UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051759 |
|---|---|
| Receipt number | R000059070 |
| Scientific Title | Investigation of Cognitive characteristics related to learning difficulties by using fMRI |
| Date of disclosure of the study information | 2023/07/31 |
| Last modified on | 2023/07/31 11:08:34 |
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Basic information
Public title
Investigation of Cognitive characteristics related to learning difficulties by using functional magnetic resonance imaging (fMRI) during rest and task
Acronym
Investigation of Cognitive characteristics related to learning difficulties by using fMRI
Scientific Title
Investigation of Cognitive characteristics related to learning difficulties by using fMRI
Scientific Title:Acronym
Investigation of Cognitive characteristics related to learning difficulties by using fMRI
Region
| Japan |
Condition
Condition
Neuro-developmental disorder
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Current research investigates cognitive characteristics and brain functions in children who have learning difficulties with Neuro-developmental disorder, very low birth weight, and typical development by using functional magnetic resonance imaging (fMRI) during rest and task, intelligence test, cognitive test, and reading/writing test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
functional magnetic resonance imaging (fMRI)
cognitive test
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
| Device,equipment |
Interventions/Control_1
functional magnetic resonance imaging (fMRI) during rest and task, intelligence test, cognitive test, and reading/writing test
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
| 9 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Neuro-developmental disorder:4th-9th graders with Neuro-developmental disorder and based on diagnostic criteria of DSM-5
2.Typically developing children:4th-9th graders without diagnosis related to Neuro-developmental disorder and higher brain dysfunction
3.Very low birth weight:4th-9th graders without diagnosis born with very low birth weight (2500g or less)
Key exclusion criteria
contraindication to fMRI testing.
a past medical history of neuropsychiatric disorders, visual impairment, and hearing impairment.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomohito |
| Middle name | |
| Last name | Okumura |
Organization
Osaka Medical and Pharmaceutical University
Division name
Child Higher Brain Function Research Institute
Zip code
569-8686
Address
2-7 Daigaku-machi Takatsuki-shi
TEL
072-684-6236
tomohito.okumura@ompu.ac.jp
Public contact
Name of contact person
| 1st name | tomohito |
| Middle name | |
| Last name | okumura |
Organization
Osaka Medical and Pharmaceutical University
Division name
Child Higher Brain Function Research Institute
Zip code
569-8686
Address
2-7 Daigaku-machi Takatsuki-shi
TEL
0726846236
Homepage URL
tomohito.okumura@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University ethics committee
Address
2-7 Daigaku-machi Takatsuki-shi,Osaka
Tel
0726846236
tomohito.okumura@ompu.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
| 2023 | Year | 07 | Month | 31 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059070
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
