UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019414 |
|---|---|
| Receipt number | R000022455 |
| Scientific Title | Rleationship between Meditation and Default Mode Network in Autistic people |
| Date of disclosure of the study information | 2015/10/20 |
| Last modified on | 2018/10/24 15:32:07 |
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Basic information
Public title
Rleationship between Meditation and Default Mode Network in Autistic people
Acronym
Meditation and DMN in Autism
Scientific Title
Rleationship between Meditation and Default Mode Network in Autistic people
Scientific Title:Acronym
Meditation and DMN 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 relationship between meditation and default mode network comparing autistic people with typical developmental people and the effect of meditation on subjective well-being.
Basic objectives2
Others
Basic objectives -Others
To revela the effect of meditation on DMN region with functional MRI technique and the effect of meditation on subjective well-being using a questionnaire.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional brain image and the score of subjective well-being before and after the intervention
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
Meditation intervention (1h/time, 10times, 10days)
Interventions/Control_2
Non-intervention
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
"Patients
1) Adults who were diagnosed as autism spectrum disorder based on DSM-IV-TR or V, and ADI-R.
2) Adults who do not have any severe neuropsychiatric disorders and physical illness.
3) Adults whose IQs are avobe 70, and who can give informed assent.
Typical control
1) Adults who do not have neuropsychiatric disorders and physical ilness.
2) Adults whose IQs are avobe 70, and who can give infromed assent."
Key exclusion criteria
Adults who has diagnoses as neuropsychiatric disorder and intellectual disorder and who do not have ability to assent.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Taki |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Nuclear Medicine and Radiology
Zip code
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 | |
| Middle name | |
| Last name | Hiroko Kamide |
Organization
Research Institute of Electrical Communication,Tohoku University
Division name
Systems and Software Division
Zip code
Address
2-1-1 Katahira, Aoba-ku, Sendai 980-8577, JAPAN
TEL
022-217-5543
Homepage URL
kamide@riec.tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Open-Type Research of Scentific research on innovative areas, a MEXT Grant-in-Aid project
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
東北大学加齢医学研究所／電気通信研究所
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 20 | 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
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 20 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022455
