UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013425 |
|---|---|
| Receipt number | 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 22:12:54 |
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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
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
hzi05510@nifty.com
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015678
