UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031226 |
|---|---|
| Receipt number | R000035651 |
| Scientific Title | A cognitive neuroimaging study using MRI: establishment of a measurement protocol for healthy controls |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/08/15 14:01:48 |
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Basic information
Public title
A cognitive neuroimaging study using MRI: establishment of a measurement protocol for healthy controls
Acronym
A cognitive neuroimaging study using MRI
Scientific Title
A cognitive neuroimaging study using MRI: establishment of a measurement protocol for healthy controls
Scientific Title:Acronym
A cognitive neuroimaging study using MRI
Region
| Japan |
Condition
Condition
healthy control
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) Establishment of a cognitive neuroimaging protocol using MRI, (2) Basic scientific research by healthy controls
Basic objectives2
Others
Basic objectives -Others
(1) We establish a measurement protocol for a cognitive neuroimaging study using MRI in our site.
(2) We combine MRI measurements with cognitive neuropsychological tests/behavioral tests to examine the relationships between imaging data and the test scores including those for hand preferences and various cognitive performances.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI (fMRI, diffusion imaging, structural images), hand preference scores, reaction time, developmental disorder inventory scores, mental health indices, working memory scores
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI scans
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects with no psychoneurological disorders aged 18 or over
Key exclusion criteria
people who are not to undergo MRI
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kayako |
| Middle name | |
| Last name | Matsuo |
Organization
Dokkyo Medical University
Division name
Center for Research Collaboration and Support
Zip code
321-0293
Address
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-86-1111(5692)
kayako@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kayako |
| Middle name | |
| Last name | Matsuo |
Organization
Dokkyo Medical University
Division name
Center for Research Collaboration and Support
Zip code
321-0293
Address
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-86-1111(5692)
Homepage URL
kayako@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University, Center for Research Collaboration and Support
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
Dokkyo Medical University, Research Support Section
Address
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
Tel
0282-86-1111
kenkyu@dokkyomed.ac.jp
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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
83
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2022 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035651
