UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of symptomatology and underpinning neural network, and biomarkers of patients with focal and diffuse axonal brain injury
Title of the study (Brief title)	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	Keita Ueda
Organization	Kyoto University Hospital
Division name	Department of neuropsychiatry
Address	54 Shogoin-Kawaharacho, Sakyo, Kyoto,Japan
TEL	0757513383
Email	uekei04@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Keita Ueda
Organization	Kyoto University Hospital
Division name	Department of neuropsychiatry
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 03 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015638