UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045207 |
|---|---|
| Receipt number | R000051647 |
| Scientific Title | Neural substrate of acceptance and cognitive reappraisal in people with autism spectrum disorder |
| Date of disclosure of the study information | 2021/08/24 |
| Last modified on | 2024/08/22 10:31:49 |
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Basic information
Public title
Neural activation during acceptance and cognitive reappraisal in people with autism spectrum disorder
Acronym
Neural activation during acceptance and cognitive reappraisal in people with autism spectrum disorder
Scientific Title
Neural substrate of acceptance and cognitive reappraisal in people with autism spectrum disorder
Scientific Title:Acronym
Neural substrate of acceptance and cognitive reappraisal in people with autism spectrum disorder
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of neural activation during cognitive reappraisal and acceptance in people with autism spectrum disorder by comparing typically developing subjects.
Basic objectives2
Others
Basic objectives -Others
The purpose is to elucidate the neural activation specific to acceptance/cognitive reappraisal by comparing neural activation of those two emotional regulation strategies. In addition, we will also clarify the characteristics of brain activity related to acceptance and cognitive reappraisal in autism spectrum disorder or typically developing subject by examining the group-by-condition interaction effect.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neural activation during the emotion regulation task, measured by MRI.
Key secondary outcomes
Data from questionnaire and behavioral data during MRI task.
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
| 13 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were as follows: 1) subject's age is over 13 and under 25; 2) subject and parental authority can understand the contents of this study and express written consent to participate; 3) subject with autism spectrum disorder should be already diagnosed by clinician, and also confirmed no coexistence of intellectual disability: 4) typically developing subject have no history of mental illness.
Key exclusion criteria
Exclusion criteria were as follows: 1) subject who showed difficulty in understanding the task or questionnaire: 2) subject who have MRI contraindications.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Division of Developmental Cognitive Neuroscience
Zip code
980-8575
Address
4-1, Seiryo, Aoba, Sendai, Miyagi
TEL
022-717-8457
ryuta.kawashima.a6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Matsuzaki |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Division of Developmental Cognitive Neuroscience
Zip code
980-8575
Address
4-1, Seiryo, Aoba, Sendai, Miyagi
TEL
022-717-8457
Homepage URL
yutaka.matsuzaki.e5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology -Japan
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
Research Ethics Committee, School of Medicine, Tohoku University
Address
2-1, Seiryo, Aoba, Sendai, Miyagi
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
| 2021 | Year | 08 | Month | 24 | 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
62
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
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design is case control study. We will recruit the candidate using subject pool that the division already have from September, 2021 to March, 2023. We will measure neural activity during emotion regulation task in the MRI scanner, task performance, and questionnaire.
Management information
Registered date
| 2021 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051647
