UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004299 |
|---|---|
| Receipt number | R000005155 |
| Scientific Title | Prospective multicenter study of the incidence and predictors of chronic cognitive disorder after mild traumatic brain injury (MTBI) |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2012/04/27 10:26:11 |
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Basic information
Public title
Prospective multicenter study of the incidence and predictors of chronic cognitive disorder after mild traumatic brain injury (MTBI)
Acronym
Prospective multicenter study of the incidence and predictors of chronic cognitive disorder after mild traumatic brain injury (MTBI)
Scientific Title
Prospective multicenter study of the incidence and predictors of chronic cognitive disorder after mild traumatic brain injury (MTBI)
Scientific Title:Acronym
Prospective multicenter study of the incidence and predictors of chronic cognitive disorder after mild traumatic brain injury (MTBI)
Region
| Japan |
Condition
Condition
mild traumatic brain injury, cognitive disorder
Classification by specialty
| Psychiatry | Emergency medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the incidence and predictors of chronic cognitive disorder after mild traumatic brain injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The deterioration of MMSE, FrSBe, trail-making test, memory test, and word fluency test after 3 months from the incidence of mild traumatic brain injury.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with mild traumatic brain injury
Key exclusion criteria
1.Those who had penetrating head trauma,
multiple trauma, other disease causing
coma, and medication containing
tranquillizer or anti-epileptic drug
were excluded from the study.
2.In addition, those who were under 15
years old and whose GCS in ER were under
12 were also excluded from the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Nishiyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Primary Care and Emergency Medicine
Zip code
Address
54 Kawahara-chou, Shogoin, Sakyo-ku, 606-8507 Japan
TEL
0757513126
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Nishiyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Primary Care and Emergency Medicine
Zip code
Address
54 Kawahara-chou, Shogoin, Sakyo-ku, 606-8507 Japan
TEL
0757513126
Homepage URL
keinishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
京都大学医学研究科 初期診療救急医学分野（京都府）
京都大学医学研究科 精神医学分野（京都府）
国立病院機構 京都医療センター（京都府）
京都第一赤十字病院（京都府）
京都第二赤十字病院 （京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.tsutaeru.com/QQ/newsletter/newsletter63.html
Publication of results
Published
Result
URL related to results and publications
http://www.tsutaeru.com/QQ/newsletter/newsletter63.html
Number of participants that the trial has enrolled
Results
To the best of our knowledge, this is the first multi-center cohort analyses about cognitive disorder of patients with mild traumatic brain injury (MTBI). This study demonstrated low sensitivity of MMSE and CT imaging, which indicated that it might be that we needed to examine MTBI patients using other cognitive function test (e.g. trail-making test, memory test and word fluency test) and MRI.
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
| 2010 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 01 | Day |
Other
Other related information
This study is prospective observational multi-center study, which examine the incidence of chronic cognitive disorder after mild traumatic brain injury and the correlation between chronic cognitive disorder and clinical characteristics (e.g. age, sex, neuro-imaging abnormalities in acute phase).
Management information
Registered date
| 2010 | Year | 09 | Month | 30 | Day |
Last modified on
| 2012 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005155
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
