UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of social behavior disorders in patients with higher brain dysfunction after traffic injury
Title of the study (Brief title)	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	Shutaro Nakaaki
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry, Laboratory of Aging, Behavior and Cognition
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL	03-3353-1211
Email	hzi05510@nifty.com

Public contact
Name of contact person	Shutaro Nakaaki
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry, Laboratory of
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015678