UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027579 |
|---|---|
| Receipt number | R000031378 |
| Scientific Title | A study of relationships between hierarchical sequence processing and executive function |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2021/12/03 11:23:21 |
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Basic information
Public title
A study of relationships between hierarchical sequence processing and executive function
Acronym
A study of hierarchical sequence processing
Scientific Title
A study of relationships between hierarchical sequence processing and executive function
Scientific Title:Acronym
A study of hierarchical sequence processing
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and neural mechanism of fMRI neurofeedback on hierarchical sequence processing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral performance in fMRI neurofeedback tests
Key secondary outcomes
Structural and functional MRI data
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
fMRI scanning and neurofeedback
Up to 4 days, within 90 min per day
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged 20-35 years-old, male and female
2) Capability of informed consent
3) Right-handedness
4) Native Japanese speaker
Key exclusion criteria
1) Individuals with a neuropsychological, psychiatric or neurosurgical history
2) Individuals who are unable to undergo MRI
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Iwabuchi |
Organization
Hamamatsu University School of Medicine
Division name
Research Center for Child Mental Development
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192 Japan
TEL
053-435-2331
iwabuchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiki Iwabuchi |
Organization
Hamamatsu University School of Medicine
Division name
Research Center for Child Mental Development
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192 Japan
TEL
053-435-2331
Homepage URL
iwabuchi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
Graduate School of Letters, Hokkaido University
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
| 2017 | Year | 06 | Month | 01 | 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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031378
