UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043718 |
|---|---|
| Receipt number | R000049914 |
| Scientific Title | Dense sampling MRI and brain-behavior relationships |
| Date of disclosure of the study information | 2021/03/23 |
| Last modified on | 2023/05/31 10:34:18 |
* 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
Dense sampling MRI and brain-behavior relationships
Acronym
Dense sampling MRI
Scientific Title
Dense sampling MRI and brain-behavior relationships
Scientific Title:Acronym
Dense sampling MRI
Region
| Japan |
Condition
Condition
Healthy control
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine longitudinal changes in brain-behavior relationships
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Longitudinal changes in MRI/EEG indices and psychological test indices
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
text/audio-visual learning, physical exercise
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Those who have the ability to give consent for participation in this study and who can read and understand the explanatory documents.
2.The native language of the participant must be Japanese.
Key exclusion criteria
1) Patients with a history of or complications from organic brain disease (head injury, apparent stroke, etc.) 2) Patients with complications from mental or neurological disease (including drug dependence, etc.)
2) Patients with concomitant psychiatric or neurological disorders (including drug dependence, etc.). 3) Patients with complications of serious diseases or a history of such diseases.
3. those who have complications of serious diseases, or those who have a history of such diseases and are judged by the physician who is a researcher of the Quantitative Research Institute, etc., to be unsuitable for this research. 4. those who are pregnant or have the possibility of pregnancy.
Women who are pregnant or have the potential to become pregnant. 5.
Those who have pacemakers or internal metals (brain clips, bolts, etc.). 6.
Those who have tattoos (including tattoos and art makeup). 7.
Those who are claustrophobic. 8.
Those who are color blind. 9.
9. those who are deemed unsuitable as research subjects by the researchers of the ILCAA due to their inability to follow or understand the instructions of the researchers.
A person who is judged by a physician as an inappropriate research subject for any other reason.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Matsuyoshi |
Organization
National Institutes for Quantum Science and Technology
Division name
Institute of Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba 263-8555, Japan
TEL
+81-43-206-3249
matsuyoshi.daisuke@qst.go.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Matsuyoshi |
Organization
National Institutes for Quantum Science and Technology
Division name
Institute of Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba 263-8555, Japan
TEL
+81-43-206-3249
Homepage URL
matsuyoshi.daisuke@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum 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
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage, Chiba 263-8555, Japan
Tel
043-206-4706
helsinki@qst.go.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
| 2021 | Year | 03 | Month | 23 | 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
1
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
| 2021 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 12 | 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
Management information
Registered date
| 2021 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049914
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
