UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008562 |
|---|---|
| Receipt number | R000010066 |
| Scientific Title | Neural underpinnings of a vulunerability factor, an acquired sign, and a resilience process of post-earthquake stress. |
| Date of disclosure of the study information | 2012/07/30 |
| Last modified on | 2016/08/02 10:54:48 |
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Basic information
Public title
Neural underpinnings of a vulunerability factor, an acquired sign, and a resilience process of post-earthquake stress.
Acronym
A severe disaster impacts on human cognition and behaviors.
Scientific Title
Neural underpinnings of a vulunerability factor, an acquired sign, and a resilience process of post-earthquake stress.
Scientific Title:Acronym
A severe disaster impacts on human cognition and behaviors.
Region
| Japan |
Condition
Condition
Posttraumatic stress disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To reveal the neural underpinnings of a vulnerability factor, acquired sign and a resilience process f post-earthquake stress.
Basic objectives2
Others
Basic objectives -Others
Psychiatric symptoms
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Gray matter volume
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Right-handed healthy subjects
Key exclusion criteria
History of psychiatric diseases, traumatic brain injury
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Kawashima |
Organization
IDAC, Tohoku University
Division name
Functional Brain Imaging
Zip code
Address
4-1 Seiryou-machi, Aoba-ku, Sendai
TEL
022-717-7988
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Sekiguchi |
Organization
IDAC, Tohoku university
Division name
Advanced Brain Science
Zip code
Address
TEL
022-717-7988
Homepage URL
asekiguchi@idac.tohoku.ac.jp
Sponsor or person
Institute
IDAC, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
MHLW, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 02 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective design for data of pre-earthquake and soon after the earthquake. Prospective design for follow up data and those of control group.
Management information
Registered date
| 2012 | Year | 07 | Month | 30 | Day |
Last modified on
| 2016 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010066
