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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013730
Receipt No. R000015638
Scientific Title Investigation of symptomatology and underpinning neural network, and biomarkers of patients with focal and diffuse axonal brain injury
Date of disclosure of the study information 2014/04/16
Last modified on 2017/10/18

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Basic information
Public title Investigation of symptomatology and underpinning neural network, and biomarkers of patients with focal and diffuse axonal brain injury
Acronym Investigation on symptomatology and biomarkers of patients with brain injury
Scientific Title Investigation of symptomatology and underpinning neural network, and biomarkers of patients with focal and diffuse axonal brain injury
Scientific Title:Acronym Investigation on symptomatology and biomarkers of patients with brain injury
Region
Japan

Condition
Condition focal brain injury and diffuse axonal injury
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To make clear about the symptomatology and underpinning neural substrates of sequalae after traumatic brain injury. And to find predictors of those sequalae.
Basic objectives2 Others
Basic objectives -Others Elucidation of pathological condition and finding of predictors.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To assess the relationship between biomarkers at subacute stage and sequalae at chronic stage. And to assess structural and functional changes of injured brain at chronic stage.
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
16 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria patients with past history of traumatic head injury who had focal brain injury at the accident or had persistent disturbance of consciousness.
Key exclusion criteria those with past history of psychiatric or neuronal diseases or who had a history of illegal drug abuse or who had other head trauma before the accident.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keita Ueda
Organization Kyoto University Hospital
Division name Department of neuropsychiatry
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo, Kyoto,Japan
TEL 0757513383
Email uekei04@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keita Ueda
Organization Kyoto University Hospital
Division name Department of neuropsychiatry
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo, Kyoto,Japan
TEL 0757513383
Homepage URL
Email uekei04@kuhp.kyoto-u.ac.jp

Sponsor
Institute Neuropsychology group of department of neuropsychiatry, Kyoto University Hospital
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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 16 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 Preinitiation
Date of protocol fixation
2014 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Elucidating the characteristics of symptomatology both of focal and diffuse axonal brain injury and investigating underpinning neural substrates making use of structural and functional brain imaging technique. And also making clear whether or not there is some biomarkers at subacute stage which can predict neuropsychological sequalae at chronic stage.

Management information
Registered date
2014 Year 04 Month 16 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015638

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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