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

Email



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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name