects without any severe physical illness or psychiatric illness.
2 Subjects without ability to make informed consent
3 20 y.o.<=Age<=40 y.o., normal male and female subjects
Key exclusion criteria
1 Subjects with metallic medical device in the body
2 Subjects with severe claustrophobia
3 Pregnant women
4 Subjects with breast feeding
5 Subjects who was considered to be inappropriate to participate in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makiko Yamada |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3251
myamada@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Takahata |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3251
Homepage URL
takahata.keisuke@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
a consignment expense for Molecular Imaging
Program on "Research Base for PET diagnosis" from the Ministry of Education,
Culture, Sports, Science and Technology (MEXT), Japanese Government
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 02 | 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
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 08 | 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 | 02 | Month | 04 | Day |
Last modified on
| 2016 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024096
