UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013730 |
|---|---|
| Receipt number | 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 10:01:33 |
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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
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
uekei04@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Neuropsychology group of department of neuropsychiatry, Kyoto University Hospital
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015638
