UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019522 |
|---|---|
| Receipt number | R000022282 |
| Scientific Title | Breakthrough of the variation and age related changes of the human brain connectome |
| Date of disclosure of the study information | 2015/11/15 |
| Last modified on | 2020/04/30 09:20:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Breakthrough of the variation and age related changes of the human brain connectome
Acronym
Breakthrough of the variation and age related changes of the human brain connectome
Scientific Title
Breakthrough of the variation and age related changes of the human brain connectome
Scientific Title:Acronym
Breakthrough of the variation and age related changes of the human brain connectome
Region
| Japan |
Condition
Condition
normal subject, aging, dementia, neurodegenerative disease
Classification by specialty
| Neurology | Geriatrics | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify diversity of the brain network among individuals, the change by aging, and the relationship between brain networks and genetic factor.
Basic objectives2
Others
Basic objectives -Others
cohort study and exploratory genome analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Elucidate of brain networks and the relation of genome after observation period.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subject, no neurological deficit.
Key exclusion criteria
Mini mental state examination score less than 26, history of sever head trauma, severe depression and other brain or psychiatric diseases, contraindication of MRI; magnetic material or substance within body or pregnancy.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gen Sobue |
Organization
Nagoya university
Division name
Brain and Mind Reseach Center
Zip code
Address
65, Tsurumai-cho, Shouwa-ku, Nagoya-shi, Aichi, Japan
TEL
052-744-1975
bmrc@adm.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Watanabe |
Organization
Nagoya university
Division name
Brain and Mind research center
Zip code
Address
65, Tsurumai-cho, Shouwa-ku, Nagoya-shi, Aichi, Japan
TEL
052-744-1975
Homepage URL
bmrc@adm.nagoya-u.ac.jp
Sponsor or person
Institute
Brain and Mind Reseach Center, Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,Culture,Sports,Science and Technology
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
| 2015 | Year | 11 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Normal subjects cohort study using MRI and MEG and Genome analysis.
Management information
Registered date
| 2015 | Year | 10 | Month | 27 | Day |
Last modified on
| 2020 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022282
