UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022361 |
|---|---|
| Receipt number | R000025772 |
| Scientific Title | Neural basis of evaluating the affective impact of remarks on listener based on social communication context in individuals with Autism Spectrum Disorder. |
| Date of disclosure of the study information | 2016/05/19 |
| Last modified on | 2019/11/21 11:16:07 |
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Basic information
Public title
Neural basis of evaluating the affective impact of remarks on listener based on social communication context in individuals with Autism Spectrum Disorder.
Acronym
Neural basis of inferring the impact of remark in communication on listener in autism.
Scientific Title
Neural basis of evaluating the affective impact of remarks on listener based on social communication context in individuals with Autism Spectrum Disorder.
Scientific Title:Acronym
Neural basis of inferring the impact of remark in communication on listener in autism.
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the neural basis of evaluating the affective impact of remarks in communication on listener based on relation between speaker and listener.
Basic objectives2
Others
Basic objectives -Others
To reveal the specific brain region related to evaluating the affective impact of remarks in communication on listener based on relation between speaker and listener in adults with autism using functional MRI technique.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Task performance and functional brain image.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Adults with Autism Spectrum Disorder.
Interventions/Control_2
Typically developed adults.
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
| 18 | years-old | <= |
Age-upper limit
| 26 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients
1) Adults who were diagnosed as autism spectrum disorder based on DSM-IV-TR or DSM-5, and confirmed the diagnosis by AQ.
2) Adults who do not have any severe neuropsychiatric disorders and physical illness.
3) Adults whose IQs are above 70, and who can give informed consent.
Typical control
1) Adults who do not have any severe neuropsychiatric disorders and physical illness.
2) Adults whose IQs are above 70, and who can give informed consent.
Key exclusion criteria
Adults who has diagnoses as neuropsychiatric disorder and intellectual disorder, who is extreme myopia, who is pregnant, who have metal thing in a surface of a body, who can't control body temperatures adequately and who don't have ability to consent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Nuclear Medicine and Radiology
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL
022-717-8556
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Kobayashi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Nuclear Medicine and Radiology
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL
022-717-3572
Homepage URL
akiko.kobayashi.q6@dc.tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Institute of Development, Aging and Cancer, Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
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
| 2016 | Year | 05 | Month | 19 | 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
41
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
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2016 | Year | 05 | Month | 19 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025772
