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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013425
Receipt No. R000015678
Scientific Title Investigation of social behavior disorders in patients with higher brain dysfunction after traffic injury
Date of disclosure of the study information 2014/03/14
Last modified on 2018/03/17

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Basic information
Public title Investigation of social behavior disorders in patients with higher brain dysfunction after traffic injury
Acronym Investigation of social behavior disorders after traffic injury
Scientific Title Investigation of social behavior disorders in patients with higher brain dysfunction after traffic injury
Scientific Title:Acronym Investigation of social behavior disorders after traffic injury
Region
Japan

Condition
Condition Patietns with higher brain dysfunction after the traffic injury
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the neural basis of social behavior disorders in patients with higher brain dysfunction after traffic injury used by multi-modal analysis (mainly used by diffusion tensor imaging and near-infrared spectroscopy (NIRS))
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes diffusion tensor imaging and near-infrared spectroscopy (NIRS)
Key secondary outcomes Both cognitive assessment and social behavior assessment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Behavior,custom Other
Interventions/Control_1 The patients were performed with cognitive assessment ,
social behavior assessment,
and diffusion tensor imaging,
near-infrared spectroscopy
during eight weeks.
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Traumatic injury after traffic accident,
The patient has a focal brain injury or diffuse axonal injury, The patient meets criteria of higher brain dysfunction
,More than 30 days passed after the brain injury, The patient has the family who lives withReliable informed consent could be obtained from the patient and or his relatives
Key exclusion criteria A previous history of mental disorders,
The patient has pacemaker,The patient with severe physical disease,The patient with severe mental state
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shutaro Nakaaki
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry, Laboratory of Aging, Behavior and Cognition
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL 03-3353-1211
Email hzi05510@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Shutaro Nakaaki
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry, Laboratory of
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL 03-3353-1211
Homepage URL
Email hzi05510@nifty.com

Sponsor
Institute Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department

Funding Source
Organization The general insurance association of Japan
Organization
Division
Category of Funding Organization Non profit foundation
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 慶應義塾大学病院(東京都)   Keio University School of Medicine (Tokyo)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 14 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
2014 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 14 Day
Last modified on
2018 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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